<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260972</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00129099</org_study_id>
    <nct_id>NCT03260972</nct_id>
  </id_info>
  <brief_title>Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control</brief_title>
  <official_title>An Evaluation of Intraabdominal Chloroprocaine During Cesarean Delivery and Its Effect on Postoperative Pain and Nausea; a Randomized Controlled Trial &amp; Pharmacokinetic-pharmacodynamics (PKPD) Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective The objective of this study is to test the hypothesis that instillation of&#xD;
      intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased&#xD;
      postoperative pain and nausea compared to placebo, without increasing intraoperative and&#xD;
      postoperative complications.&#xD;
&#xD;
      Methods The investigators plan to randomize about 150 women undergoing primary and repeat&#xD;
      cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal&#xD;
      closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to&#xD;
      the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to&#xD;
      participate in the study. The investigators' primary outcome measure will be postoperative&#xD;
      pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary&#xD;
      outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and&#xD;
      during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects,&#xD;
      pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital&#xD;
      stay. Analysis will follow the intention-to-treat principle.&#xD;
&#xD;
      The investigators will also be studying the concentration/effect (PKPD) relationship of&#xD;
      chloroprocaine use for pain control in the postpartum period. The time courses of the plasma&#xD;
      concentrations of chloroprocaine will be analyzed with mixed effects&#xD;
      pharmacokinetic-pharmacodynamic (PKPD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain relief is an important consideration during and after cesarean section.&#xD;
      Although many different methods have been described for proper pain relief, it remains not&#xD;
      sufficient and satisfactory in some patients.1,2 The overprescribing of opioids has reached a&#xD;
      critical level worldwide, and cesarean section may be the trigger for long-term opioid use in&#xD;
      many patients.1,2,3 The optimal strategy for perioperative pain control consists of&#xD;
      multimodal therapy to minimize the need for opioids, with the goals of perioperative pain&#xD;
      management being to relieve suffering, achieve early mobilization after surgery, reduce&#xD;
      length of hospital stay, and achieve patient satisfaction. Currently, most obstetricians use&#xD;
      a combination of opioids and NSAIDs for pain control postpartum. These pain control regimens&#xD;
      take into account medical, psychological, and physical condition of women, age, level of fear&#xD;
      or anxiety, allergies and personal preference at the time of cesarean section. Due to several&#xD;
      aspects such as maternal and neonatal wellbeing, postoperative pain relief in cesarean&#xD;
      delivery is crucial. Therefore, providing a proper regimen with very quick onset of action,&#xD;
      devoid of renal or gastrointestinal complications, and devoid of complications of neonatal&#xD;
      abstinence syndrome (NAS) becomes necessary.&#xD;
&#xD;
      Local anesthetics have been extensively used at the time of cesarean section. Chloroprocaine&#xD;
      (Nesacaine) is an ester-type local anesthetic (active ingredient - benzoic acid,&#xD;
      4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride that has been used as an&#xD;
      anesthetic and analgesic in obstetrics &amp; gynecology. It has a rapid onset time of action&#xD;
      (usually within 6 to 12 minutes; 9.6 min ± 7.3 min at 40 mg dose; 7.9 min ± 6.0 min at 50 mg&#xD;
      dose) and a motor block action lasting for 40 minutes to 2 hours.4 Chloroprocaine, like other&#xD;
      local anesthetics, blocks the generation and the conduction of nerve impulses, presumably by&#xD;
      increasing the threshold for electrical excitation in the nerve, by slowing the propagation&#xD;
      of the nerve impulse and by reducing the rate of rise of the action potential. In general,&#xD;
      the progression of anesthesia is related to the diameter, myelination and conduction velocity&#xD;
      of affected nerve fibers.&#xD;
&#xD;
      The rate of intra-abdominal chloroprocaine absorption is dependent upon the total dose and&#xD;
      concentration administered and the presence or absence of epinephrine in the anesthetic&#xD;
      injection. Epinephrine usually reduces the rate of absorption and plasma concentration of&#xD;
      local anesthetics and is sometimes added to local anesthetic injections in order to prolong&#xD;
      the duration of action. Various pharmacokinetic parameters of chloroprocaine can be&#xD;
      significantly altered by the presence of hepatic or renal disease, addition of epinephrine,&#xD;
      factors affecting urinary pH, renal blood flow, and the age of the patient. Chloroprocaine is&#xD;
      rapidly metabolized in plasma by hydrolysis of the ester linkage by pseudocholinesterase. The&#xD;
      hydrolysis of chloroprocaine results in the production of ß-diethylaminoethanol and&#xD;
      2-chloro-4-aminobenzoic acid, which inhibits the action of the sulfonamides. The kidney is&#xD;
      the main excretory organ for chloroprocaine and its metabolites. Urinary excretion is&#xD;
      affected by urinary perfusion and factors affecting urinary pH. Due to its short duration of&#xD;
      action, favorable safety profile, and very low toxicity, it has been used extensively for&#xD;
      spinal anesthesia at the time of cesarean section.5,6 It has also been used for skin&#xD;
      infiltration to reduce pain post cesarean section in patients who cannot receive spinal&#xD;
      analgesia due to contraindications.7 However, despite its advantages as an analgesic and&#xD;
      anesthetic, it has never clinically evaluated to be used intra-abdominally at the time of&#xD;
      cesarean section. Although its occasional use has been considered and employed in certain&#xD;
      clinical circumstances, clinical evaluation has not been attempted.&#xD;
&#xD;
      The goal of this study is to employ a well-designed randomized controlled clinical trial to&#xD;
      compare the efficacy of intraabdominal chloroprocaine administration versus placebo (sterile&#xD;
      saline) for pain control at the time of cesarean section. The investigators hypothesize that&#xD;
      intra-abdominal chloroprocaine administration at the time of cesarean delivery is associated&#xD;
      with decreased postoperative pain and nausea compared to non-administration of&#xD;
      chloroprocaine. Patients admitted for cesarean section and meeting inclusion criteria will be&#xD;
      approached for consent. Consented patients will then be randomized into two groups.&#xD;
&#xD;
      Group 1: (intraabdominal chloroprocaine administration): These participants will have&#xD;
      intraabdominal chloroprocaine administration at the time of cesarean section before fascial&#xD;
      closure.&#xD;
&#xD;
      Group 2: (Intraabdominal instillation of placebo (sterile saline): These participants will&#xD;
      have placebo (sterile saline) administered at the time of cesarean delivery before fascial&#xD;
      closure. Cesarean delivery will continue traditionally, including fascial and skin closure.&#xD;
&#xD;
      Assignment will be performed by opening a sequentially numbered opaque envelope containing&#xD;
      computer-randomized individual allocations. The envelope will be opened by the circulation&#xD;
      nurse in the operating room and silently viewed by the surgeons prior to surgery.&#xD;
      Instructions will be given to not verbalize the treatment arm revealed. The original&#xD;
      randomization will be performed by research staff before the initiation of the study using a&#xD;
      random number table generator, and the participants will be blinded to treatment once&#xD;
      assigned. Information regarding basic demographic data, interventions during the cesarean&#xD;
      delivery and postpartum course will be obtained from the participant's charts after discharge&#xD;
      from the hospital. The patients will be assessed for pain control, nausea and vomiting after&#xD;
      cesarean section. The protocol for labor management and fetal monitoring will be the same for&#xD;
      both groups, including continuous electronic fetal monitoring prior to delivery.&#xD;
&#xD;
      Both groups will undergo inspection of the uterine incision, with or without closure of the&#xD;
      vesicouterine peritoneum (bladder flap), abdominal peritoneum, or rectus muscles per&#xD;
      attending preference. Both groups will undergo standard closure of the abdominal fascia,&#xD;
      consisting of suturing with a running non locking delayed absorbable suture. Irrigation of&#xD;
      the subcutaneous tissues superior to the closed fascia will be performed in both groups.&#xD;
      Staples or absorbable suture will be used for skin closure. In addition, all participants&#xD;
      will receive a standardized dose of 1-2 g cefazolin intravenously as antibiotic prophylaxis&#xD;
      before the start of surgery. Participants with cefazolin allergy will receive 900 mg&#xD;
      clindamycin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn by IRB&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients admitted for cesarean section and meeting inclusion criteria will be approached for consent. Consented patients will then be randomized into two groups.&#xD;
Group 1: (intraabdominal chloroprocaine administration): These participants will have intraabdominal chloroprocaine administration at the time of cesarean section before fascial closure.&#xD;
Group 2: (Intraabdominal instillation of placebo (sterile water): These participants will have placebo (normal saline) administered at the time of cesarean section before fascial closure. Cesarean section will proceed traditionally, including fascial and skin closure.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigator and patients will be masked from the treatment options. The care providers will not be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue scale (VAS) at 1 hour after skin closure</measure>
    <time_frame>Immediately following cesarean section to 1 hour after skin closure</time_frame>
    <description>Our primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hours after skin closure (sitting in an upright position and movement of lower extremities) after cesarean section. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization</measure>
    <time_frame>2, 6, 24 and 48 hours after cesarean section</time_frame>
    <description>Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of chloroprocaine (gastrointestinal side effects, pruritus)</measure>
    <time_frame>Day 0 to 2 weeks after delivery</time_frame>
    <description>An adverse effect is an undesired harmful effect resulting from chloroprocaine use. Adverse effects of chloroprocaine include gastrointestinal (nausea, vomiting), dizziness, rash, itching, redness and anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant analgesic requirement</measure>
    <time_frame>Day 0 to 4 weeks after delivery</time_frame>
    <description>The patients will be evaluated for increased analgesic requirement after use of chloroprocaine or placebo. The total amount of analgesia used will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmissions for pain</measure>
    <time_frame>Day 0 to 6 weeks after delivery</time_frame>
    <description>A hospital readmission for pain is an episode when a patient who had been adequately pain controlled is discharged from a hospital is admitted again within a specified time interval for poor pain control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Day 0 to 1 week after delivery</time_frame>
    <description>This is defined as the number of days the patient stays in the hospital after cesarean section.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cesarean Section Complications</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Chloroprocaine arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 mls of normal saline will be instilled into the abdomen prior to fascia closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroprocaine Hcl 2% Inj</intervention_name>
    <description>20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.</description>
    <arm_group_label>Chloroprocaine arm</arm_group_label>
    <other_name>Nesacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>20 mls of normal saline will be instilled into the abdomen prior to fascia closure.</description>
    <arm_group_label>Normal saline arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with a singleton or multiple pregnancies, vertex or breech presentation&#xD;
             presenting to our labor and delivery unit for an elective cesarean section will be&#xD;
             eligible for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women will be excluded if any of the following criteria are encountered: Allergy&#xD;
             against local anesthetics - ascertained or presumptive hypersensitivity to the ester&#xD;
             type and major anesthetics; chronic pelvic pain and refusal to participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahizechukwu Eke, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroprocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No personal patient data will be shared with other researchers. The final de-identified manuscript will be published.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260972
org study id: IRB00129099
nct id: NCT03260972
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Objective The objective of this study is to test the hypothesis that instillation of
      intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased
      postoperative pain and nausea compared to placebo, without increasing intraoperative and
      postoperative complications.

      Methods The investigators plan to randomize about 150 women undergoing primary and repeat
      cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal
      closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to
      the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to
      participate in the study. The investigators' primary outcome measure will be postoperative
      pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary
      outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and
      during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects,
      pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital
      stay. Analysis will follow the intention-to-treat principle.

      The investigators will also be studying the concentration/effect (PKPD) relationship of
      chloroprocaine use for pain control in the postpartum period. The time courses of the plasma
      concentrations of chloroprocaine will be analyzed with mixed effects
      pharmacokinetic-pharmacodynamic (PKPD).
Postoperative pain relief is an important consideration during and after cesarean section.
      Although many different methods have been described for proper pain relief, it remains not
      sufficient and satisfactory in some patients.1,2 The overprescribing of opioids has reached a
      critical level worldwide, and cesarean section may be the trigger for long-term opioid use in
      many patients.1,2,3 The optimal strategy for perioperative pain control consists of
      multimodal therapy to minimize the need for opioids, with the goals of perioperative pain
      management being to relieve suffering, achieve early mobilization after surgery, reduce
      length of hospital stay, and achieve patient satisfaction. Currently, most obstetricians use
      a combination of opioids and NSAIDs for pain control postpartum. These pain control regimens
      take into account medical, psychological, and physical condition of women, age, level of fear
      or anxiety, allergies and personal preference at the time of cesarean section. Due to several
      aspects such as maternal and neonatal wellbeing, postoperative pain relief in cesarean
      delivery is crucial. Therefore, providing a proper regimen with very quick onset of action,
      devoid of renal or gastrointestinal complications, and devoid of complications of neonatal
      abstinence syndrome (NAS) becomes necessary.

      Local anesthetics have been extensively used at the time of cesarean section. Chloroprocaine
      (Nesacaine) is an ester-type local anesthetic (active ingredient - benzoic acid,
      4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride that has been used as an
      anesthetic and analgesic in obstetrics & gynecology. It has a rapid onset time of action
      (usually within 6 to 12 minutes; 9.6 min ± 7.3 min at 40 mg dose; 7.9 min ± 6.0 min at 50 mg
      dose) and a motor block action lasting for 40 minutes to 2 hours.4 Chloroprocaine, like other
      local anesthetics, blocks the generation and the conduction of nerve impulses, presumably by
      increasing the threshold for electrical excitation in the nerve, by slowing the propagation
      of the nerve impulse and by reducing the rate of rise of the action potential. In general,
      the progression of anesthesia is related to the diameter, myelination and conduction velocity
      of affected nerve fibers.

      The rate of intra-abdominal chloroprocaine absorption is dependent upon the total dose and
      concentration administered and the presence or absence of epinephrine in the anesthetic
      injection. Epinephrine usually reduces the rate of absorption and plasma concentration of
      local anesthetics and is sometimes added to local anesthetic injections in order to prolong
      the duration of action. Various pharmacokinetic parameters of chloroprocaine can be
      significantly altered by the presence of hepatic or renal disease, addition of epinephrine,
      factors affecting urinary pH, renal blood flow, and the age of the patient. Chloroprocaine is
      rapidly metabolized in plasma by hydrolysis of the ester linkage by pseudocholinesterase. The
      hydrolysis of chloroprocaine results in the production of ß-diethylaminoethanol and
      2-chloro-4-aminobenzoic acid, which inhibits the action of the sulfonamides. The kidney is
      the main excretory organ for chloroprocaine and its metabolites. Urinary excretion is
      affected by urinary perfusion and factors affecting urinary pH. Due to its short duration of
      action, favorable safety profile, and very low toxicity, it has been used extensively for
      spinal anesthesia at the time of cesarean section.5,6 It has also been used for skin
      infiltration to reduce pain post cesarean section in patients who cannot receive spinal
      analgesia due to contraindications.7 However, despite its advantages as an analgesic and
      anesthetic, it has never clinically evaluated to be used intra-abdominally at the time of
      cesarean section. Although its occasional use has been considered and employed in certain
      clinical circumstances, clinical evaluation has not been attempted.

      The goal of this study is to employ a well-designed randomized controlled clinical trial to
      compare the efficacy of intraabdominal chloroprocaine administration versus placebo (sterile
      saline) for pain control at the time of cesarean section. The investigators hypothesize that
      intra-abdominal chloroprocaine administration at the time of cesarean delivery is associated
      with decreased postoperative pain and nausea compared to non-administration of
      chloroprocaine. Patients admitted for cesarean section and meeting inclusion criteria will be
      approached for consent. Consented patients will then be randomized into two groups.

      Group 1: (intraabdominal chloroprocaine administration): These participants will have
      intraabdominal chloroprocaine administration at the time of cesarean section before fascial
      closure.

      Group 2: (Intraabdominal instillation of placebo (sterile saline): These participants will
      have placebo (sterile saline) administered at the time of cesarean delivery before fascial
      closure. Cesarean delivery will continue traditionally, including fascial and skin closure.

      Assignment will be performed by opening a sequentially numbered opaque envelope containing
      computer-randomized individual allocations. The envelope will be opened by the circulation
      nurse in the operating room and silently viewed by the surgeons prior to surgery.
      Instructions will be given to not verbalize the treatment arm revealed. The original
      randomization will be performed by research staff before the initiation of the study using a
      random number table generator, and the participants will be blinded to treatment once
      assigned. Information regarding basic demographic data, interventions during the cesarean
      delivery and postpartum course will be obtained from the participant's charts after discharge
      from the hospital. The patients will be assessed for pain control, nausea and vomiting after
      cesarean section. The protocol for labor management and fetal monitoring will be the same for
      both groups, including continuous electronic fetal monitoring prior to delivery.

      Both groups will undergo inspection of the uterine incision, with or without closure of the
      vesicouterine peritoneum (bladder flap), abdominal peritoneum, or rectus muscles per
      attending preference. Both groups will undergo standard closure of the abdominal fascia,
      consisting of suturing with a running non locking delayed absorbable suture. Irrigation of
      the subcutaneous tissues superior to the closed fascia will be performed in both groups.
      Staples or absorbable suture will be used for skin closure. In addition, all participants
      will receive a standardized dose of 1-2 g cefazolin intravenously as antibiotic prophylaxis
      before the start of surgery. Participants with cefazolin allergy will receive 900 mg
      clindamycin.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients admitted for cesarean section and meeting inclusion criteria will be approached for consent. Consented patients will then be randomized into two groups.
Group 1: (intraabdominal chloroprocaine administration): These participants will have intraabdominal chloroprocaine administration at the time of cesarean section before fascial closure.
Group 2: (Intraabdominal instillation of placebo (sterile water): These participants will have placebo (normal saline) administered at the time of cesarean section before fascial closure. Cesarean section will proceed traditionally, including fascial and skin closure.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The investigator and patients will be masked from the treatment options. The care providers will not be masked.
measure: Visual analogue scale (VAS) at 1 hour after skin closure
time frame: Immediately following cesarean section to 1 hour after skin closure
description: Our primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hours after skin closure (sitting in an upright position and movement of lower extremities) after cesarean section. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.
measure: Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization
time frame: 2, 6, 24 and 48 hours after cesarean section
description: Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.
measure: Adverse effects of chloroprocaine (gastrointestinal side effects, pruritus)
time frame: Day 0 to 2 weeks after delivery
description: An adverse effect is an undesired harmful effect resulting from chloroprocaine use. Adverse effects of chloroprocaine include gastrointestinal (nausea, vomiting), dizziness, rash, itching, redness and anxiety.
measure: Concomitant analgesic requirement
time frame: Day 0 to 4 weeks after delivery
description: The patients will be evaluated for increased analgesic requirement after use of chloroprocaine or placebo. The total amount of analgesia used will be recorded.
measure: Hospital readmissions for pain
time frame: Day 0 to 6 weeks after delivery
description: A hospital readmission for pain is an episode when a patient who had been adequately pain controlled is discharged from a hospital is admitted again within a specified time interval for poor pain control.
measure: Length of hospital stay
time frame: Day 0 to 1 week after delivery
description: This is defined as the number of days the patient stays in the hospital after cesarean section.
arm group label: Chloroprocaine arm
arm group type: Active Comparator
description: 20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.
arm group label: Normal saline arm
arm group type: Placebo Comparator
description: 20 mls of normal saline will be instilled into the abdomen prior to fascia closure.
intervention type: Drug
intervention name: Chloroprocaine Hcl 2% Inj
description: 20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.
arm group label: Chloroprocaine arm
other name: Nesacaine
intervention type: Drug
intervention name: Normal saline
description: 20 mls of normal saline will be instilled into the abdomen prior to fascia closure.
arm group label: Normal saline arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ahizechukwu Eke, MD MPH
role: Principal Investigator
affiliation: Johns Hopkins University
responsible party type: Sponsor
mesh term: Chloroprocaine
sharing ipd: No
ipd description: No personal patient data will be shared with other researchers. The final de-identified manuscript will be published.