<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/NCT03236324</url>
  </required_header>
  <id_info>
    <org_study_id>REB15-2238</org_study_id>
    <nct_id>NCT03236324</nct_id>
  </id_info>
  <brief_title>Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery</brief_title>
  <official_title>Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the efficacy of a bilateral TFP block in parturients&#xD;
      undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric&#xD;
      rated pain scores in two groups (TFP block with saline (control) and TFP block with local&#xD;
      anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class&#xD;
      1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal&#xD;
      anesthesia at the South Health Campus will be consented to participate in the study. Patients&#xD;
      will be randomly assigned using a computer-generated table of random numbers to two groups.&#xD;
      Group allocations will be concealed. All patients will receive spinal anesthesia with spinal&#xD;
      Morphine according to our institutional protocol. At the end of surgery, randomized patients&#xD;
      will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5&#xD;
      mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2&#xD;
      anesthesiologists experienced in performing this block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caesarean delivery (CD) is one of the most commonly performed surgical procedures with an&#xD;
      estimated annual frequency of 27% in Alberta between 2007-2011. Poorly controlled&#xD;
      postsurgical pain is associated with an increase in morbidity. Untreated or undertreated pain&#xD;
      can lead to respiratory infections secondary to splinting and shallow breathing. Excessive&#xD;
      pain also reduces and delays ambulation, which can lead to both an increase in the incidence&#xD;
      of deep vein thrombosis (DVT) and delay recovery and readiness for discharge. Poorly&#xD;
      controlled pain may also lead to the development of chronic postsurgical pain. The optimal&#xD;
      form of postoperative analgesia following CD is not known. Most postoperative analgesic&#xD;
      protocols for CD, despite being multimodal in nature, rely heavily on opioid medications both&#xD;
      orally and intrathecally for analgesia. These medications, however, are not without serious&#xD;
      side effects such as nausea, vomiting, sedation, addiction or dependence, and respiratory&#xD;
      depression as well as expression in breast milk which may put infants at risk of side effects&#xD;
      as well. Thus, an effective alternative analgesic modality analgesia in these patients which&#xD;
      produces both improved pain control and reduced side effects is desired. The TFP block&#xD;
      represents a promising alternative, which may fulfill this role in complementing multimodal&#xD;
      analgesia for patients undergoing CD and reducing opioid administration.&#xD;
&#xD;
      This project aims to elucidate information regarding alternative interventions for&#xD;
      postoperative analgesia following CD. While the most common analgesic regimen of intrathecal&#xD;
      and oral opioids, acetaminophen, and NSAIDS for postoperative analgesia is effective, it is&#xD;
      not appropriate for all patients. For those who cannot receive intrathecal opioids (e.g.&#xD;
      those with allergies to opioid medications, or those who are undergoing CD under general&#xD;
      anesthetic), alternative analgesic modalities are important to provide adequate multimodal&#xD;
      analgesia and minimize side effects of each of the analgesic medications. Additionally, this&#xD;
      aforementioned common analgesic pathway may itself be further optimized through the addition&#xD;
      of new analgesic techniques. The Transversalis Fascia Plane (TFP) block is a nerve block,&#xD;
      which could potentially target nerves responsible for transmitting pain following CD, and&#xD;
      represents a promising novel analgesic modality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">December 11, 2022</completion_date>
  <primary_completion_date type="Actual">October 13, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative opioid consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>24-hour postoperative opioid consumption presented in morphine equivalents</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale pain scores</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Pain scores to be assessed at rest and movement 6, 12, 18, 24 and 48 hours post-Cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first analgesia</measure>
    <time_frame>48 hours</time_frame>
    <description>Time to request of first analgesia after Cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid side effects</measure>
    <time_frame>48 hours</time_frame>
    <description>Evaluate incidence of nausea, vomiting, pruritus, sedation after Cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>48 hours</time_frame>
    <description>Evaluate patient satisfaction of postoperative pain relief at time of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery scores</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Quality of recovery (QoR-15) scores acquired preoperatively, 24 hour and 48 hours after Cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-discharge numeric rating pain scale scores</measure>
    <time_frame>up to 60 days</time_frame>
    <description>Evaluate pain scores at 30 days and 60 days after Cesarean delivery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>TFP block with saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TFP block with local anesthetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound-guided nerve block</intervention_name>
    <description>Transversalis fascia plane (TFP) block, ultrasound-guided</description>
    <arm_group_label>TFP block with local anesthetic</arm_group_label>
    <arm_group_label>TFP block with saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>20 mL 0.9% saline administered on each side as bilateral TFP blocks</description>
    <arm_group_label>TFP block with saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine-epinephrine</intervention_name>
    <description>20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks</description>
    <arm_group_label>TFP block with local anesthetic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective Cesarean delivery with spinal anesthesia at South Health Campus&#xD;
&#xD;
          -  term gestation with a singleton pregnancy&#xD;
&#xD;
          -  American Society of Anesthesiologists' (ASA) physical status Class 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  language barrier&#xD;
&#xD;
          -  body mass index (BMI) &gt; 40 kg/m2&#xD;
&#xD;
          -  multiple gestations&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
          -  opioid use&#xD;
&#xD;
          -  substance abuse&#xD;
&#xD;
          -  allergies to study medication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>South Health Campus</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3M 1M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</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>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03236324
org study id: REB15-2238
nct id: NCT03236324
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the efficacy of a bilateral TFP block in parturients
      undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric
      rated pain scores in two groups (TFP block with saline (control) and TFP block with local
      anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class
      1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal
      anesthesia at the South Health Campus will be consented to participate in the study. Patients
      will be randomly assigned using a computer-generated table of random numbers to two groups.
      Group allocations will be concealed. All patients will receive spinal anesthesia with spinal
      Morphine according to our institutional protocol. At the end of surgery, randomized patients
      will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5
      mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2
      anesthesiologists experienced in performing this block.
Caesarean delivery (CD) is one of the most commonly performed surgical procedures with an
      estimated annual frequency of 27% in Alberta between 2007-2011. Poorly controlled
      postsurgical pain is associated with an increase in morbidity. Untreated or undertreated pain
      can lead to respiratory infections secondary to splinting and shallow breathing. Excessive
      pain also reduces and delays ambulation, which can lead to both an increase in the incidence
      of deep vein thrombosis (DVT) and delay recovery and readiness for discharge. Poorly
      controlled pain may also lead to the development of chronic postsurgical pain. The optimal
      form of postoperative analgesia following CD is not known. Most postoperative analgesic
      protocols for CD, despite being multimodal in nature, rely heavily on opioid medications both
      orally and intrathecally for analgesia. These medications, however, are not without serious
      side effects such as nausea, vomiting, sedation, addiction or dependence, and respiratory
      depression as well as expression in breast milk which may put infants at risk of side effects
      as well. Thus, an effective alternative analgesic modality analgesia in these patients which
      produces both improved pain control and reduced side effects is desired. The TFP block
      represents a promising alternative, which may fulfill this role in complementing multimodal
      analgesia for patients undergoing CD and reducing opioid administration.

      This project aims to elucidate information regarding alternative interventions for
      postoperative analgesia following CD. While the most common analgesic regimen of intrathecal
      and oral opioids, acetaminophen, and NSAIDS for postoperative analgesia is effective, it is
      not appropriate for all patients. For those who cannot receive intrathecal opioids (e.g.
      those with allergies to opioid medications, or those who are undergoing CD under general
      anesthetic), alternative analgesic modalities are important to provide adequate multimodal
      analgesia and minimize side effects of each of the analgesic medications. Additionally, this
      aforementioned common analgesic pathway may itself be further optimized through the addition
      of new analgesic techniques. The Transversalis Fascia Plane (TFP) block is a nerve block,
      which could potentially target nerves responsible for transmitting pain following CD, and
      represents a promising novel analgesic modality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Postoperative opioid consumption
time frame: 24 hours
description: 24-hour postoperative opioid consumption presented in morphine equivalents
measure: Numeric rating scale pain scores
time frame: up to 48 hours
description: Pain scores to be assessed at rest and movement 6, 12, 18, 24 and 48 hours post-Cesarean delivery
measure: Time to first analgesia
time frame: 48 hours
description: Time to request of first analgesia after Cesarean delivery
measure: Opioid side effects
time frame: 48 hours
description: Evaluate incidence of nausea, vomiting, pruritus, sedation after Cesarean delivery
measure: Patient satisfaction
time frame: 48 hours
description: Evaluate patient satisfaction of postoperative pain relief at time of discharge
measure: Quality of recovery scores
time frame: up to 48 hours
description: Quality of recovery (QoR-15) scores acquired preoperatively, 24 hour and 48 hours after Cesarean delivery
measure: Post-discharge numeric rating pain scale scores
time frame: up to 60 days
description: Evaluate pain scores at 30 days and 60 days after Cesarean delivery
arm group label: TFP block with saline
arm group type: Placebo Comparator
description: Placebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot
arm group label: TFP block with local anesthetic
arm group type: Experimental
description: Experimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot
intervention type: Device
intervention name: ultrasound-guided nerve block
description: Transversalis fascia plane (TFP) block, ultrasound-guided
arm group label: TFP block with local anesthetic
arm group label: TFP block with saline
intervention type: Drug
intervention name: Saline
description: 20 mL 0.9% saline administered on each side as bilateral TFP blocks
arm group label: TFP block with saline
intervention type: Drug
intervention name: Bupivacaine-epinephrine
description: 20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks
arm group label: TFP block with local anesthetic
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Epinephrine
mesh term: Bupivacaine