xml: <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/NCT06020196</url>
    </required_header>
    <id_info>
      <org_study_id>71</org_study_id>
      <nct_id>NCT06020196</nct_id>
    </id_info>
    <brief_title>The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery</brief_title>
    <official_title>The Safety and Efficacy of Surgical Rectus Sheath Block Compared to Subdermal Infiltration of Local Anaesthetic for Postoperative Analgesia After Elective Cesarean Section: a Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahmed M Maged, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        All participants will receive spinal anaesthesia and will be randomly divided into 2 equal&#xD;
        groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to&#xD;
        the rectus sheath space under direct vision before closure of the anterior abdominal wall.&#xD;
        Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution&#xD;
        before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25%&#xD;
        Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All participants will receive spinal anaesthesia and will be randomly divided into 2 equal&#xD;
        groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to&#xD;
        the rectus sheath space under direct vision before closure of the anterior abdominal wall.&#xD;
        Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution&#xD;
        before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25%&#xD;
        Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.&#xD;
  &#xD;
        All cases will be followed up hourly for 6 hours postoperative for assessment of level of&#xD;
        pain by using visual analog scale (VAS). Primary outcome parameters were VAS score during&#xD;
        rest and the need for additional analgesics during the first 48 post-operative hours. Other&#xD;
        parameters will be time of start of lactation and ambulation, length of post-operative&#xD;
        hospital stay, and occurrence of side effects or complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</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>This study will be a prospective, single-blinded, randomized controlled trial (RCT) that include 182 patients scheduled for an elective lower segment Cesarean section at the Obstetrics and Gynecology department of Kasr Alainy University Hospital from April 2023 to August 2023.&#xD;
  After obtaining approval from the hospital's institutional review board, we assessed 182 young women scheduled for an elective lower segment Cesarean section to determine their eligibility for the study.&#xD;
  The182 patients admitted to be enrolled in our study, in which they're randomized into 2 groups, Group 1(n= 91) received bilateral surgical rectus sheath block and Group 2 (n =91) received subdermal infiltration of local anaesthetics.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative pain during rest</measure>
      <time_frame>6 hours</time_frame>
      <description>All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the amount of additional analgesics consumption post-operatively for pain relief.</measure>
      <time_frame>48 hours</time_frame>
      <description>assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>time of start of lactation</measure>
      <time_frame>24 hours</time_frame>
      <description>the interval between skin closure and the time the patient first breastfeeds her newborn.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time of start of ambulation</measure>
      <time_frame>24 hours</time_frame>
      <description>the interval between skin closure and the time patient first ambulated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of post-operative hospital stay</measure>
      <time_frame>24 hours</time_frame>
      <description>the interval between skin closure and the time patient discharged from hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>development of of side effects or complications.</measure>
      <time_frame>24 hours</time_frame>
      <description>The patient was observed for potential complications of RSB:&#xD;
  The superior and inferior epigastric arteries are at risk of injury Visceral damage, Local anesthetic systemic toxicity, leading to seizures or ventricular arrhythmias (rare) Incomplete block may result from anatomical variance, as in up to 30% of the population.&#xD;
  Failure of the block as the posterior wall of the rectus sheath lying superficial to the peritoneal cavity, needle misplacement may lead to injection into the peritoneal cavity.&#xD;
  Infection.&#xD;
  The patient was observed for potential complications of subdermal local anesthetic infilteration, including wound infection&#xD;
  also the paients were observed for developemt of NSAID side effec</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">182</enrollment>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>Rectus sheath block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participants will receive bilateral surgical rectus sheath block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Subdermal group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participants will receive subdermal infiltration of local anaesthetics.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>surgical rectus sheath block</intervention_name>
      <description>Local anaesthetic will be administered into the rectus sheath space by the surgeon, towards the end of the operation, at the time of closure of the anterior abdominal wall (before the closure of peritoneum)</description>
      <arm_group_label>Rectus sheath block group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>subdermal local anaesthetic infiltration</intervention_name>
      <description>After closure of the subcutaneous fat, the edges of the skin become more stable; subdermal Infiltration with moving needle technique was done to optimize distribution of the local anesthetic solution</description>
      <arm_group_label>Subdermal group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women with singleton pregnancies.&#xD;
  &#xD;
            -  Gestational age 37 to 41 weeks.&#xD;
  &#xD;
            -  Surgical history: no history of previous surgeries or history of previous 1 cesarean&#xD;
               section,&#xD;
  &#xD;
            -  Age: 20 -35 years old,&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status classifications II (healthy&#xD;
               pregnancy or with mild systemic disease) [Amr E. Abouleish et. al. 2015],&#xD;
  &#xD;
            -  Scheduled for elective cesarean section&#xD;
  &#xD;
            -  BMI: 18.5 - 35 kg/m2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  if they had American Society of Anaesthesiologists (ASA) status III and above (with&#xD;
               severe systemic disease),&#xD;
  &#xD;
            -  Patients with BMI &lt; 18.5 or &gt; 35 kg/m2 were excluded as they require a different&#xD;
               dosage of drug for spinal anesthesia,&#xD;
  &#xD;
            -  History of previous 2 Caesarian or more,&#xD;
  &#xD;
            -  Known allergy to the drug used (bupivacaine),&#xD;
  &#xD;
            -  Contraindication to NSAID: patients with suspected or manifest bleeding disturbances,&#xD;
               allergy to NSAID, atopia, bronchial asthma, diabetes mellitus, those who previously&#xD;
               had shown marked side effects after NSAID, the presence of liver or kidney disease,&#xD;
               abuse of drugs or alcohol, excessive smokers and patients with pregnancy induced&#xD;
               hypertension or pre-eclampsia&#xD;
  &#xD;
            -  Bleeding disorders, e.g.: thrombocytopenia,&#xD;
  &#xD;
            -  Neurological disorders associated with sensory alterations, e.g., Transverse myelitis&#xD;
               can cause back pain, abnormal sensations in the trunk and genital region and legs such&#xD;
               as sensory loss or paresthesias (abnormal sensations such as burning, tickling,&#xD;
               pricking, numbness, coldness, or tingling).&#xD;
  &#xD;
            -  Rheumatological diseases e.g., primary Sjögren's syndrome (pSS), systemic lupus&#xD;
               erythematosus (SLE) and rheumatoid arthritis (RA), accompanied by chronic widespread&#xD;
               pain due to arthralgia, myalgia or serositis.&#xD;
  &#xD;
            -  Requiring general anesthesia,&#xD;
  &#xD;
            -  if vertical abdominal incision was required,&#xD;
  &#xD;
            -  Local infection at the site of injection or&#xD;
  &#xD;
            -  The inability to provide a pain score, e.g., visual impairement.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed M. Maged, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Professor of Obstetrics and Gynecology at Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Salma A. Abdelhady, Resident</last_name>
      <phone>00201064328392</phone>
      <email>salma.abdelrahman@residents.kasralainy.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohamed A. Hamza, Lecturer</last_name>
      <phone>00201007100166</phone>
      <email>dr.hamza.mh@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Obstetrics and Gynecology department of Kasr Alainy University Hospital</name>
        <address>
          <city>Cairo</city>
          <state>El Manial</state>
          <zip>11562</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
      <investigator_title>Professor of Obstetrics and Gynecology at Cairo University</investigator_title>
    </responsible_party>
    <keyword>surgical rectus sheath block</keyword>
    <keyword>sudermal infiltration of local anaesthesia</keyword>
    <keyword>cesarean section</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
      <mesh_term>Anesthetics, Local</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020196
  org study id: 71
  nct id: NCT06020196
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  All participants will receive spinal anaesthesia and will be randomly divided into 2 equal
        groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to
        the rectus sheath space under direct vision before closure of the anterior abdominal wall.
        Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution
        before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25%
        Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.
  All participants will receive spinal anaesthesia and will be randomly divided into 2 equal
        groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to
        the rectus sheath space under direct vision before closure of the anterior abdominal wall.
        Meanwhile, Group II will receive subdermal injections of 20 ml of local anesthetic solution
        before closure of the skin. Each 20 ml of local anaesthetic solution contained 0.25%
        Bupivacaine (50 mg/ 20 ml), 4mg dexamethazone and 1:200,000 epinephrine.
  
        All cases will be followed up hourly for 6 hours postoperative for assessment of level of
        pain by using visual analog scale (VAS). Primary outcome parameters were VAS score during
        rest and the need for additional analgesics during the first 48 post-operative hours. Other
        parameters will be time of start of lactation and ambulation, length of post-operative
        hospital stay, and occurrence of side effects or complications.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study will be a prospective, single-blinded, randomized controlled trial (RCT) that include 182 patients scheduled for an elective lower segment Cesarean section at the Obstetrics and Gynecology department of Kasr Alainy University Hospital from April 2023 to August 2023.
  After obtaining approval from the hospital's institutional review board, we assessed 182 young women scheduled for an elective lower segment Cesarean section to determine their eligibility for the study.
  The182 patients admitted to be enrolled in our study, in which they're randomized into 2 groups, Group 1(n= 91) received bilateral surgical rectus sheath block and Group 2 (n =91) received subdermal infiltration of local anaesthetics.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: postoperative pain during rest
  time frame: 6 hours
  description: All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS)
  measure: the amount of additional analgesics consumption post-operatively for pain relief.
  time frame: 48 hours
  description: assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic
  measure: time of start of lactation
  time frame: 24 hours
  description: the interval between skin closure and the time the patient first breastfeeds her newborn.
  measure: time of start of ambulation
  time frame: 24 hours
  description: the interval between skin closure and the time patient first ambulated.
  measure: length of post-operative hospital stay
  time frame: 24 hours
  description: the interval between skin closure and the time patient discharged from hospital.
  measure: development of of side effects or complications.
  time frame: 24 hours
  description: The patient was observed for potential complications of RSB:
  The superior and inferior epigastric arteries are at risk of injury Visceral damage, Local anesthetic systemic toxicity, leading to seizures or ventricular arrhythmias (rare) Incomplete block may result from anatomical variance, as in up to 30% of the population.
  Failure of the block as the posterior wall of the rectus sheath lying superficial to the peritoneal cavity, needle misplacement may lead to injection into the peritoneal cavity.
  Infection.
  The patient was observed for potential complications of subdermal local anesthetic infilteration, including wound infection
  also the paients were observed for developemt of NSAID side effec
  arm group label: Rectus sheath block group
  arm group type: Active Comparator
  description: The participants will receive bilateral surgical rectus sheath block
  arm group label: Subdermal group
  arm group type: Active Comparator
  description: The participants will receive subdermal infiltration of local anaesthetics.
  intervention type: Procedure
  intervention name: surgical rectus sheath block
  description: Local anaesthetic will be administered into the rectus sheath space by the surgeon, towards the end of the operation, at the time of closure of the anterior abdominal wall (before the closure of peritoneum)
  arm group label: Rectus sheath block group
  intervention type: Procedure
  intervention name: subdermal local anaesthetic infiltration
  description: After closure of the subcutaneous fat, the edges of the skin become more stable; subdermal Infiltration with moving needle technique was done to optimize distribution of the local anesthetic solution
  arm group label: Subdermal group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed M. Maged, Professor
  role: Study Chair
  affiliation: Professor of Obstetrics and Gynecology at Cairo University
  last name: Salma A. Abdelhady, Resident
  phone: 00201064328392
  email: salma.abdelrahman@residents.kasralainy.edu.eg
  last name: Mohamed A. Hamza, Lecturer
  phone: 00201007100166
  email: dr.hamza.mh@gmail.com
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Cairo University
  investigator full name: Ahmed M Maged, MD
  investigator title: Professor of Obstetrics and Gynecology at Cairo University
  mesh term: Pain, Postoperative
  mesh term: Anesthetics
  mesh term: Anesthetics, Local
  sharing ipd: No