The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: surgical rectus sheath block; Procedure: subdermal local anaesthetic infiltration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salma A. Abdelhady, Resident; Phone Number: 00201064328392; Email: salma.abdelrahman@residents.kasralainy.edu.eg
• Study Contact Backup: Name: Mohamed A. Hamza, Lecturer; Phone Number: 00201007100166; Email: dr.hamza.mh@gmail.com

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11562
      • The Obstetrics and Gynecology department of Kasr Alainy University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women with singleton pregnancies.
• Gestational age 37 to 41 weeks.
• Surgical history: no history of previous surgeries or history of previous 1 cesarean section,
• Age: 20 -35 years old,
• American Society of Anesthesiologists physical status classifications II (healthy pregnancy or with mild systemic disease) [Amr E. Abouleish et. al. 2015],
• Scheduled for elective cesarean section
• BMI: 18.5 - 35 kg/m2.

Exclusion Criteria:

• if they had American Society of Anaesthesiologists (ASA) status III and above (with severe systemic disease),
• Patients with BMI < 18.5 or > 35 kg/m2 were excluded as they require a different dosage of drug for spinal anesthesia,
• History of previous 2 Caesarian or more,
• Known allergy to the drug used (bupivacaine),
• Contraindication to NSAID: patients with suspected or manifest bleeding disturbances, allergy to NSAID, atopia, bronchial asthma, diabetes mellitus, those who previously had shown marked side effects after NSAID, the presence of liver or kidney disease, abuse of drugs or alcohol, excessive smokers and patients with pregnancy induced hypertension or pre-eclampsia
• Bleeding disorders, e.g.: thrombocytopenia,
• Neurological disorders associated with sensory alterations, e.g., Transverse myelitis can cause back pain, abnormal sensations in the trunk and genital region and legs such as sensory loss or paresthesias (abnormal sensations such as burning, tickling, pricking, numbness, coldness, or tingling).
• Rheumatological diseases e.g., primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), accompanied by chronic widespread pain due to arthralgia, myalgia or serositis.
• Requiring general anesthesia,
• if vertical abdominal incision was required,
• Local infection at the site of injection or
• The inability to provide a pain score, e.g., visual impairement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rectus sheath block group; The participants will receive bilateral surgical rectus sheath block	Procedure: surgical rectus sheath block; 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)
Active Comparator: Subdermal group; The participants will receive subdermal infiltration of local anaesthetics.	Procedure: subdermal local anaesthetic infiltration; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain during rest	All cases will be followed up hourly for 6 hours postoperative for assessment of level of pain by using visual analog scale (VAS)	6 hours
the amount of additional analgesics consumption post-operatively for pain relief.	assessment amount of intravenous analgesic consumption during hospital stay. Also, an investigator contacted them 24 hours after discharge to monitor oral analgesic analgesic	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of start of lactation	the interval between skin closure and the time the patient first breastfeeds her newborn.	24 hours
time of start of ambulation	the interval between skin closure and the time patient first ambulated.	24 hours
length of post-operative hospital stay	the interval between skin closure and the time patient discharged from hospital.	24 hours
development of of side effects or complications.	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	24 hours

Collaborators and Investigators

• Sponsor: Ahmed M Maged, MD
• Investigators: Study Chair: Ahmed M. Maged, Professor, Professor of Obstetrics and Gynecology at Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cesarean section; surgical rectus sheath block; sudermal infiltration of local anaesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No