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

Sponsor

Ahmed M Maged, MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06020196

Collaborator

(none)

182

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: surgical rectus sheath block Procedure: subdermal local anaesthetic infiltration	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

182 participants

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.