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

NCT06020196 | Unknown DMC

• 1 other identifier: 71
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

surgical rectus sheath block; sudermal infiltration of local anaesthesia; cesarean section

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• time of start of lactation

  24 hours

• time of start of ambulation

  24 hours

• length of post-operative hospital stay

  24 hours

• development of of side effects or complications.

  24 hours

Study Arms (2)

Rectus sheath block group

ACTIVE COMPARATOR

The participants will receive bilateral surgical rectus sheath block

Procedure: surgical rectus sheath block

Subdermal group

ACTIVE COMPARATOR

The participants will receive subdermal infiltration of local anaesthetics.

Procedure: subdermal local anaesthetic infiltration

Interventions

surgical rectus sheath block PROCEDURE

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)

Rectus sheath block group

subdermal local anaesthetic infiltration PROCEDURE

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

Subdermal group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed M Maged, MD: lead

Study Sites (1)

The Obstetrics and Gynecology department of Kasr Alainy University Hospital

Cairo, El Manial, 11562, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ahmed M. Maged, Professor

  Professor of Obstetrics and Gynecology at Cairo University

  STUDY CHAIR

Central Study Contacts

Salma A. Abdelhady, Resident

CONTACT

00201064328392; salma.abdelrahman@residents.kasralainy.edu.eg

Mohamed A. Hamza, Lecturer

CONTACT

00201007100166; dr.hamza.mh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology at Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)