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

NCT ID: NCT06020196

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-04-30

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.

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.

Conditions

Post Operative Pain

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rectus sheath block group

The participants will receive bilateral surgical rectus sheath block

Group Type: ACTIVE_COMPARATOR

surgical rectus sheath block

Intervention Type: 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)

Subdermal group

The participants will receive subdermal infiltration of local anaesthetics.

Group Type: ACTIVE_COMPARATOR

subdermal local anaesthetic infiltration

Intervention Type: 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

Interventions

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)

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ahmed M Maged, MD

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

Professor of Obstetrics and Gynecology at Cairo University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmed M. Maged, Professor

Role: STUDY_CHAIR

Professor of Obstetrics and Gynecology at Cairo University

Locations

The Obstetrics and Gynecology department of Kasr Alainy University Hospital

Cairo, El Manial, Egypt

Countries

Egypt

Central Contacts

Salma A. Abdelhady, Resident

Role: CONTACT

Phone: 00201064328392

Email: salma.abdelrahman@residents.kasralainy.edu.eg

Mohamed A. Hamza, Lecturer

Role: CONTACT

Phone: 00201007100166

Email: dr.hamza.mh@gmail.com

Other Identifiers

71

Identifier Type: -

Identifier Source: org_study_id