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

Ahmed M Maged, MD

Status: Not yet enrolling

Conditions: Post Operative Pain

Treatments: Procedure: surgical rectus sheath block; Procedure: subdermal local anaesthetic infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT06020196

71

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups

Rectus sheath block group

Active Comparator group

Description:

The participants will receive bilateral surgical rectus sheath block

Treatment:

Procedure: surgical rectus sheath block

Subdermal group

Active Comparator group

Description:

The participants will receive subdermal infiltration of local anaesthetics.

Treatment:

Procedure: subdermal local anaesthetic infiltration