Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section

Not Applicable

Completed

• Conditions: Analgesia

• Registration Number: NCT05136118
• Lead Sponsor: Ain Shams University

Brief Summary

Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.

Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.

Detailed Description

Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.

Study Timeline

• Study First Submitted: 2021-10-08
• Study Start: 2021-11-01
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-11-29
• Primary Completion: 2022-08-30
• Status Verified: 2022-10
• Study Completion: 2022-10-25
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

• ASA physical status I and ∏
• primigravidas
• aged 21-40 years
• BMI ˂ 40
• body weight ˃ 60 kg
• singleton pregnancy
• gestational age of ≥37 weeks
• undergoing elective caesarean section under spinal anesthesia.

Exclusion Criteria

• Parturient refusal
• parturient with a BMI > 40
• body weight < 60 kg
• ASA physical status ≥ III
• known local anesthetic (LA) allergy •contraindications to spinal anesthesia
• parturients who received analgesics in the past 24 hours
• infection at the site of the block.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to rescue analgesia	6 months	the time from the end of surgery until the first parturient's request for analgesia

Secondary Outcome Measures

Name	Time	Method
Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia	6 months	assessment of pain intensity at rest and on passive flexion of the hip and knee by the Numeric Pain Rating Score (NPRS) from 0 = no pain to 10 = worst pain. Assessment will be done at 2, 6, 12 and 24h postoperative.
Number of parturients requiring postoperative analgesia	6 months	defined as pethidine needed by each parturient in the 24 hours postoperative period
Total dose of pethidine given	6 months	defined as pethidine needed by each parturient in the 24 hours postoperative period
Time to the parturient's first ambulation	6 months	the time to start of each parturient movement in the 24 hours postoperative period
The analgesic satisfaction 24 hours after operation	6 months	parturients will be asked to report their satisfaction with pain management, assessed as 0 = weak, 1 = medium, 2 = good, 3 = very good, and 4 = excellent.

Trial Locations

Locations (1)

Ain-Shams University; 🇪🇬 Cairo, Egypt