Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Cesarean Section Complications
• Interventions: Other: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg

• Registration Number: NCT06324942
• Lead Sponsor: University of Calgary

Brief Summary

The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.

Detailed Description

Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Study Start: 2024-06
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• ASA status II to III
• All patients undergoing elective CS under regional anesthesia at any gestational age.

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Exclusion Criteria

• • Known drug allergy to local anesthetics
• Planned general anesthetic
• NSAID use contraindicated post partum
• Chronic pain disorder or chronic narcotic use/dependence
• Planned vertical abdominal incision
• Planned Cesarean Hysterectomy.
• Placenta Previa or suspected Placenta Accreta

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgeon-administered Transversus Abdominis Plane Block (TAP block)	Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg	After uterine closure, the anterior abdominal wall on the contralateral side to the surgeon is elevated and retracted laterally by an assistant. The bowel and uterus is retracted using the surgeon's non-dominant hand, with or without a sponge. Under direct visualization, a blunted spinal needle is inserted lateral to the rectus muscle to avoid injury to inferior epigastric blood vessels. The needle is then gently advanced through the transversus abdominis fascia into the TAP plane, identified at loss of resistance, or 'a pop'. After aspiration to confirm no accidental placement of the needle intravascularly, local anaesthetic is infiltrated into the transverse abdominis plane through the parietal peritoneum by the surgeon at a prespecified dose of 0.25% bupivicaine 0.25 mL/kg (approximately 20cc). This is repeated on the contralateral side, after which closure of the fascia, subcutaneous tissue, and skin were performed.

Primary Outcome Measures

Name	Time	Method
Post operative Pain	12 hours post op	VAS scale 0-no pain to 10-worst pain

Secondary Outcome Measures

Name	Time	Method
Post operative Opioid use	up to 48 hours post op.	Total opioid consumption in the first 24h and 48h mark, postoperatively
Time to first request for rescue analgesia in hours	48 hours post op	Time from completion of surgery to first request for rescue analgesia in hours
Time from surgery to discharge from hospital	Up to discharge from hospital, usually 1-3 days	Time from completion of surgery to discharge

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada