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

NCT06324942 | Recruiting

• 1 other identifier: REB24-0349
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Post operative Pain

  VAS scale 0-no pain to 10-worst pain

  12 hours post op

Secondary Outcomes (3)

• Time to first request for rescue analgesia in hours

  48 hours post op

• Post operative Opioid use

  up to 48 hours post op.

• Time from surgery to discharge from hospital

  Up to discharge from hospital, usually 1-3 days

Study Arms (2)

Surgeon-administered Transversus Abdominis Plane Block (TAP block)

EXPERIMENTAL

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.

Other: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg

No TAP block

NO INTERVENTION

A sham procedure will not be performed but the patient will be unaware of whether or not an injection was done.

Interventions

Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg OTHER

Surgeon-administered Transversus Abdominis Plane Block

Also known as: TAP block

Surgeon-administered Transversus Abdominis Plane Block (TAP block)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

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

• Stephen Wood, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Wood, MD

CONTACT

4039441438; slwood@ucalgary.ca

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: PRINCIPAL INVESTIGATOR
• PI Title: Dr Stephen Wood

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 22, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)