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

NCT ID: NCT06324942

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-19
• Study Completion Date: 2026-12-31

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.

Conditions

Cesarean Section Complications; Pain, Postoperative

Study Design

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

Study Groups

Surgeon-administered Transversus Abdominis Plane Block (TAP block)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Surgeon-administered Transversus Abdominis Plane Block

No TAP block

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Surgeon-administered Transversus Abdominis Plane Block

Intervention Type: OTHER

Other Intervention Names

TAP block

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Stephen Wood

Dr Stephen Wood

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Wood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stephen Wood, MD

Role: CONTACT

slwood@ucalgary.ca

4039441438

Facility Contacts

Stephen Wood, MD

Role: primary

stephen.wood@albertahealthservices.ca

403-944-1438

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REB24-0349

Identifier Type: -

Identifier Source: org_study_id