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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Cesarean Section Complications
• Intervention / Treatment: Other: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Wood, MD; Phone Number: 4039441438; Email: slwood@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg; Surgeon-administered Transversus Abdominis Plane Block; Other Names: TAP block
No Intervention: No TAP block; A sham procedure will not be performed but the patient will be unaware of whether or not an injection was done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Pain	VAS scale 0-no pain to 10-worst pain	12 hours post op

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: REB24-0349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No