Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: saline solution; Drug: ropivacaine

• Registration Number: NCT00573963
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.

Detailed Description

A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive an injection of local anesthetic on either side of their abdomen, into the plane of the transversus abdominis muscle. We are also interested in whether or not this injection decreases the need for other pain-killing medication during this time.

Patients will randomly be assigned to receive either local anesthetic or a placebo. In addition, all patients will receive the usual standard of care and medication for pain. At 6, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The risk of side effects is very low, as the block is done in an area with low blood supply. We propose that the addition of the TAP block to the current multi-modal regimen of post-cesarean pain management will reduce pain scores and requests for additional analgesia post-operatively, as well as increase patient satisfaction with their pain control.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-14
• Primary Completion: 2008-09
• Study Completion: 2008-11
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-29
• Last Update Posted: 2009-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women undergoing elective cesarean delivery

Read More

Exclusion Criteria

• Patients unable to communicate in English
• Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
• Patients with contraindications to spinal anesthesia
• Patients with an allergy to ropivacaine, morphine, ketorolac or acetaminophen
• Patients who have taken any pain medication in the past 24 hours
• Patients with a BMI > 40

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	saline solution	Placebo
1	ropivacaine	Ropivacaine

Primary Outcome Measures

Name	Time	Method
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.	24 hours

Secondary Outcome Measures

Name	Time	Method
Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively.	48 hours
Opioid consumption at 6, 12, 24 & 48 hours postoperatively.	48 hours
Time to first maternal request for supplemental analgesia.	48 hours
Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively.	48 hours
Presence of pain 6 weeks postoperatively.	6 weeks

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada