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

Pain Clinical Trial

Official title:

Determination of the Efficay of the Transversus Abdominis Plane (TAP) Block as Part of a Multimodal Regimen for Post-cesarean Delivery Analgesia: a Double Blinded Placebo-controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573963
• Other study ID #: 07-11
• Secondary ID: 07-0245-A
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: July 29, 2009
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: July 2009
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women undergoing elective cesarean delivery

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ropivacaine
2 injections of 20mL 0.375% ropivacaine - one given on each side.
• saline solution
2 injections of 20mL plain saline solution - one on each side.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.		24 hours	No
Secondary	Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively.		48 hours	No
Secondary	Opioid consumption at 6, 12, 24 & 48 hours postoperatively.		48 hours	No
Secondary	Time to first maternal request for supplemental analgesia.		48 hours	No
Secondary	Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively.		48 hours	No
Secondary	Presence of pain 6 weeks postoperatively.		6 weeks	No