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

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00573963
First received: December 12, 2007
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Pain
Drug: ropivacaine
Drug: saline solution

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

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Opioid consumption at 6, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Time to first maternal request for supplemental analgesia. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Presence of pain 6 weeks postoperatively. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ropivacaine
Drug: ropivacaine
2 injections of 20mL 0.375% ropivacaine - one given on each side.
Other Name: Naropin
Placebo Comparator: 2
Placebo
Drug: saline solution
2 injections of 20mL plain saline solution - one on each side.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573963

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00573963     History of Changes
Other Study ID Numbers: 07-11, 07-0245-A
Study First Received: December 12, 2007
Last Updated: July 29, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cesarean section

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014