Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 12, 2007
July 29, 2009
December 2007
September 2008   (final data collection date for primary outcome measure)
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00573963 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: ropivacaine
    2 injections of 20mL 0.375% ropivacaine - one given on each side.
    Other Name: Naropin
  • Drug: saline solution
    2 injections of 20mL plain saline solution - one on each side.
  • Active Comparator: 1
    Ropivacaine
    Intervention: Drug: ropivacaine
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2008
September 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00573963
07-11, 07-0245-A
No
Dr. Jose C.A. Carvalho, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP