Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia
|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.|
- Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||December 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
2 injections of 20mL 0.375% ropivacaine - one given on each side.
Other Name: Naropin
Placebo Comparator: 2
Drug: saline solution
2 injections of 20mL plain saline solution - one on each side.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573963
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Jose CA Carvalho, MD||Mount Sinai Hospital, New York|