Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia
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|ClinicalTrials.gov Identifier: NCT00573963|
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : July 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: ropivacaine Drug: saline solution||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||November 2008|
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.
- Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. [ Time Frame: 24 hours ]
- Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 hours ]
- Opioid consumption at 6, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 hours ]
- Time to first maternal request for supplemental analgesia. [ Time Frame: 48 hours ]
- Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively. [ Time Frame: 48 hours ]
- Presence of pain 6 weeks postoperatively. [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573963
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Jose CA Carvalho, MD||Mount Sinai Hospital, New York|