An interventional study of TAP Block Group in Post-operative Pain, sponsored by University of Massachusetts, Worcester. Withdrawn. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment
The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
Browse Pain, Postoperative studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exclusion Criteria:
Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.
Procedure: TAP Block Group
Participants will not receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery and will receive the routine standard of care for post-operative pain control.
Participants will receive a surgeon administered TAP block.
Daily Narcotic Use in Morphine Equivalents
Daily Narcotic Use in Morphine Equivalents
Time frame: From time of surgery through postpartum day 4
Time to first administered narcotic (oral or parental)
Time to first administered narcotic (oral or parental) post cesarean delivery
Time frame: From time of surgery through postpartum day 4
Daily Average Pain Score
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Time frame: From time of surgery through postpartum day 4
Daily Maximum Pain Score
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
Time frame: From time of surgery through postpartum day 4
Time to First Ambulation
Time to First Ambulation post cesarean delivery
Time frame: From time of surgery through postpartum day 4
Time to First Solid Food
Time to First Solid Food
Time frame: From time of surgery through postpartum day 4
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester