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Dual-Adjunct TAP Block vs Exparel in Colorectal Surgery
NCT05216055Phase 2
Key facts
- Status
- Withdrawn
- Start
- Apr 2022
- Primary completion
- Dec 2022
- Sponsor
- University of Colorado Denver
- Modality
- Orthosteric Ligands
- Conditions
- postoperative pain
01
Overview
Phase 2, randomised, single-blind trial of dexmedetomidine and dexamethasone in postoperative pain (2 arms), sponsored by University of Colorado Denver. Primary endpoints: Post-operative opioid consumption in the first 72 hours, Post-operative opioid consumption over hospital stay at 2 months and 6 more. Planned start Apr 2022; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Investigational Arm
TAP block with Ropivacaine + Dexmedetomidine + Dexamethasone
Liposomal Bupivacaine (Exparel)
TAP block with Liposomal Bupivacaine + Bupivacaine
03
Who it enrols
Adult patients undergoing elective minimally invasive colorectal resection (laparoscopic, robotic, or hybrid) for benign or malignant disease. Excludes pregnant/breastfeeding patients, those with opioid dependence, incarcerated individuals, and urgent/emergent operations.
04
Endpoints
Primary
Post-operative opioid consumption in the first 72 hours
Post-operative opioid consumption over hospital stay
Visual analog scale pain scores
Epidural need
Need for postoperative patient-controlled analgesia (PCA)
Secondary
Length of hospital stay
Use of antiemetics
Time to first flatus
Time to first bowel movement
Need to insert nasogastric tube
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