Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.
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Intervention Type: Combination Product, Drug
Study Type: Interventional
Study Phase: Phase 2
Study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery.
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: No
• provision to sign and date the consent form.
• stated willingness to comply with all study procedures and be available for the duration of the study.
• Male and female patients aged 18 and older
• Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a hybrid (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy
Rocky Mountain Regional VA Medical Center
University of Colorado Hospital
Highlands Ranch Hospital
Start Date:April 19, 2022
Estimated Completion Date:February 12, 2024
Target number of participants:110
Experimental: Investigational Arm
The study drug volume, concentration, and dose of treatment arm #1 selected is based on the Principal Investigator's prior experience recommendations by the Food Drug Administration (FDA), and evidence based on prior literature. The final concentration of ropivacaine is 0.375% and final volume of the mixture is 60mL.~Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg)~Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug)~Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg)~Normal saline 0.9%, 18.5mL
Active Comparator: Liposomal Bupivacaine (Exparel)
The study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows:~Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg)~Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms).