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.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination Product, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: No
View:

• 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

Locations
United States
Colorado
Rocky Mountain Regional VA Medical Center
Recruiting
Aurora
University of Colorado Hospital
Recruiting
Aurora
Highlands Ranch Hospital
Recruiting
Highlands Ranch
Contact Information
Primary
Tracey MacDermott
tracey.macdermott@cuanschutz.edu
13037242757
Backup
Samuel Lai
410-676-8549
Time Frame
Start Date: April 19, 2022
Estimated Completion Date: February 12, 2024
Participants
Target number of participants: 110
Treatments
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).
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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