Transverse Abdominus Plane Block Study (TAP)

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Surgery; Colorectal Disorders
• Intervention / Treatment: Combination product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline; Drug: Liposomal bupivacaine

Detailed Description

This is a non-inferiority single-blinded randomized trial aiming to 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. This study aims to continue improving our current hospital wide effort in reducing opioid consumption and, consequently, the acute and long-term consequences of opioids. It will also complement the current ongoing efforts of the Department of Surgery's quality and safety improvement project in opioid stewardship. Additionally, this dual adjunct TAP solution combination is inexpensive ($28 per injection) and may result in a significant cost savings for the hospital.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Tracey MacDermott; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu
      • Principal Investigator: Brandon Chapman
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Rocky Mountain Regional VA Medical Center
      • Contact: Tracey MacDermott; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu
      • Principal Investigator: Brandon Chapman
    • Highlands Ranch, Colorado, United States, 80129
      • Recruiting
      • Highlands Ranch Hospital
      • Contact: Tracey MacDermott; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant or breastfeeding patients
• Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
• Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
• Incarcerated individuals
• Age less than 18 years-old
• Urgent/emergent operations as defined by need for operation within 24 hours
• Other conditions or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
• Enrollment in another concurrent study with use of investigational drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Combination product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline; 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).	Drug: Liposomal bupivacaine; Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative opioid consumption in the first 72 hours	Total amount of both intravenous and oral opioid use in the first 72 hours after surgery measured in morphine milligram equivalents.	72 hours
Post-operative opioid consumption over hospital stay	Total morphine dose equivalents administered throughout hospital stay	2 months
Visual analog scale pain scores in the PACU	Visual analog scale (VAS) pain scores in the PACU	72 hours
Visual analog scale pain scores 12 hours post op	Visual analog scale pain scores 12 hours post op	12 hours
Visual analog scale pain scores 24 hours post op	Visual analog scale pain scores 24 hours post op	24 hours
Visual analog scale pain scores 36 hours post op	Visual analog scale pain scores 36 hours post op	36 hours
Visual analog scale pain scores 48 hours post op	Visual analog scale pain scores 48 hours post op	48 hours
Visual analog scale pain scores 72 hours post op	Visual analog scale pain scores 72 hours post op	72 hours
Epidural need	Need for an epidural post-operatively. Reviewed using the EMR.	2 months
Need for postoperative patient-controlled analgesia (PCA)	Determined by review of EMR. Patients use or non-use of PCA.	72 hours
Need for adjunctive systemic nonopioid pain medications	Adjunctive systemic nonopioid pain medications	2 months
Prescribed opioid at discharge	Amount of opioid prescribed at discharge	2 months
Outpatient narcotic refill	Use the EMR to determine outpatient narcotic refill	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on length of hospital stay following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Calculating the length of hospital stay will allow for evaluation of effectiveness of dual adjunct therapy in context of ERAS protocol compared to liposomal bupivacaine	2 months
Use of antiemetics in the first 12 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	12 hours
Use of antiemetics in the first 24 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	24 hours
Use of antiemetics in the first 36 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	36 hours
Use of antiemetics in the first 48 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	48 hours
Use of antiemetics in the first 72 hours post op	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.	72 hours
Time to first flatus	Days from surgery to first flatus postoperatively. Reviewed using the EMR.	2 months
Time to first bowel movement	Days from surgery to first bowel movement postoperatively. Reviewed using the EMR.	2 months
Need to insert nasogastric tube	To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Reviewed using the EMR.	2 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Brandon C Chapman, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Malignant; Benign; Robotic Surgery; Laparoscopic Surgery; Hybrid Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Dexmedetomidine; Bupivacaine; Ropivacaine; Dexamethasone 21-phosphate
• Other Study ID Numbers: 20-2574.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No