Transverse Abdominus Plane Block Study

Phase 2

Withdrawn

• Conditions: Surgery; Colorectal Disorders
• Interventions: Combination Product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline; Drug: Liposomal bupivacaine

• Registration Number: NCT05216055
• Lead Sponsor: University of Colorado, Denver

Brief 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.

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 Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-31
• Study Start: 2022-04-19
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Arm	Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline	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. 1. Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg) 2. Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug) 3. Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg) 4. Normal saline 0.9%, 18.5mL
Liposomal Bupivacaine (Exparel)	Liposomal bupivacaine	The study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows: 1. Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) 2. Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Use of antiemetics in the first 24 hours post op	24 hours	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.
Use of antiemetics in the first 48 hours post op	48 hours	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.
Need to insert nasogastric tube	2 months	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.
Length of hospital stay	2 months	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
Use of antiemetics in the first 36 hours post op	36 hours	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.
Use of antiemetics in the first 72 hours post op	72 hours	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.
Time to first flatus	2 months	Days from surgery to first flatus postoperatively. Reviewed using the EMR.
Use of antiemetics in the first 12 hours post op	12 hours	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.
Time to first bowel movement	2 months	Days from surgery to first bowel movement postoperatively. Reviewed using the EMR.