Transverse Abdominus Plane Block Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Colorectal Disorders, Surgery

Intervention / Treatment
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* Combination Product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline
* Drug: Liposomal bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Arm<br>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<br>* 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<br>|
| Active Comparator: Liposomal Bupivacaine (Exparel)<br>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<br>* Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL<br>* Other names: Exparel;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign, Malignant, Laparoscopic Surgery, Robotic Surgery, Hybrid Surgery