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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- Visual analog scale pain scores 12 hours post op
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
This study is a randomized single blinded trial to minimize bias and provide highest level of evidence in use as part of effort to reduce opioid use consumption. This study cannot be performed as a double blinded RCT due to Exparel being milky white color in appearance and cannot be altered or shielded from being visible by the operating surgeon performing the TAP block.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline (Combination Product)
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).
Intervention: Liposomal bupivacaine (Drug)
Outcomes
Primary Outcomes
Visual analog scale pain scores 12 hours post op
Time Frame: 12 hours
Visual analog scale pain scores 12 hours post op
Prescribed opioid at discharge
Time Frame: 2 months
Amount of opioid prescribed at discharge
Visual analog scale pain scores 72 hours post op
Time Frame: 72 hours
Visual analog scale pain scores 72 hours post op
Outpatient narcotic refill
Time Frame: 2 months
Use the EMR to determine outpatient narcotic refill
Post-operative opioid consumption in the first 72 hours
Time Frame: 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
Time Frame: 24 hours
Visual analog scale pain scores 24 hours post op
Visual analog scale pain scores 48 hours post op
Time Frame: 48 hours
Visual analog scale pain scores 48 hours post op
Epidural need
Time Frame: 2 months
Need for an epidural post-operatively. Reviewed using the EMR.
Need for adjunctive systemic nonopioid pain medications
Time Frame: 2 months
Adjunctive systemic nonopioid pain medications
Need for postoperative patient-controlled analgesia (PCA)
Time Frame: 72 hours
Determined by review of EMR. Patients use or non-use of PCA.
Post-operative opioid consumption over hospital stay
Time Frame: 2 months
Total morphine dose equivalents administered throughout hospital stay
Visual analog scale pain scores in the PACU
Time Frame: 72 hours
Visual analog scale (VAS) pain scores in the PACU
Visual analog scale pain scores 36 hours post op
Time Frame: 36 hours
Visual analog scale pain scores 36 hours post op
Secondary Outcomes
- Use of antiemetics in the first 24 hours post op(24 hours)
- Use of antiemetics in the first 48 hours post op(48 hours)
- Need to insert nasogastric tube(2 months)
- Length of hospital stay(2 months)
- Use of antiemetics in the first 36 hours post op(36 hours)
- Use of antiemetics in the first 72 hours post op(72 hours)
- Time to first flatus(2 months)
- Use of antiemetics in the first 12 hours post op(12 hours)
- Time to first bowel movement(2 months)