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Clinical trial

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.

ID
Name
20-2574.cc
Description
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.
Trial arms
Trial start
2022-04-19
Estimated PCD
2022-12-16
Trial end
2022-12-27
Status
Withdrawn
Phase
Early phase I
Treatment
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
Arms:
Investigational Arm
Liposomal bupivacaine
Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL
Arms:
Liposomal Bupivacaine (Exparel)
Other names:
Exparel
Primary endpoint
Post-operative opioid consumption in the first 72 hours
72 hours
Post-operative opioid consumption over hospital stay
2 months
Visual analog scale pain scores in the PACU
72 hours
Visual analog scale pain scores 12 hours post op
12 hours
Visual analog scale pain scores 24 hours post op
24 hours
Visual analog scale pain scores 36 hours post op
36 hours
Visual analog scale pain scores 48 hours post op
48 hours
Visual analog scale pain scores 72 hours post op
72 hours
Epidural need
2 months
Need for postoperative patient-controlled analgesia (PCA)
72 hours
Need for adjunctive systemic nonopioid pain medications
2 months
Prescribed opioid at discharge
2 months
Outpatient narcotic refill
2 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-03-06

1 organization

2 products

2 indications

Organization
University of Colorado Denver
Product
Ropivacaine
Indication
Colorectal Disorders
Indication
Surgery
Product
Liposomal bupivacaine