Clinical trial NCT05216055: Transverse Abdominus Plane Block Study
Official title: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Colorectal Disorders
Surgery
Keywords: Benign
Malignant
Laparoscopic Surgery
Robotic Surgery
Hybrid Surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Post-operative opioid consumption in the first 72 hours
timeFrame: 72 hours
measure: Post-operative opioid consumption over hospital stay
timeFrame: 2 months
measure: Visual analog scale pain scores in the PACU
timeFrame: 72 hours
measure: Visual analog scale pain scores 12 hours post op
timeFrame: 12 hours
measure: Visual analog scale pain scores 24 hours post op
timeFrame: 24 hours
measure: Visual analog scale pain scores 36 hours post op
timeFrame: 36 hours
measure: Visual analog scale pain scores 48 hours post op
timeFrame: 48 hours
measure: Visual analog scale pain scores 72 hours post op
timeFrame: 72 hours
measure: Epidural need
timeFrame: 2 months
measure: Need for postoperative patient-controlled analgesia (PCA)
timeFrame: 72 hours
measure: Need for adjunctive systemic nonopioid pain medications
timeFrame: 2 months
measure: Prescribed opioid at discharge
timeFrame: 2 months
measure: Outpatient narcotic refill
timeFrame: 2 months
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 2 months
measure: Use of antiemetics in the first 12 hours post op
timeFrame: 12 hours
measure: Use of antiemetics in the first 24 hours post op
timeFrame: 24 hours
measure: Use of antiemetics in the first 36 hours post op
timeFrame: 36 hours
measure: Use of antiemetics in the first 48 hours post op
timeFrame: 48 hours
measure: Use of antiemetics in the first 72 hours post op
timeFrame: 72 hours
measure: Time to first flatus
timeFrame: 2 months
measure: Time to first bowel movement
timeFrame: 2 months
measure: Need to insert nasogastric tube
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Brandon C Chapman
role: PRINCIPAL_INVESTIGATOR
References: