Status:
WITHDRAWN
Transverse Abdominus Plane Block Study
Lead Sponsor:
University of Colorado, Denver
Conditions:
Colorectal Disorders
Surgery
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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®) ...
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, dex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05216055
Start Date
April 19 2022
End Date
December 27 2022
Last Update
March 6 2023
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