This phase II trial tests whether the transversus abdominus plane (TAP) block mixture (ropivacaine, dexamethasone, and dexmedetomidine) or liposomal bupivacaine works to improve pain control following surgery of the colon and the rectum. Opioids (i.e., narcotics, pain killers) are known to have side effects including nausea, vomiting, increased sleepiness (sedation), decreased breathing (respiratory suppression), slowing down the intestines (ileus), and may lead to long-term use of opioids. Transversus abdominus plane (TAP) blocks are commonly used to control pain following surgery of the colon and the rectum and may reduce the amount of opioids needed after surgery. This may help researchers learn more about improving pain control following surgery of the colon and rectum.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05216055.
PRIMARY OBJECTIVE:
I. To examine the effect of laparoscopic guided transversus abdominus plane (TAP) blocks and dual-adjunct therapy on post-operative opioid consumption following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum.
SECONDARY OBJECTIVES:
I. 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.
II. 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.
III. To assess the safety of laparoscopic guided TAP blocks and dual-adjunct therapy in the perioperative period following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum.
IV. To evaluate the costs differences between laparoscopic guided TAP blocks with dual-adjunct therapy and liposomal bupivacaine following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive TAP block mixture with ropivacaine, dexamethasone, and dexmedetomidine via injection during surgery.
ARM II: Patients receive liposomal bupivacaine via injection during surgery.
After completion of study treatment, patients are followed up at 1-2 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorBrandon Chapman
