Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores

Overview

A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores. This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.

Full Title of Study: “A Randomized Controlled Trial to Determine if Pre- and Post- Operative Regional Pain Control (Transversus Abdominis Plane Block) With Ropivacaine Versus Placebo Leads to Lower Anesthetic and Narcotic Dosing, and Alters Pain Scores”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2021

Interventions

  • Drug: Ropivacaine HCL
    • Ropivacaine injected after placement of catheters, then infused during the operation
  • Drug: sodium chloride
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Ropivacaine
    • Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine.
  • Placebo Comparator: Placebo
    • Participants will have bilateral TAP catheters placed along with continuous infusion of placebo.

Clinical Trial Outcome Measures

Primary Measures

  • Pain Scores
    • Time Frame: Days 0-7 following the operation
    • Pain scores from the visual analog scale

Secondary Measures

  • Amount of anesthetic
    • Time Frame: During the operation
    • MAC of inhalational agent, or total amount of IV anesthetic used during the operation
  • Amount of narcotic administered postoperatively
    • Time Frame: Days 0-7 postop
    • Amount of morphine equivalents per day measured after the operation

Participating in This Clinical Trial

Inclusion Criteria

  • Age >=50 years. – Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery. Exclusion Criteria:

  • Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable. – Patients with an epidural or spinal catheter block. – Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion. – Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded. – History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia). – Patients with a documented allergy to ropivacaine or other sodium channel blockers.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Robinson, MD, Principal Investigator, University of Colorado, Denver
  • Overall Contact(s)
    • Douglas Overbey, MD, 573-225-7728, douglas.overbey@ucdenver.edu

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