Recruiting
Phase 2

Transversus Abdominis Plane Block

Sponsor:

University of Colorado, Denver

Code:

NCT03149783

Conditions

Pain, Postoperative

Delirium

Anesthesia, Local

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Ropivacaine HCL

sodium chloride

Study Details

Brief summary:

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.

Conditions

Pain, Postoperative

Delirium

Anesthesia, Local

Study ID

NCT03149783

Start date

Feb 13, 2018

Status verified date

May, 2021

Completion date

Oct 31, 2021

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Ropivacaine HCL

Ropivacaine injected after placement of catheters, then infused during the operation

sodium chloride

Placebo

Primary outcome measure

  • Pain Scores [ Time Frame: Days 0-7 following the operation ]

Central Contacts and Locations

Central contacts

Douglas Overbey, MD

573-225-7728douglas.overbey@ucdenver.edu

Thomas Robinson, MD

303-399-8020 Ext. 2952thomas.robinson@ucdenver.edu

Locations

Denver Veterans Affairs Medical Center

Recruiting

Denver, Colorado, United States, 80221

Contacts

Thomas Robinson, MD

303-399-8020thomas.robinson@ucdenver.edu

Douglas Overbey, MD

573-225-7728douglas.overbey@ucdenver.edu

Principal Investigator:

Thomas N Robinson, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 27, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2021-05-27.