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

NCT03149783 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 16-1078
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain scores from the visual analog scale

  Days 0-7 following the operation

Secondary Outcomes (2)

• Amount of anesthetic

  During the operation

• Amount of narcotic administered postoperatively

  Days 0-7 postop

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine.

Drug: Ropivacaine HCL

Placebo

PLACEBO COMPARATOR

Participants will have bilateral TAP catheters placed along with continuous infusion of placebo.

Drug: sodium chloride

Interventions

Ropivacaine HCL DRUG

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

Ropivacaine

sodium chloride DRUG

Placebo

Also known as: saline

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Denver Veterans Affairs Medical Center

Denver, Colorado, 80221, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Delirium

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thomas Robinson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas Overbey, MD

CONTACT

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

Thomas Robinson, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: "Study drug" label of drug
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Double Blind Trial

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: May 11, 2017
• Study Start: February 13, 2018
• Primary Completion: August 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)