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

NCT ID: NCT03149783

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-13
• Study Completion Date: 2021-10-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine

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

Group Type: EXPERIMENTAL

Ropivacaine HCL

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

sodium chloride

Intervention Type: DRUG

Placebo

Interventions

Ropivacaine HCL

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

Intervention Type: DRUG

sodium chloride

Placebo

Intervention Type: DRUG

Other Intervention Names

saline

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Denver Veterans Affairs Medical Center

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Douglas Overbey, MD

Role: CONTACT

douglas.overbey@ucdenver.edu

573-225-7728

Thomas Robinson, MD

Role: CONTACT

thomas.robinson@ucdenver.edu

303-399-8020 Ext. 2952

Facility Contacts

Thomas Robinson, MD

Role: primary

thomas.robinson@ucdenver.edu

303-399-8020 ext. 2952

Douglas Overbey, MD

Role: backup

douglas.overbey@ucdenver.edu

573-225-7728

Other Identifiers

16-1078

Identifier Type: -

Identifier Source: org_study_id