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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03149783

Acronym

TAP RCT

Enrollment

Registered

2017-05-11

Start date

2018-02-13

Completion date

2021-10-31

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Delirium, Anesthesia, Local

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.

Interventions

DRUGRopivacaine HCL

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

DRUGsodium chloride

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Study drug label of drug

Intervention model description

Randomized Controlled Double Blind Trial

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain Scores	Days 0-7 following the operation	Pain scores from the visual analog scale

Secondary

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

Countries

United States

Contacts

Primary ContactDouglas Overbey, MD

douglas.overbey@ucdenver.edu573-225-7728

Backup ContactThomas Robinson, MD

thomas.robinson@ucdenver.edu303-399-8020 Ext. 2952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026