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

Primary Purpose

Pain, Postoperative, Delirium, Anesthesia, Local

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ropivacaine HCL

sodium chloride

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Denver Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Scores

Pain scores from the visual analog scale

Secondary Outcome Measures

Amount of anesthetic

MAC of inhalational agent, or total amount of IV anesthetic used during the operation

Amount of narcotic administered postoperatively

Amount of morphine equivalents per day measured after the operation

Full Information

NCT ID

NCT03149783

First Posted

March 10, 2017

Last Updated

May 26, 2021

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT03149783

Brief Title

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

Acronym

TAP RCT

Official Title

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

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 13, 2018 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Delirium, Anesthesia, Local

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Double Blind Trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

"Study drug" label of drug

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ropivacaine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ropivacaine HCL

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sodium chloride

Other Intervention Name(s)

saline

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Pain Scores

Description

Pain scores from the visual analog scale

Time Frame

Days 0-7 following the operation

Secondary Outcome Measure Information:

Title

Amount of anesthetic

Description

MAC of inhalational agent, or total amount of IV anesthetic used during the operation

Time Frame

During the operation

Title

Amount of narcotic administered postoperatively

Description

Amount of morphine equivalents per day measured after the operation

Time Frame

Days 0-7 postop

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Douglas Overbey, MD

Phone

573-225-7728

douglas.overbey@ucdenver.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Robinson, MD

Phone

303-399-8020 Ext. 2952

thomas.robinson@ucdenver.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Robinson, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Denver Veterans Affairs Medical Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80221

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Robinson, MD

Phone

303-399-8020

Ext

2952

thomas.robinson@ucdenver.edu

First Name & Middle Initial & Last Name & Degree

Douglas Overbey, MD

Phone

573-225-7728

douglas.overbey@ucdenver.edu

First Name & Middle Initial & Last Name & Degree

Thomas N Robinson, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No sharing

Learn more about this trial

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

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