ssTAP vs TAP Catheters in TAH

NCT ID: NCT02525900

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-12

Study Completion Date

2018-06-05

Brief Summary

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Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wound Infiltration

0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration

Group Type PLACEBO_COMPARATOR

Wound Infiltration

Intervention Type PROCEDURE

Wound Infiltration with 0.25% Bupivacine

TAP Blocks

20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures

Group Type EXPERIMENTAL

TAP Blocks

Intervention Type PROCEDURE

bilateral TAP block with 0.25% Bupivacaine

TAP Catheters

20mL of 0.25% bupivacaine will be injection on each side of the abdomen and catheters placed for repeat bolus every 12 hours with 20mL of 0.25% Bupivacine until 48 hours post procedure or hospital discharge.

Group Type EXPERIMENTAL

TAP Catheters

Intervention Type PROCEDURE

bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine

Interventions

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Wound Infiltration

Wound Infiltration with 0.25% Bupivacine

Intervention Type PROCEDURE

TAP Blocks

bilateral TAP block with 0.25% Bupivacaine

Intervention Type PROCEDURE

TAP Catheters

bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled to undergo total abdominal hysterectomy
* Age ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria

* Known coagulopathy
* Known allergy to Bupivacaine or morphine
* Contraindication to Tylenol usage
* Medical conditions contraindicated to bupivacaine use
* Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Tingle, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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204411

Identifier Type: -

Identifier Source: org_study_id

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