The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

NCT ID: NCT02263963

Last Updated: 2023-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

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

SINGLE

Participants

Study Groups

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TAP Block Experal

Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.

TAP Block

Intervention Type PROCEDURE

no intervention will be done to this arm.

No TAP Block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exparel

In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.

Intervention Type DRUG

TAP Block

no intervention will be done to this arm.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients over the age of 18 years w
2. Elective laparoscopic colorectal resection.

Exclusion Criteria

1. Patients under 18 years.
2. Patients unable to provide informed consent
3. Patients undergoing emergency surgery.
4. Pregnant women
5. Severe liver or kidney disease (GFR 15-29 ml/min)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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DDI.FY13.07

Identifier Type: OTHER

Identifier Source: secondary_id

2013-066

Identifier Type: -

Identifier Source: org_study_id

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