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Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?

NCT ID: NCT00934193

Last Updated: 2015-12-16

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

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.

Detailed Description

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This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Conditions

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Post-thoracotomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Interventions

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Gabapentin

Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Intervention Type DRUG

Placebo

Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Undergoing non-cardiac thoracic surgeries
* Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.

Exclusion Criteria

* Current gabapentin use or current treatment for neuropathic pain.
* Pregnant or considering becoming pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wichita Medical Research and Education Foundation

OTHER

Sponsor Role collaborator

Ascension Via Christi Hospitals Wichita, Inc.

OTHER

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sinisa Malinovic, MD

Role: PRINCIPAL_INVESTIGATOR

Ascension Via Christi Hospitals Wichita, Inc.

Other Identifiers

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WMREF 80104-257

Identifier Type: OTHER

Identifier Source: secondary_id

220081131

Identifier Type: -

Identifier Source: org_study_id