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

NCT00934193 | Withdrawn Phase 3

• 2 other identifiers: 220081131WMREF 80104-257
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post-thoracotomy Pain

Outcome Measures

Primary Outcomes (1)

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

  6 Months

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gabapentin 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.

Gabapentin

Placebo 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current gabapentin use or current treatment for neuropathic pain.
• Pregnant or considering becoming pregnant.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Wichita Medical Research and Education Foundation: collaborator
• Ascension Via Christi Hospitals Wichita, Inc.: collaborator

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sinisa Malinovic, MD

  Ascension Via Christi Hospitals Wichita, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 16, 2015

Record last verified: 2015-12