Post-thoracotomy Pain
Conditions
Brief summary
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
Detailed description
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.
Interventions
DRUGGabapentin
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.
DRUGPlacebo
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.
Sponsors
Wichita Medical Research and Education Foundation
Ascension Via Christi Hospitals Wichita, Inc.
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain. | 6 Months |
Outcome results
None listed