Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
- Registration Number
- NCT00588159
- Lead Sponsor
- Michelle Kinney
- Brief Summary
One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.
- Detailed Description
The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active placebo Diphenhydramine Diphenhydramine 12.5 mg orally 2 hours preoperatively. Gabapentin preoperatively Gabapentin Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.
- Primary Outcome Measures
Name Time Method Average Pain Score at Rest 48 hours Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.
Average Pain Score With Coughing the First Morning Following Surgery First morning following surgery Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.
Average Pain Score With Coughing on Second Morning After Surgery Second morning after surgery Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
- Secondary Outcome Measures
Name Time Method Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively 3 months postoperatively Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.
Opioid Consumption in First 24 Hours Postoperatively 24 hours Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively 48 hours postoperatively Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States