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Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Not Applicable
Completed
Conditions
Pain
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active placeboDiphenhydramineDiphenhydramine 12.5 mg orally 2 hours preoperatively.
Gabapentin preoperativelyGabapentinPreoperative gabapentin 600 mg orally within 2 hours prior to surgery.
Primary Outcome Measures
NameTimeMethod
Average Pain Score at Rest48 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 SurgeryFirst 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 SurgerySecond morning after surgery

Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively3 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 Postoperatively24 hours
Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively48 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

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