Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
|ClinicalTrials.gov Identifier: NCT00588159|
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : August 12, 2011
Last Update Posted : May 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Gabapentin Drug: Diphenhydramine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||March 2010|
Experimental: Gabapentin preoperatively
Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.
gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
Other Name: Neurontin
Placebo Comparator: Active placebo
Diphenhydramine 12.5 mg orally 2 hours preoperatively.
Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
Other Name: Benadryl
- Average Pain Score at Rest [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Second morning after surgery ]Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
- Opioid Consumption in First 24 Hours Postoperatively [ Time Frame: 24 hours ]
- Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively [ Time Frame: 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 Second 24 Hour Hour Period (Hours 24-48) Postoperatively [ Time Frame: 48 hours postoperatively ]Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588159
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Michelle A. Kinney, M.D.||Mayo Clinic|