Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|