Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia | RxWiki

Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Pain
Intervention	Drug: Gabapentin Drug: Diphenhydramine
Phase	N/A
Sponsor	Michelle Kinney
Responsible Party	Mayo Clinic
ClinicalTrials.gov Identifier	NCT00588159
First Received	December 18, 2007
Last Updated	August 24, 2011
Last verified	August 2011

Tracking Information[ + expand ][ + ]

First Received Date	December 18, 2007
Last Updated Date	August 24, 2011
Start Date	June 2007
Estimated Primary Completion Date	March 2010
Current Primary Outcome Measures	Average Pain Score at Rest [Time Frame: 48 hours] [Designated as safety issue: No]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] [Designated as safety issue: No]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] [Designated as safety issue: No]Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
Current Secondary Outcome Measures	Opioid Consumption in First 24 Hours Postoperatively [Time Frame: 24 hours] [Designated as safety issue: No] Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively [Time Frame: 3 months postoperatively] [Designated as safety issue: No]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] [Designated as safety issue: No]Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively

Descriptive Information[ + expand ][ + ]

Brief Title	Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Official Title	Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study
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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Pain
Intervention	Drug: Gabapentin 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 Names: NeurontinDrug: Diphenhydramine 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 Names: Benadryl
Study Arm (s)	Experimental: Gabapentin preoperatively Preoperative gabapentin 600 mg orally within 2 hours prior to surgery. Placebo Comparator: Active placebo Diphenhydramine 12.5 mg orally 2 hours preoperatively.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	146
Estimated Completion Date	March 2010
Estimated Primary Completion Date	January 2010
Eligibility Criteria	Inclusion criteria: - Age 45-75 years - Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection) Exclusion criteria: - Undergoing chest wall resection, gastroesophageal surgery - Enrolled in another post-thoracotomy analgesic research protocol - Pre-existing pain syndrome - Current gabapentin or pregabalin therapy - Inability to understand the study protocol - Coagulopathy - Current use of anticoagulants - Allergy to medications on protocol - Creatinine >1.3 - Moderate or severe aortic stenosis - Severe psychological disorders - Bacteremia, osteomyelitis, or infection at site of thoracic epidural placement - History of previous thoracotomy - Patient declines preoperative epidural catheter placement - Prisoners or other institutionalized individuals - Severe hepatic, renal or cardiovascular disorders - Women who can become pregnant
Gender	Both
Ages	45 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00588159
Other Study ID Numbers	05-004145
Has Data Monitoring Committee	Yes
Information Provided By	Mayo Clinic
Study Sponsor	Michelle Kinney
Collaborators	Not Provided
Investigators	Principal Investigator: Michelle A. Kinney, M.D. Mayo Clinic
Verification Date	August 2011

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