Expired Study
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Rochester, Minnesota 55905


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.


Study summary:

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.


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


NCT ID:

NCT00588159


Primary Contact:

Principal Investigator
Michelle A. Kinney, M.D.
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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