Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Condition(s) targeted: Thoracotomy

Intervention: Gabapentin (Drug); Diphenhydramine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Michelle A. Kinney, M.D., Principal Investigator, Affiliation: Mayo Clinic

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.

Official title: Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Pain scores every 4 hours for 48 hours postoperatively.

Secondary outcome:

Numeric pain ratings with coughing for 48 hours postoperatively

Opioid consumption for 48 hours postoperatively

Numeric pain ratings at 3 months postoperatively

Opioid consumption at 3 months postoperatively

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.

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.

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

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Michelle A Kinney, M.D., Phone: 507-266-9877, Email: kinney.michelle@mayo.edu
Michelle A Kinney, M.D., Principal Investigator

Mayo Clinic Clinical Trials

Starting date: June 2007
Ending date: December 2010
Last updated: July 30, 2009