Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Condition(s) targeted: Pain

Intervention: Gabapentin (Drug); Diphenhydramine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Michelle Kinney

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Average Pain Score at Rest

Average Pain Score With Coughing the First Morning Following Surgery

Average Pain Score With Coughing on Second Morning After Surgery

Secondary outcome:

Opioid Consumption in First 24 Hours Postoperatively

Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively

Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) 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

Mayo Clinic Clinical Trials

Starting date: June 2007
Last updated: August 24, 2011