Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Michelle Kinney

Status: Completed

Conditions: Pain

Treatments: Drug: Diphenhydramine; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT00588159

05-004145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 2 patient groups, including a placebo group

Gabapentin preoperatively

Experimental group

Description:

Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.

Treatment:

Drug: Gabapentin

Active placebo

Placebo Comparator group

Description:

Diphenhydramine 12.5 mg orally 2 hours preoperatively.

Treatment:

Drug: Diphenhydramine