Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

NCT ID: NCT00588159

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-03-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin preoperatively

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

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

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.

Active placebo

Diphenhydramine 12.5 mg orally 2 hours preoperatively.

Group Type: PLACEBO_COMPARATOR

Diphenhydramine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Neurontin; Benadryl

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michelle Kinney

OTHER

Sponsor Role: lead

Responsible Party

Michelle Kinney

Michelle A. O. Kinney, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michelle A. Kinney, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Kinney MA, Mantilla CB, Carns PE, Passe MA, Brown MJ, Hooten WM, Curry TB, Long TR, Wass CT, Wilson PR, Weingarten TN, Huntoon MA, Rho RH, Mauck WD, Pulido JN, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Shen KR, Wigle DA, Hoehn SL, Alexander SL, Hanson AC, Schroeder DR. Preoperative gabapentin for acute post-thoracotomy analgesia: a randomized, double-blinded, active placebo-controlled study. Pain Pract. 2012 Mar;12(3):175-83. doi: 10.1111/j.1533-2500.2011.00480.x. Epub 2011 Jun 16.

Reference Type: DERIVED

PMID: 21676165 (View on PubMed)

Other Identifiers

05-004145

Identifier Type: -

Identifier Source: org_study_id