Clinical trial NCT00588159: Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Official title: Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Preoperative gabapentin
Acute pain
Post-thoracotomy pain
Epidural analgesia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 146
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average Pain Score at Rest
timeFrame: 48 hours
measure: Average Pain Score With Coughing the First Morning Following Surgery
timeFrame: First morning following surgery
measure: Average Pain Score With Coughing on Second Morning After Surgery
timeFrame: Second morning after surgery
Secondary outcomes:
measure: Opioid Consumption in First 24 Hours Postoperatively
timeFrame: 24 hours
measure: Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively
timeFrame: 3 months postoperatively
measure: Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michelle A. Kinney, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.