Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Diphenhydramine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin preoperatively<br>Preoperative gabapentin 600 mg orally within 2 hours prior to surgery. | Drug: Gabapentin<br>* 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.<br>* Other names: Neurontin;|
| Placebo Comparator: Active placebo<br>Diphenhydramine 12.5 mg orally 2 hours preoperatively. | Drug: Diphenhydramine<br>* 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.<br>* Other names: Benadryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Score at Rest | Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine. | 48 hours | 
| Average Pain Score With Coughing the First Morning Following Surgery | Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10. | First morning following surgery | 
| Average Pain Score With Coughing on Second Morning After Surgery | Numeric rating scale pain score with coughing on second morning after surgery, range 0-10. | Second morning after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption in First 24 Hours Postoperatively |  | 24 hours | 
| Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively. | 3 months postoperatively | 
| Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively | 48 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative gabapentin, Acute pain, Post-thoracotomy pain, Epidural analgesia