Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588159
• Other study ID #: 05-004145
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: August 24, 2011
• Start date: June 2007
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Michelle Kinney

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Opioid Consumption in First 24 Hours Postoperatively		24 hours	No
Secondary	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	No
Secondary	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	No

External Links

•   Mayo Clinic Clinical Trials