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Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Kinney, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588159
First received: December 18, 2007
Last updated: August 24, 2011
Last verified: August 2011

December 18, 2007
August 24, 2011
June 2007
January 2010   (final data collection date for primary outcome measure)
  • Average Pain Score at Rest [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.
  • Average Pain Score With Coughing the First Morning Following Surgery [ Time Frame: First morning following surgery ] [ Designated as safety issue: No ]
    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.
  • Average Pain Score With Coughing on Second Morning After Surgery [ Time Frame: Second morning after surgery ] [ Designated as safety issue: No ]
    Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
Pain Scores Every 4 Hours for 48 Hours Postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588159 on ClinicalTrials.gov Archive Site
  • Opioid Consumption in First 24 Hours Postoperatively [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    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.
  • Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively
  • Numeric pain ratings with coughing for 48 hours postoperatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Opioid consumption for 48 hours postoperatively [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Numeric pain ratings at 3 months postoperatively [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Opioid consumption at 3 months postoperatively [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • 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.
    Other Name: Neurontin
  • 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.
    Other Name: Benadryl
  • Experimental: Gabapentin preoperatively
    Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Active placebo
    Diphenhydramine 12.5 mg orally 2 hours preoperatively.
    Intervention: Drug: Diphenhydramine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588159
05-004145
Yes
Michelle Kinney, Mayo Clinic
Michelle Kinney
Not Provided
Principal Investigator: Michelle A. Kinney, M.D. Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP