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Completed

NCT Number: NCT00588159

Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

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.

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Key information

Conditions

Pain Acute Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

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.

Other names: Neurontin

diphenhydramine

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.

Other names: Benadryl

Primary outcomes

  1. Average Pain Score at Rest

    Time frame: 48 hours

    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.

  2. Average Pain Score With Coughing the First Morning Following Surgery

    Time frame: 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.

  3. Average Pain Score With Coughing on Second Morning After Surgery

    Time frame: Second morning after surgery

    Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.

Secondary outcomes

  1. Opioid Consumption in First 24 Hours Postoperatively

    Time frame: 24 hours

  2. Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively

    Time frame: 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. Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively

    Time frame: 48 hours postoperatively

    Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively

Sponsors and collaborators

Lead sponsor

Michelle Kinney

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2008
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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