Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

March 29, 2016 updated by: Michelle Kinney

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gabapentin preoperatively
Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.
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 Names:
  • Neurontin
Placebo Comparator: Active placebo
Diphenhydramine 12.5 mg orally 2 hours preoperatively.
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 Names:
  • Benadryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours
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.
First morning following surgery
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.
Second morning after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption in First 24 Hours Postoperatively
Time Frame: 24 hours
24 hours
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 months postoperatively
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
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michelle Kinney

Investigators

  • Principal Investigator: Michelle A. Kinney, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-004145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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