Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

NCT00588159 | Completed Results DMC

• 1 other identifier: 05-004145
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Preoperative gabapentin; Acute pain; Post-thoracotomy pain; Epidural analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Opioid Consumption in First 24 Hours Postoperatively

  24 hours

• Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively

  3 months postoperatively

• Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively

  48 hours postoperatively

Study Arms (2)

Gabapentin preoperatively

EXPERIMENTAL

Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.

Drug: Gabapentin

Active placebo

PLACEBO COMPARATOR

Diphenhydramine 12.5 mg orally 2 hours preoperatively.

Drug: Diphenhydramine

Interventions

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.

Also known as: Neurontin

Gabapentin preoperatively

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.

Also known as: Benadryl

Active placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-75 years
• Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection)

You may not qualify if:

• 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

Sponsors & Collaborators

• Michelle Kinney: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 21676165 DERIVED

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

Gabapentin; Diphenhydramine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic

Results Point of Contact

• Title: Dr. Michelle A. O. Kinney
• Organization: Mayo Clinic

kinney.michelle@mayo.edu

507-266-9877

Study Officials

• Michelle A. Kinney, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Michelle A. O. Kinney, MD

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: January 8, 2008
• Study Start: June 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 4, 2016
• Results First Posted: August 12, 2011

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)