Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588159

Purpose

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.

Condition	Intervention
Thoracotomy	Drug: Gabapentin Drug: Diphenhydramine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study

Resource links provided by NLM:

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Gabapentin Diphenhydramine citrate Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Pain scores every 4 hours for 48 hours postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Gabapentin preoperatively: Experimental Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Drug: Gabapentin 600 mg p.o. within 2 hours preoperatively
Active placebo: Placebo Comparator Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.	Drug: Diphenhydramine 12.5 mg p.o. within 2 hours preoperatively

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.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588159

Locations

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

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Michelle A. Kinney, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Michelle Kinney, M.D. )
Study ID Numbers:	05-004145
Study First Received:	December 18, 2007
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00588159 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Preoperative gabapentin
Acute pain
Post-thoracotomy pain
Epidural analgesia

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gabapentin
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Antiparkinson Agents
Antiemetics
Anesthetics
Excitatory Amino Acid Agents
Membrane Transport Modulators
Promethazine
Sensory System Agents
Therapeutic Uses

Hypnotics and Sedatives
Antipruritics
Analgesics
Dermatologic Agents
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Gastrointestinal Agents
Histamine Agents
Central Nervous System Depressants
Cardiovascular Agents
Anti-Allergic Agents
Antimanic Agents
Pharmacologic Actions
Anesthetics, Local
Histamine Antagonists

ClinicalTrials.gov processed this record on February 08, 2010