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

Sponsor:	Michelle Kinney
Information provided by (Responsible Party):	Michelle Kinney, 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
Pain	Drug: Gabapentin Drug: Diphenhydramine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Gabapentin enacarbil Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Enrollment:	146
Study Start Date:	June 2007
Study Completion Date:	March 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Benadryl

Arms

Assigned Interventions

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 Name: 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 Name: Benadryl

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

Michelle Kinney

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:	Michelle Kinney, Michelle A. O. Kinney, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00588159 History of Changes
Other Study ID Numbers:	05-004145
Study First Received:	December 18, 2007
Results First Received:	December 28, 2010
Last Updated:	August 24, 2011
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:

Diphenhydramine
Promethazine
Gabapentin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Analgesics
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on February 09, 2012