Intra-Operative Ketamine Infusions in Opioid-Dependent Patients With Chronic Lower Back Pain - Full Text View

Sponsored by:	Dartmouth-Hitchcock Medical Center
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00899600

Purpose

Noxious stimuli occurring intraoperatively and postoperatively generate central sensitization, decreasing pain thresholds and ultimately increasing analgesic requirements. The pathophysiology of central sensitization is thought to involve excitatory amino acid receptors such as N-methyl-d-aspartate (NMDA) (1, 2). Ketamine is a N-methyl-d-aspartate (NMDA) receptor antagonist that has been shown to be useful in the reduction of acute postoperative pain and analgesic consumption in a variety of surgical interventions (3).

Spine surgery provides a unique opportunity to evaluate the preemptive and preventative impact of ketamine on the primary end points of postoperative 24 and 48 hour opioid consumption in patients with chronic pain. The goal of this IRB approved double blinded, prospective, randomized placebo controlled trial is to quantify the preemptive and preventative analgesic effects of ketamine infusions in this patient population. Such insight may lead to better pain control, improved satisfaction, and ultimately a reduction in side-effects related to postoperative opioid use.

Condition	Intervention
Chronic Low Back Pain	Drug: Ketamine Other: Normal saline

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Intra-Operative Ketamine Infusions in Patients With Chronic Lower Back Discomfort Undergoing Laminectomies.

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Surgery

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

Morphine consumption and pain scores in the first 24 and 48 hours and at 6 weeks [ Time Frame: 24 and 48 hours, 6 weeks postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital duration [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Hemodynamic changes [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
Complications related to ketamine [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	February 2007
Estimated Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Normal saline: Placebo Comparator	Other: Normal saline Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
Ketamine: Experimental	Drug: Ketamine Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Laminectomy procedures.
History of chronic back pain.
Daily opioid use.
Capable of providing informed consent.

Exclusion Criteria:

Intolerance/allergy to ketamine.
Intolerance/true allergy to morphine.
Elevated intra-ocular pressure.
Uncontrolled hypertension.
Elevated intra-cranial pressure.
Any history of a psychosis.
Pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899600

Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

Principal Investigator:

Jeffrey A Clark, MD

DHMC

More Information

No publications provided

Responsible Party:	Dartmouth-Hitchcock Medical Center Department of Anesthesiology ( Jeffrey A. Clark )
Study ID Numbers:	100674
Study First Received:	May 8, 2009
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00899600 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

chronic pain
back surgery
opioid dependent

NMDA receptor antagonism
Ketamine
Central sensitization

Study placed in the following topic categories:

Anesthetics, Intravenous
Excitatory Amino Acids
Neurotransmitter Agents
Low Back Pain
Anesthetics
Central Nervous System Depressants
Pain
Back Pain

Anesthetics, Dissociative
Signs and Symptoms
Anesthetics, General
Ketamine
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Low Back Pain
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Pain
Back Pain
Pharmacologic Actions

Anesthetics, Dissociative
Signs and Symptoms
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Ketamine
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on September 11, 2009