Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intra-operative Ketamine Infusions in Patients With Chronic Lower Back Discomfort Undergoing Laminectomies.|
- Morphine Consumption in the First 48 Hours After Surgery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Total morphine(mg)consumed at 48 hours.
- 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 ]
|Study Start Date:||February 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Normal saline||
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).
Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00899600
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Jeffrey A Clark, MD||DHMC|