Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain
|ClinicalTrials.gov Identifier: NCT00899600|
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : April 11, 2013
Last Update Posted : May 7, 2013
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 or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Drug: Ketamine Other: Normal saline||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intra-operative Ketamine Infusions in Patients With Chronic Lower Back Discomfort Undergoing Laminectomies.|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
|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
- Morphine Consumption in the First 48 Hours After Surgery [ Time Frame: 48 hours ]Total morphine(mg)consumed at 48 hours.
- Hospital Duration [ Time Frame: 24 and 48 hours ]
- Mortality [ Time Frame: 1 year ]
- Hemodynamic Changes [ Time Frame: 24 and 48 hours ]
- Complications Related to Ketamine [ Time Frame: 24 and 48 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899600
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Jeffrey A Clark, MD||DHMC|