Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00899600|
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : April 11, 2013
Last Update Posted : October 18, 2018
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 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|
|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: Discharge from hospital, approximately 2 days after surgery ]
- Hemodynamic Changes - Heart Rate [ Time Frame: Baseline, Inoperative (approximately) 48 hours ]Hemodynamic change (Heart Rate) from baseline in the intraoperative and 48-h postoperative periods
- Hemodynamic Changes - Blood Pressure [ Time Frame: Baseline, Inoperative (approximately) 48 hours ]Hemodynamic change (Blood Pressure) from baseline in the intraoperative and 48-h postoperative periods
- Percentage of Participants With Complications/Adverse Events [ Time Frame: 48 hours and 6 weeks ]Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|