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Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain

NCT00899600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-10-18

Study results available
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Summary

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.

Conditions

  • Chronic Low Back Pain

Interventions

DRUG

Ketamine

Peripheral provision of 0.5mg/kg of ketamine on induction followed by a 10mcg/kg/min infusion until surgical wound closure

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).

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey A Clark, MD · DHMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00899600 on ClinicalTrials.gov