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

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ClinicalTrials.gov Identifier: NCT00899600
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : April 11, 2013
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Ketamine Other: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Ketamine

Arm Intervention/treatment
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).

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




Primary Outcome Measures :
  1. Morphine Consumption in the First 48 Hours After Surgery [ Time Frame: 48 hours ]
    Total morphine(mg)consumed at 48 hours.


Secondary Outcome Measures :
  1. Hospital Duration [ Time Frame: Discharge from hospital, approximately 2 days after surgery ]
  2. 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

  3. 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

  4. Percentage of Participants With Complications/Adverse Events [ Time Frame: 48 hours and 6 weeks ]
    Adverse events



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Jeffrey A Clark, MD DHMC
Publications:
1. Wall PD. The prevention of postoperative pain. Pain 1988; 33: 289-90. 2. Katz J. George Washington Crile, anoci-association, and preemptive analgesia. Pain 1993;53: 243-5. 3. McQual HJ. Pre-emptive analgesia. Br J Anaesth 1992;69: 1-3. 4. Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology 2002;96: 725-41. 5. Katz J. Pre-emptive analgesia: evidence, current status and future directions. Eur J Anaesthesiol Suppl 995;10:8-13. 6. Katz J, McCartney CJ. Update on pre-emptive analgesia. Curr Opin Anesthesiol 2002; 15: 435-41. 7. McCartney et al. A qualitative systematic review of the role of N-Methyl-D-Aspartate receptor antagonists in preventative analgesia. Anesth Analg 2004; 98: 1385-1400. 8. Wu CT, Yeh CC, Yu JC, et al. Pre-incisional epidural ketamine, morphine and bupivacaine combined with epidural and general anesthesia provides pre-emptive analgesia for upper abdominal surgery. Acta Anaesthesiol Scand 2000;44: 63-8.

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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00899600    
Other Study ID Numbers: 100674
First Posted: May 12, 2009    Key Record Dates
Results First Posted: April 11, 2013
Last Update Posted: October 18, 2018
Last Verified: September 2018
Keywords provided by Dartmouth-Hitchcock Medical Center:
chronic pain
back surgery
opioid dependent
NMDA receptor antagonism
Ketamine
Central sensitization
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action