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

NCT00899600 | Completed Results DMC

• 1 other identifier: 100674
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

chronic pain; back surgery; opioid dependent; NMDA receptor antagonism; Ketamine; Central sensitization

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption in the First 48 Hours After Surgery

  Total morphine(mg)consumed at 48 hours.

  48 hours

Secondary Outcomes (4)

• Hospital Duration

  Discharge from hospital, approximately 2 days after surgery

• Hemodynamic Changes - Heart Rate

  Baseline, Inoperative (approximately) 48 hours

• Hemodynamic Changes - Blood Pressure

  Baseline, Inoperative (approximately) 48 hours

• Percentage of Participants With Complications/Adverse Events

  48 hours and 6 weeks

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

Other: Normal saline

Ketamine

EXPERIMENTAL

Drug: Ketamine

Interventions

Ketamine DRUG

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

Ketamine

Normal saline OTHER

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).

Normal saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laminectomy procedures.
• History of chronic back pain.
• Daily opioid use.
• Capable of providing informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Randy Loftus
• Organization: Dartmouth-Hitchcock Medical Center

randy.w.loftus@hitchcock.org

6036504642

Study Officials

• Jeffrey A Clark, MD

  DHMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 18, 2018
• Results First Posted: April 11, 2013

Record last verified: 2018-09

Locations

US (1)