Clinical TrialChronic PainKetaminePlaceboTerminated

Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery

This double-blind, placebo-controlled trial (n=1, terminated) aimed to determine whether perioperative ketamine (bolus 1 mg/kg + infusion 0.20 mg/kg/hr) increases postoperative pain tolerance and reduces opioid consumption in opioid-dependent patients undergoing spinal laminectomy/fusion.

Target Enrollment
1 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, double-blind, placebo-controlled Phase II trial in opioid-dependent patients undergoing lumbar/thoracic/cervical spine surgery assessing perioperative ketamine (1 mg/kg IV bolus then 0.20 mg/kg/hr infusion, max 20 mg/hr).

Primary outcome: hydromorphone PCA usage in the first 72 hours postoperatively. Secondary outcomes include VAS pain scores at multiple timepoints, McGill Pain Questionnaire, Pain Catastrophizing Scale, PROMIS emotional distress measures, Neuro-QOL satisfaction with social roles, and opioid consumption converted to morphine equivalents.

Participants were recruited from the University of Pittsburgh Medical Center neurosurgery clinics and operating rooms; consent and enrollment performed by surgical team or PI with coordinator support.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Intraoperative bolus followed by postoperative continuous ketamine infusion for opioid-dependent patients undergoing spine surgery.

Interventions

  • Ketamine1 mg/kg
    via IV• bolus then infusion

    Bolus 1 mg/kg IV 15 minutes after induction; then infusion 0.20 mg/kg/hr (max 20 mg/hr) continued until 48 hours after surgery.

Placebo

inactive

Matching saline bolus and infusion.

Interventions

  • Placebo
    via IV• bolus then infusion

    Saline bolus 15 minutes after induction and saline infusion matched to ketamine schedule (placebo comparator).

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Patients undergoing lumbar, thoracic or cervical spine surgery of at least one level and no more than six levels.
  • Chronic back pain (>3 months).
  • ASA 1-3.
  • Opiate-dependent with daily opioid use for at least 2 months and regimented daily narcotic dose twice a day (BID) or greater or use of a regimented opioid pump.

Exclusion Criteria

  • Intolerance or known allergy to ketamine.
  • History of increased intraocular pressure (>22 mmHg).
  • Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg).
  • Increased intracranial pressure.
  • History of psychosis.
  • Pregnancy.
  • Significant liver disease (signs/symptoms or elevated LFTs: AST >120 IU/ml, AP >130 IU/ml, ALT >40 IU/ml).
  • Exposure to CYP3A and/or CYP2B6 inhibitors (see FDA drug interactions guidance).

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment1 participants
  • Timeline
    Start: 2019-12-17
    End: 2022-11-19
  • Compounds
    KetaminePlacebo
  • Topic
    Chronic Pain

Locations

Jacques E Chelly, MD — Pittsburgh, Pennsylvania, United States

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