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NCT Number: NCT02085577

The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients

Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Our purpose is to investigate the effect of low dose ketamine on morphine consumption and pain after spine surgery in patients with a daily use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and side-effects after spine surgery.

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Key information

Conditions

Postoperative Pain Analgesics Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

About this study

Opioid-dependent patients can develop hyperalgesia and often have a high opioid consumption postoperatively due to opioid tolerance. Intraoperative ketamine in subanesthetic doses can possibly reduce hyperalgesia and reduce opioid-tolerance in these patients. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nerve system. It can be used for general anesthesia but the drug also has other properties including lowering of central excitability and reducing postoperative opioid tolerance by modeling the opioid receptors. Further more it can possibly reduce chronic pain by blocking wind-up effect when blocking the NMDA receptors.

Our purpose is to investigate the effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients. Our hypothesis is that ketamine can reduce opioid consumption and reduce postoperative pain and side effects compared to placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing lumbar spinal fusion surgery in general anesthesia.
  • Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidone, oxycodone, fentanyl, tramadol and/or buprenorphine).
  • Back pain for a minimum of 3 months preoperatively.
  • Age > 18 years and < 85 years.
  • ASA 1-3.
  • BMI > 18 and < 40.
  • Fertile women need to have a negative urine HCG pregnancy test.
  • Patients who have given their written informed consent to participate in the study after understanding the content and limitations of the study

Exclusion criteria

  • Participation in another concomitant drug trial.
  • Patients who do not understand or speak Danish.
  • Allergy to the drugs used in the trial.
  • Abuse of drugs - as assessed by the investigator.
  • Daily methadone use.
  • Increased intraocular pressure - assessed from the patients chart.
  • Uncontrolled hypertension - assessed from the patients chart.
  • Previous and current psychotic episodes - assessed from the patients chart

Treatment and study plan

(S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml

Drug

Ketamine (25 mg/ml) bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/hour that is terminated when the last suture to the skin has been performed.

Other names: Ketamine

Isotonic sodium chloride 0.9 percent

Drug

Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/hour that is terminated when the last suture to the skin has been performed.

Other names: Isotonic saline

Paracetamol 1 g

Drug

Paracetamol 1 g orally 1 hour preoperatively and every 6 hours after extubation time during the first 24 hours.

Other names: Paracetamol

Morphine Sulphate 1 mg/ml

Drug

Morphine Sulphate 1 mg/ml administered as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 5 minutes) 0-24 hours postoperatively

Other names: Morphine

Ondansetron 2 mg/ml

Drug

Ondansetron 2 mg/ml 4 mg iv in case of moderate to severe nausea, supplemented by Ondansetron 1 mg iv if needed

Other names: Zofran

Usual daily opioids

Drug

The patients usual daily opioid consumption are administered during the study period

Other names: Morphine

Sufentanil 5 microgram/ml

Drug

Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.

Other names: Sufentanil

Primary outcomes

  1. Morphine consumption

    Time frame: 0-24 hours postoperatively

    Total intravenous morphine consumption, other than the patients usual opioid use, 0- 24 hours postoperatively, administered as patient-controlled analgesia ((PCA), bolus 2.5 mg, lockout 5 minutes)

Secondary outcomes

  1. Pain during mobilization

    Time frame: 2, 6, 12, 18 and 24 hours postoperatively

    Pain score during active mobilization, measured on a visual analogue scale (VAS) (0-100 mm), defined as a standardized movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. The endpoint, VAS-mobilization, will be calculated as area under the curve (AUC) (2-24h) from these measurements.

  2. Pain at rest

    Time frame: 2, 6, 12, 18 & 24 hours postoperatively

    Pain score at rest, measured on a visual analogue scale (VAS) (0-100 mm), at 2, 6, 12, 18 and 24 hours postoperatively. The endpoint, VAS-rest, will be calculated as area under the curve (AUC) (2-24h) from these measurements.

  3. Nausea

    Time frame: 2, 6, 12, 18 & 24 hours postoperatively

    Level of nausea (none, mild, moderate, severe) (0-24h), measured at 2, 6, 12, 18 and 24 hours postoperatively.

  4. Vomiting

    Time frame: 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively

    Number of vomiting episodes (0-24 hours), registered in the periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively.

  5. Ondansetron

    Time frame: 0-24 hours postoperatively

    Consumption of ondansetron (mg) during 0-24 hours postoperatively.

  6. Sedation

    Time frame: 2, 6, 12, 18 & 24 hours postoperatively

    Level of sedation (none, mild, moderate, severe) (0-24 h) registered at time 2, 6, 12, 18 and 24 hours postoperatively.

  7. Hallucinations and nightmares

    Time frame: 0-24 hours postoperatively

    Episodes of hallucinations and nightmares (yes/no) in the period 0-24 hours postoperatively.

  8. Chronic pain

    Time frame: 6 months postoperatively

    Level of chronic pain and daily use of opioids assessed by the validated questionnaires EQ50, OWESTRY and DN4 at 6 months postoperatively.

  9. Chronic pain

    Time frame: 12 months postoperatively

    Level of chronic pain and daily use of opioids assessed by the validated questionnaires EQ50, OWESTRY and DN4 at 12 months postoperatively.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Glostrup University Hospital, Copenhagen

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 13, 2014
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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