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OpenTrials
Completed

NCT Number: NCT02994173

Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients

To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 - 75 years of age
  • Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
  • Written informed consent from the participating patient

Exclusion criteria

  • A previous history of intolerance to the study drug or related compounds and additives
  • Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
  • Patients younger than 20 years and older than 75 years.
  • BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
  • Existing significant liver or kidney disease
  • History of ischemic heart disease or conduction disturbance
  • History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
  • Donation of blood for 4 weeks prior and during the study.

Treatment and study plan

Oxycodone

Drug

Current clinical practice, used as a control in this study

Other names: Oxanest

S-Ketamine 0.25

Drug

dosage

Other names: Ketanest-S

S-ketamine 0.5

Drug

dosage

Other names: Ketanest-S

S-Ketamine 0.75

Drug

dosage

Other names: Ketanest-S

Primary outcomes

  1. Change in opioid consumption (mg) postoperatively

    Time frame: 24 and 72 hours

    Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours

Secondary outcomes

  1. Change in numerical rating scale (NRS 0-10)

    Time frame: 24 and 72 hours

    Change from baseline NRS value postoperatively at 24 and 72 hours

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Helsinki
  • University of Turku

Registry information

Official study title

Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients

Acronym: DoseRespKeta

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2016
Registry last updated
Dec 11, 2019

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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