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

December 10, 2019 updated by: Turku University Hospital

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Turku, Finland, 20521
        • Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo
Oxycodone 1 mg / ml alone
Current clinical practice, used as a control in this study
Other Names:
  • Oxanest
Active Comparator: Ketamine 0.25
Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
dosage
Other Names:
  • Ketanest-S
Active Comparator: Ketamine 0.5
Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
dosage
Other Names:
  • Ketanest-S
Active Comparator: Ketamine 0.75
Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
dosage
Other Names:
  • Ketanest-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in opioid consumption (mg) postoperatively
Time Frame: 24 and 72 hours
Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
24 and 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marko Peltoniemi, MD, PhD, Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

November 3, 2019

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 15, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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