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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Oxycodone
S-Ketamine 0.25
S-Ketamine 0.5
S-Ketamine 0.75
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Ketamine 0.25

Ketamine 0.5

Ketamine 0.75

Arm Description

Oxycodone 1 mg / ml alone

Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)

Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)

Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in numerical rating scale (NRS 0-10)
Change from baseline NRS value postoperatively at 24 and 72 hours

Full Information

First Posted
November 3, 2016
Last Updated
December 10, 2019
Sponsor
Turku University Hospital
Collaborators
University of Turku, University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT02994173
Brief Title
Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients
Acronym
DoseRespKeta
Official Title
Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 3, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / ml alone
Arm Title
Ketamine 0.25
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
Arm Title
Ketamine 0.5
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
Arm Title
Ketamine 0.75
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxanest
Intervention Description
Current clinical practice, used as a control in this study
Intervention Type
Drug
Intervention Name(s)
S-Ketamine 0.25
Other Intervention Name(s)
Ketanest-S
Intervention Description
dosage
Intervention Type
Drug
Intervention Name(s)
S-Ketamine 0.5
Other Intervention Name(s)
Ketanest-S
Intervention Description
dosage
Intervention Type
Drug
Intervention Name(s)
S-Ketamine 0.75
Other Intervention Name(s)
Ketanest-S
Intervention Description
dosage
Primary Outcome Measure Information:
Title
Change in opioid consumption (mg) postoperatively
Description
Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
Time Frame
24 and 72 hours
Secondary Outcome Measure Information:
Title
Change in numerical rating scale (NRS 0-10)
Description
Change from baseline NRS value postoperatively at 24 and 72 hours
Time Frame
24 and 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Peltoniemi, MD, PhD
Organizational Affiliation
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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