Dose-response of ketamine in patient controlled analgesia in orthopaedic surgery patients

Phase 1

• Conditions: Patients who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation; MedDRA version: 19.0Level: LLTClassification code 10041595Term: Spinal stenosis lumbarSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2016-002887-14-FI
• Lead Sponsor: niversity of Turku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-14
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 20 - 75 years of age
2. Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
3. Written informed consent from the participating patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This randomized, double-blinded, controlled study is aimed to study the dose-response using combining adjunct S-ketamine with oxycodone in intravenous PCA bolus dosing in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation. ;Secondary Objective: Building a pharmacokinetic-pharmacodynamic model for S-ketamine and oxycodone;Primary end point(s): All planned blood samples have been drawn;Timepoint(s) of evaluation of this end point: 72 h after the end of surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): All pain measurements have been recorded;Timepoint(s) of evaluation of this end point: 72 hours after the end of surgery