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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: S-Ketamine 0.25; Drug: S-Ketamine 0.5; Drug: S-Ketamine 0.75; Drug: Oxycodone

• Registration Number: NCT02994173
• Lead Sponsor: Turku University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Study Start: 2017-02-01
• Primary Completion: 2019-11-03
• Status Verified: 2019-12
• Study Completion: 2019-12-05
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine 0.25	S-Ketamine 0.25	Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
Ketamine 0.5	S-Ketamine 0.5	Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
Ketamine 0.75	S-Ketamine 0.75	Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
Placebo	Oxycodone	Oxycodone 1 mg / ml alone

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital; 🇫🇮 Turku, Finland