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

Pain, Postoperative Clinical Trial

— DoseRespKeta  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994173
• Other study ID #: T281/2016
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: December 5, 2019

Study information

• Verified date: December 2019
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 5, 2019
• Est. primary completion date: November 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Oxycodone
Current clinical practice, used as a control in this study
• S-Ketamine 0.25
dosage
• S-Ketamine 0.5
dosage
• S-Ketamine 0.75
dosage

Locations

Country	Name	City	State
Finland	Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in opioid consumption (mg) postoperatively	Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours	24 and 72 hours
Secondary	Change in numerical rating scale (NRS 0-10)	Change from baseline NRS value postoperatively at 24 and 72 hours	24 and 72 hours