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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02994173
Acronym
DoseRespKeta
Enrollment
100
Registered
2016-12-15
Start date
2017-02-01
Completion date
2019-12-05
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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

Interventions

DRUGOxycodone

Current clinical practice, used as a control in this study

DRUGS-Ketamine 0.25

dosage

DRUGS-Ketamine 0.5

dosage

DRUGS-Ketamine 0.75

dosage

Sponsors

University of Turku
CollaboratorOTHER
University of Helsinki
CollaboratorOTHER
Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in opioid consumption (mg) postoperatively24 and 72 hoursChange from baseline opioid consumption (mg) postoperatively at 24 and 72 hours

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026