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

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Oxycodone; Drug: S-Ketamine 0.25; Drug: S-Ketamine 0.5; Drug: S-Ketamine 0.75

Study type: Interventional

Funder types: Other

Identifiers

NCT02994173

T281/2016

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 4 patient groups

Placebo

Active Comparator group

Description:

Oxycodone 1 mg / ml alone

Treatment:

Drug: Oxycodone

Ketamine 0.25

Active Comparator group

Description:

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

Treatment:

Drug: S-Ketamine 0.25

Ketamine 0.5

Active Comparator group

Description:

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

Treatment:

Drug: S-Ketamine 0.5

Ketamine 0.75

Active Comparator group

Description:

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

Treatment:

Drug: S-Ketamine 0.75