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

NCT ID: NCT02994173

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-12-05

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Oxycodone 1 mg / ml alone

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Current clinical practice, used as a control in this study

Ketamine 0.25

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

Group Type ACTIVE_COMPARATOR

S-Ketamine 0.25

Intervention Type DRUG

dosage

Ketamine 0.5

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

Group Type ACTIVE_COMPARATOR

S-Ketamine 0.5

Intervention Type DRUG

dosage

Ketamine 0.75

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

Group Type ACTIVE_COMPARATOR

S-Ketamine 0.75

Intervention Type DRUG

dosage

Interventions

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Oxycodone

Current clinical practice, used as a control in this study

Intervention Type DRUG

S-Ketamine 0.25

dosage

Intervention Type DRUG

S-Ketamine 0.5

dosage

Intervention Type DRUG

S-Ketamine 0.75

dosage

Intervention Type DRUG

Other Intervention Names

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Oxanest Ketanest-S Ketanest-S Ketanest-S

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marko Peltoniemi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Locations

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Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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T281/2016

Identifier Type: -

Identifier Source: org_study_id