NCT02994173

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

November 3, 2016

Last Update Submit

December 10, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Change in opioid consumption (mg) postoperatively

    Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours

    24 and 72 hours

Secondary Outcomes (1)

  • Change in numerical rating scale (NRS 0-10)

    24 and 72 hours

Study Arms (4)

Placebo

ACTIVE COMPARATOR

Oxycodone 1 mg / ml alone

Drug: Oxycodone

Ketamine 0.25

ACTIVE COMPARATOR

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

Drug: S-Ketamine 0.25

Ketamine 0.5

ACTIVE COMPARATOR

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

Drug: S-Ketamine 0.5

Ketamine 0.75

ACTIVE COMPARATOR

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

Drug: S-Ketamine 0.75

Interventions

OxycodoneDRUG

Current clinical practice, used as a control in this study

Also known as: Oxanest
Placebo
S-Ketamine 0.25DRUG

dosage

Also known as: Ketanest-S
Ketamine 0.25
S-Ketamine 0.5DRUG

dosage

Also known as: Ketanest-S
Ketamine 0.5
S-Ketamine 0.75DRUG

dosage

Also known as: Ketanest-S
Ketamine 0.75

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Marko Peltoniemi, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

December 15, 2016

Study Start

February 1, 2017

Primary Completion

November 3, 2019

Study Completion

December 5, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)