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Ketamine to reduce postoperative pain in back surgery

Administration of S-Ketamine during spinal surgery to reduce postoperative pain

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000747-26-FI
Enrollment
192
Registered
2012-04-02
Start date
2012-04-27
Completion date
Unknown
Last updated
2019-02-28

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

Conditions

adult patients undergoing spinal surgery MedDRA version: 14.1 Level: LLT Classification code 10041595 Term: Spinal stenosis lumbar System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Ketanest-S Product Name: Ketanest-S Pharmaceutical Form: Injection CAS Number: 33643-46-8 Other descriptive name: ESKETAMINE

Sponsors

Helsinki Universiy Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective posterior lumbar fusion surgery volunteering for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 192 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: BMI>35, unstable ischaemic cardiac disease, increased intracranial pressure, increased intraocular pressure, gravidity, lactation, hypersensitivity or allergy to ketamine, oxycodone, propofol or remifentanil, severe psychiatric disease, unwillingness or unability to use PCA-device, unability to use NRS-pain scale

Design outcomes

Primary

MeasureTime frame
Main Objective: to reduce the need of opioids after surgery;Secondary Objective: to reduce postoperative confusion, pain, depression;Primary end point(s): consumption of oxycodone with PCA-device 48 hours after the surgery;Timepoint(s) of evaluation of this end point: 48 hours after the surgery

Secondary

MeasureTime frame
Secondary end point(s): confusion in the postoperative care unit, pain, depression ; Timepoint(s) of evaluation of this end point: confusion in the postoperative care unit approximately 4 hours pain 48 hours after surgery, 3 months after surgery and 24 after surgery depression before surgery and 3 months after surgery

Countries

Finland

Contacts

Public ContactKipuklinikka

Helsinki University Hospital

vesa.kontinen@hus.fi+35894711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026