The effect og ketamine og morphine consumption and pain after spine surgery in patients with a daily morphine use

• Conditions: Postoperative pain; MedDRA version: 16.1Level: LLTClassification code 10049124Term: Sedation during medical procedureSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2014-000839-16-DK
• Lead Sponsor: HovedOrtoCentret, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-10
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Patients undergoing lumbar spinal fusion surgery i generel anaesthesia.
Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidon, oxycodon, fentanyl, tramadol and/or buprenorphine).
Back pain for a minimum of 3 months preoperatively.
Age > 18 years and < 85 years.
ASA 1-3.
BMI > 18 and < 40.
Fertile women need to have a negative urine HCG pregnancy test.
Patients who have given their written informed consent to participate in the study after having fully understood the content and limitations of 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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

Participation in another drug trial.
Patients who do not understand or speak Danish.
Allergy to the drugs used in the trial.
Abuse of drugs - assessed by the investigator.
Daily methadone use.
Increased intraocular pressure - assessed via the patients chart.
Uncontrolled hypertension - assessed via the patients chart.
Previous and current psychotic episodes - assessed via the patients chart

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified