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

The effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000839-16-DK

Enrollment

160

Registered

2014-03-10

Start date

2014-04-14

Completion date

Unknown

Last updated

2015-12-07

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

Conditions

Postoperative pain MedDRA version: 16.1 Level: LLT Classification code 10049124 Term: Sedation during medical procedure System Organ Class: 100000004865

Interventions

Trade Name: s-ketamin Product Name: s-ketamin Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Total morphine consumption, other than the patients usual opioid use, 0-24 hours postoperatively, administered on as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes) ;Primary end point(s): Total morphine consumption, other than the patients usual opioid use, 0-24 hours postoperatively, administered on as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes) ;Timepoint(s) of evaluation of this end point: 0 - 24 hours postoperatively;Secondary Objective: Pain score during active mobilisation, measured on a visual analogue scale (VAS), defined ad a standarised movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. Pain score during rest (VAS), at 2, 6, 12, 18 and 24 hours postoperatively. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. Degree of nausea 0-24 hours at time 2, 6, 12, 18 og 24 hours postoperatively. Number of episodes vomiting 0-24 hours, registered in periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively. Use of ondansetron during the period 0-24 hours postoperatively . Degree of sedation 0-24 hours, at time 2, 6, 12, 18 og 24 hours postoperatively. Hallucinations and nightmares 0-24 hours postoperatively. Chronic pain and daily use of opioids assessed by questionnaire 6- and 12 months postoperatively.	—

Measure

Time frame

Main Objective: Total morphine consumption, other than the patients usual opioid use, 0-24 hours postoperatively, administered on as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes) ;Primary end point(s): Total morphine consumption, other than the patients usual opioid use, 0-24 hours postoperatively, administered on as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes) ;Timepoint(s) of evaluation of this end point: 0 - 24 hours postoperatively;Secondary Objective: Pain score during active mobilisation, measured on a visual analogue scale (VAS), defined ad a standarised movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. Pain score during rest (VAS), at 2, 6, 12, 18 and 24 hours postoperatively. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. Degree of nausea 0-24 hours at time 2, 6, 12, 18 og 24 hours postoperatively. Number of episodes vomiting 0-24 hours, registered in periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively. Use of ondansetron during the period 0-24 hours postoperatively . Degree of sedation 0-24 hours, at time 2, 6, 12, 18 og 24 hours postoperatively. Hallucinations and nightmares 0-24 hours postoperatively. Chronic pain and daily use of opioids assessed by questionnaire 6- and 12 months postoperatively.

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Secondary

Measure	Time frame
Secondary end point(s): Pain score during active mobilisation, measured on a visual analogue scale (VAS), defined ad a standarised movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. • Pain score during rest (VAS), at 2, 6, 12, 18 and 24 hours postoperatively. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. • Degree of nausea 0-24 hours at time 2, 6, 12, 18 og 24 hours postoperatively. • Number of episodes vomiting 0-24 hours, registered in periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively. • Use of ondansetron during the period 0-24 hours postoperatively . • Degree of sedation 0-24 hours, at time 2, 6, 12, 18 og 24 hours postoperatively. • Hallucinations and nightmares 0-24 hours postoperatively. • Chronic pain and daily use of opioids assessed by questionnaire 6- and 12 months postoperatively. ;Timepoint(s) of evaluation of this end point: 0 - 24 hours postoperatively and 6- and 12 months postoperatively	—

Measure

Time frame

Secondary end point(s): Pain score during active mobilisation, measured on a visual analogue scale (VAS), defined ad a standarised movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. • Pain score during rest (VAS), at 2, 6, 12, 18 and 24 hours postoperatively. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements. • Degree of nausea 0-24 hours at time 2, 6, 12, 18 og 24 hours postoperatively. • Number of episodes vomiting 0-24 hours, registered in periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively. • Use of ondansetron during the period 0-24 hours postoperatively . • Degree of sedation 0-24 hours, at time 2, 6, 12, 18 og 24 hours postoperatively. • Hallucinations and nightmares 0-24 hours postoperatively. • Chronic pain and daily use of opioids assessed by questionnaire 6- and 12 months postoperatively. ;Timepoint(s) of evaluation of this end point: 0 - 24 hours postoperatively and 6- and 12 months postoperatively

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Countries

Denmark

Contacts

Public Contactdepartment of anaesthesiology

glostrup hospital

rikkevibeke@gmail.com004560926839

Outcome results

None listed

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