The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
CompletedPhase 4NCT02085577
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Patients with a daily use of opioids may develop higher postoperative pain levels, often need high doses of morphine and therefore their pain may be difficult to treat. A low dose of an old anesthetic drug, ketamine, administered during surgery can possibly reduce pain and morphine consumption in these patients. Our purpose is to investigate the effect of low dose ketamine on morphine consumption and pain after spine surgery in patients with a daily use of opioids. Our hypothesis is that low dose ketamine can reduce morphine consumption, pain and side-effects after spine surgery.
Study details
- Official title
- The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
- Conditions
- Postoperative Pain
- Chronic Pain
- Analgesics
- Interventions
- Drug: (S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml
- Drug: Isotonic sodium chloride 0.9 percent
- Drug: Paracetamol 1 g
- Drug: Morphine Sulphate 1 mg/ml
- Drug: Morphine Sulphate 1 mg/ml
- Drug: Ondansetron 2 mg/ml
- Drug: Usual daily opioids
- Drug: Morphine Sulphate 1 mg/ml
- Drug: Sufentanil 5 microgram/ml
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
- Collaborators
- Glostrup University Hospital, Copenhagen
- Start date
- 2014-05
- Primary completion
- 2015-10
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients undergoing lumbar spinal fusion surgery in general anesthesia. * Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidone, oxycodone, 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 understanding the content and limitations of the study Exclusion Criteria: * Participation in another concomitant drug trial. * Patients who do not understand or speak Danish. * Allergy to the drugs used in the trial. * Abuse of drugs - as assessed by the investigator. * Daily methadone use. * Increased intraocular pressure - assessed from the patients chart. * Uncontrolled hypertension - assessed from the patients chart. * Previous and current psychotic episodes - assessed from the patients chart
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02085577