CompletedPhase 4ketamine

The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients

NCT ID

NCT02085577

Target Enrollment

147 participants

Start Date

2014-05

Est. Completion

2016-11-01

About This Study

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.

Conditions Studied

Postoperative PainChronic PainAnalgesics

Interventions

•(S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml
•Isotonic sodium chloride 0.9 percent
•Paracetamol 1 g
•Morphine Sulphate 1 mg/ml
•Morphine Sulphate 1 mg/ml
•Ondansetron 2 mg/ml
•Usual daily opioids
•Morphine Sulphate 1 mg/ml
•Sufentanil 5 microgram/ml

Eligibility

Age:18 Years - 85 Years

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Department of Anaesthesiology, Glostrup Hospital