Clinical trial NCT02085577: The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
Official title: The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Chronic Pain
Analgesics
Keywords: Morphine consumption
Postoperative pain
Ketamine
Side effects
Spine surgery
Chronic pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
First posted: 2014-03-13
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Opioid-dependent patients can develop hyperalgesia and often have a high opioid consumption postoperatively due to opioid tolerance. Intraoperative ketamine in subanesthetic doses can possibly reduce hyperalgesia and reduce opioid-tolerance in these patients. Ketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nerve system. It can be used for general anesthesia but the drug also has other properties including lowering of central excitability and reducing postoperative opioid tolerance by modeling the opioid receptors. Further more it can possibly reduce chronic pain by blocking wind-up effect when blocking the NMDA receptors.

Our purpose is to investigate the effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients. Our hypothesis is that ketamine can reduce opioid consumption and reduce postoperative pain and side effects compared to placebo.

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

Primary outcomes:
measure: Morphine consumption
timeFrame: 0-24 hours postoperatively
Secondary outcomes:
measure: Pain during mobilization
timeFrame: 2, 6, 12, 18 and 24 hours postoperatively
measure: Pain at rest
timeFrame: 2, 6, 12, 18 & 24 hours postoperatively
measure: Nausea
timeFrame: 2, 6, 12, 18 & 24 hours postoperatively
measure: Vomiting
timeFrame: 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively
measure: Ondansetron
timeFrame: 0-24 hours postoperatively
measure: Sedation
timeFrame: 2, 6, 12, 18 & 24 hours postoperatively
measure: Hallucinations and nightmares
timeFrame: 0-24 hours postoperatively
measure: Chronic pain
timeFrame: 6 months postoperatively
measure: Chronic pain
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Anaesthesiology, Glostrup Hospital
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Rikke V Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.