Chronic Pain Clinical Trial
Official title:
The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients
Verified date | April 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | November 1, 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Anaesthesiology, Glostrup Hospital | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Glostrup University Hospital, Copenhagen |
Denmark,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine consumption | Total intravenous morphine consumption, other than the patients usual opioid use, 0- 24 hours postoperatively, administered as patient-controlled analgesia ((PCA), bolus 2.5 mg, lockout 5 minutes) | 0-24 hours postoperatively | |
Secondary | Pain during mobilization | Pain score during active mobilization, measured on a visual analogue scale (VAS) (0-100 mm), defined as a standardized 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. The endpoint, VAS-mobilization, will be calculated as area under the curve (AUC) (2-24h) from these measurements. | 2, 6, 12, 18 and 24 hours postoperatively | |
Secondary | Pain at rest | Pain score at rest, measured on a visual analogue scale (VAS) (0-100 mm), at 2, 6, 12, 18 and 24 hours postoperatively. The endpoint, VAS-rest, will be calculated as area under the curve (AUC) (2-24h) from these measurements. | 2, 6, 12, 18 & 24 hours postoperatively | |
Secondary | Nausea | Level of nausea (none, mild, moderate, severe) (0-24h), measured at 2, 6, 12, 18 and 24 hours postoperatively. | 2, 6, 12, 18 & 24 hours postoperatively | |
Secondary | Vomiting | Number of vomiting episodes (0-24 hours), registered in the periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively. | 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively | |
Secondary | Ondansetron | Consumption of ondansetron (mg) during 0-24 hours postoperatively. | 0-24 hours postoperatively | |
Secondary | Sedation | Level of sedation (none, mild, moderate, severe) (0-24 h) registered at time 2, 6, 12, 18 and 24 hours postoperatively. | 2, 6, 12, 18 & 24 hours postoperatively | |
Secondary | Hallucinations and nightmares | Episodes of hallucinations and nightmares (yes/no) in the period 0-24 hours postoperatively. | 0-24 hours postoperatively | |
Secondary | Chronic pain | Level of chronic pain and daily use of opioids assessed by the validated questionnaires EQ50, OWESTRY and DN4 at 6 months postoperatively. | 6 months postoperatively | |
Secondary | Chronic pain | Level of chronic pain and daily use of opioids assessed by the validated questionnaires EQ50, OWESTRY and DN4 at 12 months postoperatively. | 12 months postoperatively |
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