SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00618423
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
After a surgical operation, patients may suffer from chronic pain. Ketamine, a well known
anesthetic acts on receptors in the spine (NMDA receptors), which are implied in the
occurrence of chronic pain. The mechanism is called central sensation. It is known that
Ketamine reduces immediate postoperative pain, but its effectiveness in the prevention of the
chronic pain is still unknown. The investigators study will follow patients until one year
after operation for the occurrence of chronic pain. The investigators hypothesis is that
Ketamine reduces significantly chronic postoperative pain after major back surgery and
improves patient outcome.
There may be important inter-individual differences how persons react on a drug. These
differences are partly determined by the genes of each individual. The investigators study
includes therefore a genetic analysis.
Psychological and social factors also influence the perception of pain. It is still not well
understood who these "psychosocial factors" determine the appearance and perception of
chronic pain. In the investigators study the investigators will therefore study these factors
by questionnaires.
2 Interventions
Name: Placebo
Description: 50 ml syringes provided by the HUG pharmacy will contain 1% ketamine or 0.9% NaCl. After induction and before start of surgery, patients will receive an intravenous bolus of 0.025 ml/kg of the study solution (corresponding to 0.25 mg/kg ketamine). Maintenance will be with a syringe driver at a rate of 0.025 ml/kg/h (corresponding to 0.25 mg/kg/h ketamine) until one hour before the end of surgery, and will then be decreased to a rate of 0.01 ml/kg/h (corresponding to 0.1 mg/kg/h ketamine) throughout the stay in the recovery room (usually 2 to 3 hours). The infusion will be stopped when the patient leaves the recovery room.
Type: Drug
Group Labels: 1 Physiologic saline
Name: Ketamine
Description: 50 ml syringes provided by the HUG pharmacy will contain 1% ketamine or 0.9% NaCl. After induction and before start of surgery, patients will receive an intravenous bolus of 0.025 ml/kg of the study solution (corresponding to 0.25 mg/kg ketamine). Maintenance will be with a syringe driver at a rate of 0.025 ml/kg/h (corresponding to 0.25 mg/kg/h ketamine) until one hour before the end of surgery, and will then be decreased to a rate of 0.01 ml/kg/h (corresponding to 0.1 mg/kg/h ketamine) throughout the stay in the recovery room (usually 2 to 3 hours). The infusion will be stopped when the patient leaves the recovery room.
Type: Drug
Primary Outcomes
Measure: To evaluate the long-term (6 and 12 months) effect of perioperative intravenous low-dose ketamine on chronic neuropathic pain in patients undergoing major back surgery. Time: one year
Secondary Outcomes
Measure: To evaluate the short-term (during hospitalisation) effect of perioperative intravenous low-dose ketamine in patients undergoing major back surgery: tolerability and safety, opioid-sparing effect, pain intensity, morphine-related adverse effects. Time: one week
Measure: To study the potential impact of genetic variability of several enzymes (CYP2D6, CYP2C9, COMT) known to modulate pain sensitivity and/or metabolism of opioid and NSAIDs on analgesic consumption and ketamine response. Time: immediate
Measure: To study psychosocial factors that may be involved in the perception of acute and chronic postoperative pain in patients with or without chronic back pain undergoing back surgery. Time: one year
Measure: To study the pharmakokinetics of an intravenous low-dose ketamine infusion. Time: one day
Purpose: Prevention
Allocation: Randomized
Single Group Assignment
There is one SNP
SNPs
1 V158M
As for pain sensitivity and morphine response
variability, the met allele at the val158met polymorphisms in the
catechol-O-methyltransferase gene (COMT), reduces the ability of the enzyme to
metabolize catecholamines, and has been associated with a decrease in opioid consumption
in cancer pain patients. --- val158met ---