![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
University Hospital, Geneva |
---|---|
Information provided by: | University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00618423 |
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. Our study will follow patients until one year after operation for the occurrence of chronic pain. Our 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.
Our 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 our study the investigators will therefore study these factors by questionnaires.F
Condition | Intervention | Phase |
---|---|---|
Postoperative Pain |
Drug: Placebo Drug: Ketamine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Perioperative Intravenous Low-Dose Ketamine on Acute and Chronic Neuropathic Pain After Major Back Surgery. A Randomised, Placebo-Controlled, Double-Blind Study |
Estimated Enrollment: | 180 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Placebo Comparator |
Drug: Placebo
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.
|
B: Active Comparator |
Drug: Ketamine
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christoph A Czarnetzki, MD, MBA | : 0041223723311 ext 6858558 | christoph.czarnetzki@hcuge.ch |
Switzerland, Canton of Geneva | |
University Hospital of Geneva | Recruiting |
Geneva, Canton of Geneva, Switzerland, 1211 | |
Contact: Christoph A Czarnetzki, MD, MBA 0041223723311 ext 6858558 christoph.czarnetzki@hcuge.ch | |
Contact: Martin Tramer, MD, PhD 0041223723311 ext 6858621 martin.tramer@hcuge.ch | |
Principal Investigator: Christoph A Czarnetzki, MD, MBA | |
Sub-Investigator: Enrico Tessitore, MD | |
Sub-Investigator: Jules Desmeules, MD | |
Sub-Investigator: Christine Cedraschi, PhD | |
Sub-Investigator: Michel Rossier, PhD | |
Sub-Investigator: Christopher Lysakowski, MD | |
Sub-Investigator: Alexandre Faust, MD | |
Sub-Investigator: Roxane Fournier, MD | |
Sub-Investigator: Antonio Faundez, MD |
Study Chair: | Martin Tramèr, Prof, MD, PhD | Anesthesia Department |
Principal Investigator: | Christoph A Czarnetzki, MD, MBA | Anesthesia Department |
Responsible Party: | Division of Anesthesiology, University Hospitals of Geneva ( Dr. Christoph Czarnetzki ) |
Study ID Numbers: | NAC 07-023 (07-006), Swissmedic 2007 DR 2198 |
Study First Received: | February 6, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00618423 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Neuropathic pain Chronic pain Acute postoperative pain Ketamine |
Back surgery Anesthesia Perioperative |
Anesthetics, Intravenous Excitatory Amino Acids Neurotransmitter Agents Anesthetics Central Nervous System Depressants Pain Anesthetics, Dissociative |
Signs and Symptoms Postoperative Complications Anesthetics, General Ketamine Peripheral Nervous System Agents Analgesics Pain, Postoperative |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Pain Anesthetics, Dissociative Pharmacologic Actions Signs and Symptoms |
Pathologic Processes Postoperative Complications Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pain, Postoperative Excitatory Amino Acid Antagonists |