The Effect of Perioperative Ketamine on Acute and Chronic Pain After Major Back Surgery - Full Text View

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00618423

Purpose

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

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

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

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

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 Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 Frame: one week ] [ Designated as safety issue: Yes ]
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 Frame: immediate ] [ Designated as safety issue: No ]
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 Frame: one year ] [ Designated as safety issue: No ]
To study the pharmakokinetics of an intravenous low-dose ketamine infusion. [ Time Frame: one day ] [ Designated as safety issue: No ]

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.

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults, age ≥18 years, male or female
American Society of Anaesthesiology (ASA) status I-III.
Back surgery: laminectomy, lumbar arthrodesis (Posterior Lumbar Interbody Fusion - PLIF, Transforaminal Lumbar Interboby Fusion - TLIF, Postero-lateral Fusion, semi-rigid fixation).
Subjects who have signed and dated an informed consent to participate in the study during the pre-operative assessment.

Exclusion Criteria:

Coronary heart disease (unstable angina, MI within the last 6 months)
Glaucoma.
History of allergy or hypersensitivity to ketamine or morphine.
Dementia or inability to understand the study protocol.
Subjects who have taken any investigational drug or used an experimental medical device within 30 days before the start of the study or are currently enrolled in another investigational drug study.
Failed back surgery syndrome (i.e. an unfavourable condition of a patient following back or spine surgery).
Posttraumatic paraplegia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618423

Contacts

Contact: Christoph A Czarnetzki, MD, MBA

: 0041223723311 ext 6858558

christoph.czarnetzki@hcuge.ch

Locations

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

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Study Chair:	Martin Tramèr, Prof, MD, PhD	Anesthesia Department
Principal Investigator:	Christoph A Czarnetzki, MD, MBA	Anesthesia Department

More Information

No publications provided

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

Keywords provided by University Hospital, Geneva:

Neuropathic pain
Chronic pain
Acute postoperative pain
Ketamine

Back surgery
Anesthesia
Perioperative

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009