The Effect of Perioperative Ketamine on Acute and Chronic Pain After Major Back Surgery (KetaDol)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Czarnetzki, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00618423
First received: February 6, 2008
Last updated: April 12, 2013
Last verified: April 2013
  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. 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.


Condition Intervention Phase
Postoperative Pain
Drug: Placebo
Drug: Ketamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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 ]

Enrollment: 160
Study Start Date: October 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Physiologic saline 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.
Active Comparator: Ketamine 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.
Other Name: Ketalar®

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
University Hospital of Geneva
Geneva, Canton of Geneva, Switzerland, 1211
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: Christoph Czarnetzki, Responsable Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00618423     History of Changes
Other Study ID Numbers: NAC 07-023 (07-006), Swissmedic 2007 DR 2198
Study First Received: February 6, 2008
Last Updated: April 12, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Neuropathic pain
Chronic pain
Acute postoperative pain
Ketamine
Back surgery
Anesthesia
Perioperative

Additional relevant MeSH terms:
Neuralgia
Pain, Postoperative
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014