NCT00618423

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2 postoperative-pain

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

5.4 years

First QC Date

February 6, 2008

Last Update Submit

April 12, 2013

Conditions

Postoperative Pain

Keywords

Neuropathic painChronic painAcute postoperative painKetamineBack surgeryAnesthesiaPerioperative

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (4)

  • 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.

    one week

  • 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.

    immediate

  • 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.

    one year

  • To study the pharmakokinetics of an intravenous low-dose ketamine infusion.

    one day

Study Arms (2)

Physiologic saline

PLACEBO COMPARATOR
Drug: Placebo

Ketamine

ACTIVE COMPARATOR
Drug: Ketamine

Interventions

PlaceboDRUG

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.

Physiologic saline
KetamineDRUG

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.

Also known as: Ketalar®
Ketamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Czarnetzki C, Desmeules J, Tessitore E, Faundez A, Chabert J, Daali Y, Fournier R, Dupuis-Lozeron E, Cedraschi C, Richard Tramer M. Perioperative intravenous low-dose ketamine for neuropathic pain after major lower back surgery: A randomized, placebo-controlled study. Eur J Pain. 2020 Mar;24(3):555-567. doi: 10.1002/ejp.1507. Epub 2019 Dec 9.

    PMID: 31743533DERIVED

MeSH Terms

Conditions

Pain, PostoperativeNeuralgiaChronic Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Martin Tramèr, Prof, MD, PhD

    anesthesia department

    STUDY CHAIR

  • Christoph A Czarnetzki, MD, MBA

    anesthesia department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsable Investigator

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

CH(1)