Status:
COMPLETED
The Effect of Perioperative Ketamine on Acute and Chronic Pain After Major Back Surgery
Lead Sponsor:
University Hospital, Geneva
Conditions:
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pai...
Detailed Description
Background 1. Ketamine as an adjuvant to multimodal postoperative analgesia and its impact on the development of chronic neuropathic pain: Ketamine, a phenylcyclidine derivate, was developed in t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00618423
Start Date
October 1 2007
End Date
March 1 2013
Last Update
April 15 2013
Active Locations (1)
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1
University Hospital of Geneva
Geneva, Canton of Geneva, Switzerland, 1211