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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Ketamine

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.