Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery
Status unconfirmed · Phase 4
Conditions studied: Revision Spine Surgery, Fusion of Spine, Cervical Fusion, Lumbar Fusion
In brief
To determine if a pre-operative ketamine infusion would provide a similar decrease in post-operative analgesic and opioid consumption as intra-operative ketamine, but expand the monitoring period through the post-operative phase up to 90 days. Hypothesis is that pre-operative ketamine infusion will lead to a decrease in narcotic consumption from baseline following an elective cervical or lumbar fusion, leading to increased functionality and quality of life for these patients.
Key facts
- Study ID
- NCT06066879
- Run by
- AXIS Spine Center- a division of Northwest Specialty Hospital
- People needed
- 40
- Starts
- 2023-09-18
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2023-10-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, aged 18-75
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Daily opiate use totaling ≥50 morphine milli-equivalents (MME) or more for 6 weeks or greater
- Scheduled for revision surgical fusion of the cervical or lumbar spine
- Total duration of neck or back pain >12 weeks
You may not qualify if…
- Current use of Ketamine for any other medical conditions
- Uncontrolled hypertension
- Uncontrolled Diabetes
- Increased intracranial pressure
- Pregnancy or lactation
- Known allergic reactions to components of ketamine or midazolam
- Participants who ultimately require intra-operative ketamine administration for anesthesia
- Treatment with another investigational drug or other intervention within 12 months of study treatment
- History of psychosis or schizophrenia
- History of conversion disorder
- History of clotting disease
- Pending or active compensation claim, litigation or disability remuneration (secondary gain)
- Surgically naïve patients
- Allergies to any of the medications to be used during the procedures
- Active infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
- Uncontrolled immunosuppression (e.g. AIDS, cancer)
- Participating in another clinical trial/investigation within 30 days prior to signing informed consent
- Subject unwilling or unable to comply with follow up schedule or protocol requirements
Where it is running
- AXIS Spine — Coeur d'Alene, Idaho, United States (enrolling)
Full record on ClinicalTrials.gov
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