ISRCTN37852146
Active, not recruiting
Phase 3
Pain Relief After Instrumented Spinal surgEry trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Patients scheduled for elective, posterior lumbar-instrumented spinal surgery +/- decompression.
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Enrollment
- 456
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. People aged 16 years or over
- •2\. Scheduled for elective, posterior lumbar\-instrumented spinal surgery \+/\- decompression
- •3\. Able to give informed consent, with interpreters provided where necessary
Exclusion Criteria
- •1\. Patients with drug sensitivity or allergy to any of the trial agents i.e. intrathecal opioid or local anaesthetic
- •2\. Patients undergoing fusion at more than three vertebral levels
- •3\. Patients with an infection or tumour at the block site or surgical site
- •4\. Patients meeting criteria for American Society of Anaesthesiologists Physical Status Classification Grade 4\-5
- •5\. Patients undergoing surgery during an emergency admission (this would preclude a detailed risk\-benefit conversation with a consultant anaesthetist, which our PPI group told us was vital pre\-consent).
- •6\. Patients scheduled for single\-level microdiscectomy and decompression.
- •7\. Current pregnancy
Outcomes
Primary Outcomes
Not specified
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