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Clinical Trials/ISRCTN37852146
ISRCTN37852146
Active, not recruiting
Phase 3

Pain Relief After Instrumented Spinal surgEry trial

Sheffield Teaching Hospitals NHS Foundation Trust0 sites456 target enrollmentNovember 3, 2023

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.

Registry
who.int
Start Date
November 3, 2023
End Date
August 31, 2026
Last Updated
last year
Study Type
Interventional
Sex
All

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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