Pain relief after instrumented spinal surgery trial

Phase 3

• Conditions: Patients scheduled for elective, posterior lumbar-instrumented spinal surgery +/- decompression.; Surgery

• Registration Number: ISRCTN37852146
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-03
• Last Update Posted: 2 September 2024
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 456

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Back pain on moving around the bed (sitting up and/or turning) from Visual Analog Scale (VAS) recorded at 24 hours after surgery, reported using a 10 cm line, 0-100 score. Patients unable to sit up and/or turn as a result of pain will be assigned the highest pain score (100).