Patients scheduled for elective, posterior lumbar-instrumented spinal surgery +/- decompression. Surgery
Conditions
Interventions
Patients will be identified and screened for eligibility by their surgical clinical team when the decision for lumbar spinal surgery has been taken. Patients will be provided with written information
(2) Intrathecal Opioids (ITO)
(3) Erector Spinae plane Block (ESB) using the Sheffield CTRU online randomisation system (SCRAM). Participants will be allocated to their intervention using minimisation with a random element and the
levels of fusion (1 level vs. >1 level (2-3)), receiving Step 3 opioid therapy at randomisation (yes vs no). Trial participants can only be randomised if staff trained in delivery of all interventions
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/02/2025: 1. People aged 16 years or over. 2. Scheduled for elective, posterior lumbar-instrumented spinal surgery +/- decompression (including patients undergoing this surgery following a previous lumbar discectomy or decompression). 3. Able to give informed consent, with interpreters provided where necessary. _____ Previous 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
Exclusion criteria: Current exclusion criteria as of 26/02/2025: 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 only. 7. Patients undergoing anterior surgery. 8. Patients who have previously had posterior lumbar instrumentation. Current pregnancy: a pregnancy test, in the female patients of childbearing age is routine immediately prior to surgery. _____ Previous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcomes 1. Pain scores (VAS) 13 back & leg pain, at rest and movement, on a 0-100 scale; 2. EQ-5D-5L14: Health status questionnaire used to derive quality adjusted life year (QALYs) and used in the cost-effectiveness analysis; 3. Quality of Recovery Questionnaire (QoR-15) 15 to measure the quality of recovery after surgery and analgesia; 4. Healthcare Resource Use: measured using a bespoke questionnaire. 5. Oswestry Disability Index16 to measure functional recovery after surgery Clinical 1. Cumulative opioid consumption after surgery, at 24 hours and 72 hours (or discharge) (converted to oral morphine equivalent) 2. Adverse events 3.Intervention-related side-effects (including: Postoperative Nausea and Vomiting (PONV), pruritus, respiratory depression (respiratory rate <8 breaths/minute) 4. Further clinical intervention such as: antiemetic administration, urinary catheterisation, High Dependency Care/Intensive Care admission 5. Time to mobilisation after surgery 6. Length of hospital stay (readiness for discharge) 7. Readmissions between discharge and routine 6-8 week postoperative follow up. | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed