About the Trial 

Research Question

Which approach to post-operative pain relief is most effective after elective posterior lumbar instrumented spinal surgery: usual care, intrathecal opioids or Erector Spinae Plane Block? 

Our Aim 

To evaluate the clinical and cost-effectiveness of three different pain management approaches following lumbar spine surgery, helping to improve patient recovery and post-operative care 

 Study design 

This is a multicentre, parallel-group, superiority trial using a patient-blinded,  individual participant randomised controlled design. 

Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: usual care (UC), usual care plus intrathecal opioid (ITO), or usual care plus Erector Spinae Plane (ESP) block. 

Intervention 1: Usual care 

Multimodal pain relief as per standard care after spinal surgery +/- decompression. Analgesia is administered at the time of surgery whilst under General Anaesthesia e.g. intravenous opioid, Paracetamol, NSAID, administered intra-operatively at discretion of local anaesthetist. Local Wound Infiltration of surgical incision with Local Anaesthetic (levo-bupivacaine) at surgical closure by operating surgeon. 

 Intervention 2: Intrathecal Opioid (ITO)

Usual Care plus Intrathecal Opioid injection at the time of surgery (or prior, where local standard of care) whilst under GA . Local infiltration of surgical incision with Local Anaesthetic. Administered by operating surgeon, or anaesthetist prior to wound closure, via intrathecal injection under direct vision. Preservative free morphine (minimum dose 0.1mg) or diamorphine (0.2mg to 0.4mg dose) permitted, directed by local practice and requirements for post-operative care.

Intervention 3: Erector Spinae Plane (ESP) block

Usual Care plus Erector Spinae plane Block. No local wound infiltration. Regional “field” block with local anaesthetic, provided by anaesthetist/anaesthetist practitioner having completed trial ESP block training or a trial-trained anaesthetist/anaesthetist practitioner already performing ESP blocks as per local standard of care. Administered via ultrasound-guided injection to produce bilateral “fascial plane” blocks, at completion of surgery after wound closure, prior to emergence from anaesthesia. Dose: 2 x 20ml Levo-bupivacaine 0.25% (2.5mg/ml): 40mls (100mg) in total; modification protocol if patient weight <50kg (see PRAISE protocol).

Primary outcome

Primary outcome is VAS back pain on movement around the bed (sitting up and/or turning) on a 0-100 VAS at 24 hours post-surgery. 

Secondary outcome

Secondary outcomes include:

• VAS back pain at rest

• VAS back pain on walking

• VAS leg pain on movement

• EQ-5D-5L

• Quality of Recovery Questionnaire (QoR-15)

• Healthcare Resource Use

• Oswestry Disability Index

• Cumulative opioid consumption post-surgery

• Adverse events

• Intervention-related side-effects

• Further clinical intervention

• Time to mobilisation after surgery

• Length of hospital stay

Study Timeline 

Recruitment Start Date: October 2024

Recruitment End Date: November 2025

Follow-up Duration: 6-8 weeks post-surgery 

ESP Block Training 

A training package for anaesthetists in ESP block techniques has been developed by Professor Graeme McLeod at the University of Dundee. This program includes video-based instructions alongside hands-on practice procedures, which will be assessed and evaluated by ESP block experts. If you will be working on the trial at one of our participating organisation and are interested in completing this training, please contact us.