Phase 4
Completed N=46
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
Opioid Use Disorder · Pain, Postoperative
Source: ClinicalTrials.gov NCT04156581 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Intraoperative and Postoperative Opioid Consumption — 191; 139.4 MME/day
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery. Although ERPs for spine surgery are now being described, few pathways include regional analgesia. The Erector Spinae Plane Block (ESPB) may represent a novel opportunity to incorporate regional analgesia into ERPs for spine surgery. To date, there is minimal data to support the utility of ESPB in spine surgery, and this block has not yet been evaluated in complex spine surgery.
This study seeks to see whether ESPB will reduce opioid consumption and pain scores, and improve patient recovery during the first 24 hours after complex spine surgery when included in a comprehensive ERP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative and Postoperative Opioid Consumption |
191; 139.4 | — |
| SECONDARY Numeric Rating Scale Pain at Rest |
2.74; 3.04; 3.56; 4.15; 3.33; 3.9 | — |
| SECONDARY Pain Scores With Physical Therapy |
3; 2; 4.29; 3.9; 4.94; 3.53 | — |
| SECONDARY Quality of Recovery |
101.36; 99.45; 69.85; 74.73; 79.67; 79.82 | — |
| SECONDARY Opioid Related Side Effects |
2.56; 2.24 | — |
| SECONDARY Blinding Assessment |
.045; -0.048; 0.318; -0.045; 0.381; -0.429 | — |
| SECONDARY Time to First Opioid Use Via Intravenous Administration |
237.73; 286.23 | — |
| SECONDARY Time to Opioid Consumption Via Oral Administration |
254.62; 141.09 | — |
| SECONDARY Total Opioid Consumption |
21.83; 25.48 | — |
| SECONDARY 24 Hours Post-operative Opioid Consumption |
42.9; 47.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-80
- Planned primary complex spine surgery: >2 level- lumbar and/or thoraco-lumbar spine fusion with or without decompression
- Planned stand-alone posterior surgical approach
- Able to follow study protocol
- Able to communicate in English (outcome questionnaires validated in English)
Exclusion Criteria
- Age 80
- Revision surgery
- BMI > 35
- planned prolonged intubation/intubation overnight on night of surgery
- Unable to communicate in English
- History of chronic pain condition requiring gabapentin/pregabalin/antidepressant medication longer than 3 months
- Opioid tolerance (>60 OME daily for >2 weeks)
- Allergy, intolerance or contraindication to any protocol component/study medication/technique
- Patient refusal of regional analgesia (ESPB)
Data sourced from ClinicalTrials.gov (NCT04156581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.