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NCT04156581 · ClinicalTrials.gov registry record · Phase 4
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT04156581: Completed Phase 4 study, sponsored by Hospital for Special Surgery, New York.
NCT04156581 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04156581, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study 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.
Primary Outcome
The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME).
Interventions
- DRUG Bupivacaine
- OTHER Saline
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2022-06-18 |
| Phase | Phase 4 |
What the finished NCT04156581 record still lists
NCT04156581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Bupivacaine is the first listed.
NCT04156581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04156581 about?
NCT04156581 is a clinical study titled "Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery". 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 Sp...
What is the current status of trial NCT04156581?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2019-11-19. Estimated completion is 2022-06-18.
What interventions are being tested in trial NCT04156581?
The interventions under investigation include: Bupivacaine (DRUG), Saline (OTHER), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT04156581?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04156581's enrollment target sits among peer trials
46 1348th of 2000 higher than 647 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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