CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Bupivacaine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04156581
NCT04156581Phase 4Completed

Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery: A Randomized Controlled Trial

Hospital for Special Surgery, New York·interventional·Posted Nov 7, 2019·Updated Dec 27, 2024

In Brief

A Phase 4 clinical trial evaluating Bupivacaine, Dexamethasone, and 1 other intervention for Opioid Use and Pain, Postoperative. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 7, 2019
Enrollment StartNov 19, 2019
Primary CompletionJun 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.7 years ago

Interventions

Bupivacainedrug

Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.

Dexamethasonedrug

Dexamethasone is a corticosteroid that reduces inflammation.

Salineother

Saline is a mixture of NaCl and water that can be used as a placebo.