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Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

NCT04156581 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-27

Study results available
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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.

Conditions

  • Opioid Use
  • Pain, Postoperative

Interventions

DRUG

Bupivacaine

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

DRUG

Dexamethasone

Dexamethasone is a corticosteroid that reduces inflammation.

OTHER

Saline

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

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Ellen Soffin, MD, PhD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2022-06-18
Completion
2022-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04156581 on ClinicalTrials.gov