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Erector Spinae Block vs Morphine in Vertebral Fixation

NCT04729049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-07

No results posted yet for this study

Summary

The study aims to shed light about the potential role of Erector Spinae Block in the management of postoperative pain following vertebral fixation surgery via posterior approach. Patients will be randomized, the block will be performed before inducing general anesthesia, intraoperative management will be uniformed, while postoperative analgesia will compare cases (patients who received the block) versus controls (usual care with endovenous morphine infusion only).

Conditions

  • Vertebral Subluxation
  • Spine Disease
  • Spondylolisthesis

Interventions

PROCEDURE

Erector Spinae plane Block

Ultrasound-guided interfascial technique, aiming to block the anterior and posterior branches of the spinal nerves for multi-dermatomal analgesia. Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve a craniocaudal distribution along several vertebral levels.

DRUG

Patient controlled analgesia with intravenous morphine

Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).

Sponsors & Collaborators

  • AUSL Romagna Rimini

    lead OTHER

Principal Investigators

  • Domenico P Santonastaso, MD · AUSL Romagna - Ospedale Bufalini di Cesena

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Italy

Study Locations

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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 NCT04729049 on ClinicalTrials.gov