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Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery. | Clinical Trials | Clareo Health

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Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.

NCT05015036•GCS Ramsay Santé pour l'Enseignement et la Recherche

Summary

Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme. The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).

Detailed Description

On a population of patients undergoing minimally invasive lumbar spine surgery divided into two cohorts of equal size according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme: Primary objective To compare the percentage of therapeutic success achieved in each group one month after surgery. Secondary objectives: to compare between groups: * Postoperative pain intensity at D1 and M1 * Analgesic consumption (in stages) at D1 and M1 * Pain-free walking distance at M1 * Surgery conditions (duration of operation, duration of hospitalisation) * Frequency of adverse events related to surgery (infection rate, 1 month recovery rate, transfusion requirements) * Emotional impact of the management

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult male or female (18 years or older)
•Patient who has agreed to participate in the study and has read and signed the consent form for participation in the study
•Patient for whom a minimally invasive spine surgery is planned: (dicectomy, lumbar canal recalibration with or without laminectomy, lumbar arthrodesis by posterior approach limited to one stage)

Exclusion Criteria

•Patient with a contraindication to spinal anaesthesia
•A bedridden or institutionalised patient
•Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
•Patient not affiliated to the French social security system
•Patient under legal protection, guardianship or curatorship
•Patient already included in another therapeutic study protocol

Locations (1)

Clinique Geoffroy Saint-Hilaire

Paris, France

Key Dates

Start Date

February 28, 2022

Primary Completion Date

September 7, 2023

Completion Date

September 7, 2023

Last Updated

July 3, 2024

Enrollment

100

ACTUAL participants

Conditions

Spine Surgery

Interventions

ERAS

PROCEDURE

Minimally invasive surgery

PROCEDURE

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RECRUITING

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.

Inclusion Criteria

Exclusion Criteria

An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Irrisept Solution for Instrumented Spine Surgery

Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery

Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring

Prevalence and Surgical Implications of the Arcuate Foramen: A 3D CT-Based Observational Study