Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

NCT05762159 | Completed

• 1 other identifier: IRBN1272022/CHUSTE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity. This information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.

Conditions

Anesthesia, Local

Keywords

spinal erector block; pupillometry; loco-regional anesthesia; osteosynthesis

Outcome Measures

Primary Outcomes (1)

• variation of the pupil size (in percentage)

  Evaluation the territory covered by the spinal erector block by variation of the pupil size (in percentage). Variation of the pupil size on stimulation will allow to deduce if the dermatome is covered by the spinal erector block analgesia.

  During the surgery

Study Arms (1)

erector spinae block

Patients receiving erector spinae block for pain management of spinal osteosynthesis. Pupillometer will be realized during analgesia (usual practice).

Other: data collected

Interventions

data collected OTHER

data collected: * Morphological data of the patients * Data of the erector block realization * Pupillometric data :the variation of the pupil size on stimulation (in percentage of the base diameter)

erector spinae block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving erector spinae block for pain management of spinal osteosynthesis will be included.

You may qualify if:

• Patients receiving erector spinae block for pain management of spinal osteosynthesis

You may not qualify if:

• Patient refusal
• Known allergy to local anesthetics
• Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)
• Technical impossibility to perform a spinal erector block
• Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma
• Current treatment likely to alter pupillary dilation reflex to pain : antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine)
• Serious psychiatric history
• Drug abuse
• Pregnancy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Interventions

Routinely Collected Health Data

Intervention Hierarchy (Ancestors)

Health Care Surveys; Health Services Research; Health Planning; Health Care Economics and Organizations; Health Care Quality, Access, and Evaluation

Study Officials

• Maxime Wodey, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 9, 2023
• Study Start: March 10, 2023
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)