TEASER: Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT05762159

Collaborator

(none)

Enrollment

Location

7.8

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Other: data collected

Detailed Description

Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Actual Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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)

Arm

Intervention/Treatment

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

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)

Outcome Measures

Primary Outcome Measures

variation of the pupil size (in percentage) [During the surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients receiving erector spinae block for pain management of spinal osteosynthesis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Maxime Wodey, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT05762159

Other Study ID Numbers:

IRBN1272022/CHUSTE

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 15, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

spinal erector block

pupillometry

loco-regional anesthesia

osteosynthesis

Study Results

No Results Posted as of Mar 15, 2023