Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Completed

• Conditions: Cervical Foraminal Stenosis

• Registration Number: NCT05326698
• Lead Sponsor: Centre Hospitalier Régional de la Citadelle

Brief Summary

Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Study Start: 2022-02-22
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-24
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-09
• Last Update Submitted: 2022-04-09
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

1. Cervical radiculopathy due to foraminal stenosis
2. Age > 18 years
3. Radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months.
4. Persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.).
5. Intact Llemniscal pathways must remain at least partially intact

Exclusion Criteria

1. History of coagulation disorders; Lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; Morbus Bechterew; Active malignancy; immune deficiency
2. Presence of myelopathy
3. Addiction to drugs, alcohol (5 units/day) and/or medications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.	Through surgery completion, from electrodes placement until their removal. An average of two hours.	The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder.; The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back.; Somatosensory evoked potentials (SEP) were recorded continuously from electrode placement to electrode removal.; The blood pressure and the irrigation pressure in the endoscope are also continuously recorded.; A change SEP in latency and/or amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.
Influence of the endoscopic irrigation pressure on motor evoked potentials.	Through surgery completion, from electrodes placement until their removal. An average of two hours.	The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder.; The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back.; Motor evoked potentials (MEP) were recorded at each step of the surgery (preoperative, skin incision, working tube placement, endoscope introduction, and foraminotomy) and also at each variation of the irrigation pressure.; A change MEP amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.

Trial Locations

Locations (1)

CHR Citadelle; 🇧🇪 Liège, Belgium