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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04956237
Other study ID # 2020_0138
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 9, 2021
Est. completion date March 2023

Study information

Verified date February 2023
Source Hopital Foch
Contact Vincent Pierre-Kahn, PhD
Phone 01 46 25 40 96
Email v.pierre-kahn@hopital-foch.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head. Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist. The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route. To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia. This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route. For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 years old - Patients with an indication for retinal surgery - Not having opposed to participate in the study Exclusion Criteria: - Claustrophobia - Unbalanced psychiatric pathology - Inability to lie down - Deprived of liberty or under guardianship.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Clinique Pierre Cherest Neuilly-sur-Seine
France Foch Hospital Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia Number of eye or head movements of the patient during the operation At the surgery
Secondary Comparison of the patient's comfort during the operation between the 2 groups Postoperative Iowa Satisfaction with Anesthesia Scale (ISAS) Score rated from 11 (worse outcome) to 66 (better outcome) 15 minutes after the end of the surgery
Secondary Comparison of the patient's comfort during the operation between the 2 groups regarding pain Visual analogic scale (VAS) of pain during the surgery rated from 0 "No pain" to 10 "worst possible pain" Preoperative, peroperative and 15 minutes post surgery
Secondary Comparison of operating time between the 2 groups Operating time At the end of the surgery
Secondary Assessement of the security between the 2 groups Intraoperative complications and peroperative events At the end of the surgery
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