Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort

Retinal Disease Clinical Trial

— Retine-Foch  

Official title:

Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956237
• Other study ID #: 2020_0138
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Retinal Disease
• Retinal Diseases

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