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

NCT ID: NCT04956237

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2024-02-29

Brief 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.

Conditions

Retinal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tenonian surgery

Hospital recruitment with outpatient surgery without the presence of an anesthesiologist, without loco-regional anesthesia and without intravenous route

No interventions assigned to this group

Peribulbar surgery

Gold standard: City recruitment with outpatient surgery with the presence of an anesthesiologist and with loco-regional anesthesia

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Pierre Cherest

Neuilly-sur-Seine, , France

Foch Hospital

Suresnes, , France

Countries

France

Other Identifiers

2020_0138

Identifier Type: -

Identifier Source: org_study_id