Clinical Trials Directory

Trials / Completed

CompletedNCT04956237

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

Status
Completed
Phase
Study type
Observational
Enrollment
164 (actual)
Sponsor
Hopital Foch · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2021-09-09
Primary completion
2024-02-29
Completion
2024-02-29
First posted
2021-07-09
Last updated
2024-07-31

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04956237. Inclusion in this directory is not an endorsement.