Clinical trial NCT04956237: Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort
Official title: Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Disease
Keywords: Peribulbar surgery
Tenonian surgery
Retinal surgery
Surgeon comfort
Patient comfort
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient over 18 years of age undergoing retinal surgery including retinal detachment, epi-retinal membrane-internal limiting peel, macular hole, implant dislocation, vitrectomy, revision of capsular rupture

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.


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.

Primary outcomes:
measure: Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia
timeFrame: At the surgery
Secondary outcomes:
measure: Comparison of the patient's comfort during the operation between the 2 groups
timeFrame: 15 minutes after the end of the surgery
measure: Comparison of the patient's comfort during the operation between the 2 groups regarding pain
timeFrame: Preoperative, peroperative and 15 minutes post surgery
measure: Comparison of operating time between the 2 groups
timeFrame: At the end of the surgery
measure: Assessement of the security between the 2 groups
timeFrame: At the end of the surgery
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Clinique Pierre Cherest
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
References: