Retine-Foch: Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Tenonian surgery Hospital recruitment with outpatient surgery without the presence of an anesthesiologist, without loco-regional anesthesia and without intravenous route |
|
| Peribulbar surgery Gold standard: City recruitment with outpatient surgery with the presence of an anesthesiologist and with loco-regional anesthesia |
Outcome Measures
Primary Outcome Measures
- Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia [At the surgery]
Number of eye or head movements of the patient during the operation
Secondary Outcome Measures
- Comparison of the patient's comfort during the operation between the 2 groups [15 minutes after the end of the surgery]
Postoperative Iowa Satisfaction with Anesthesia Scale (ISAS) Score rated from 11 (worse outcome) to 66 (better outcome)
- Comparison of the patient's comfort during the operation between the 2 groups regarding pain [Preoperative, peroperative and 15 minutes post surgery]
Visual analogic scale (VAS) of pain during the surgery rated from 0 "No pain" to 10 "worst possible pain"
- Comparison of operating time between the 2 groups [At the end of the surgery]
Operating time
- Assessement of the security between the 2 groups [At the end of the surgery]
Intraoperative complications and peroperative events
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Pierre Cherest | Neuilly-sur-Seine | France | 92200 | |
| 2 | Foch Hospital | Suresnes | France | 92150 |
Sponsors and Collaborators
- Hopital Foch
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020_0138