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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04956237
Acronym
Retine-Foch
Enrollment
164
Registered
2021-07-09
Start date
2021-09-09
Completion date
2024-02-29
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Disease

Keywords

Peribulbar surgery, Tenonian surgery, Retinal surgery, Surgeon comfort, Patient comfort

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.

Interventions

None listed

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesiaAt the surgeryNumber of eye or head movements of the patient during the operation

Secondary

MeasureTime frameDescription
Comparison of the patient's comfort during the operation between the 2 groups15 minutes after the end of the surgeryPostoperative 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 painPreoperative, peroperative and 15 minutes post surgeryVisual 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 groupsAt the end of the surgeryOperating time
Assessement of the security between the 2 groupsAt the end of the surgeryIntraoperative complications and peroperative events

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026