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

NCT04956237 | Completed

• 1 other identifier: 2020_0138
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 2

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

Keywords

Peribulbar surgery; Tenonian surgery; Retinal surgery; Surgeon comfort; Patient comfort

Outcome Measures

Primary Outcomes (1)

• Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia

  Number of eye or head movements of the patient during the operation

  At the surgery

Secondary Outcomes (4)

• Comparison of the patient's comfort during the operation between the 2 groups

  15 minutes after the end of the surgery

• Comparison of the patient's comfort during the operation between the 2 groups regarding pain

  Preoperative, peroperative and 15 minutes post surgery

• Comparison of operating time between the 2 groups

  At the end of the surgery

• Assessement of the security between the 2 groups

  At the end of the surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients over 18 years old
• Patients with an indication for retinal surgery
• Not having opposed to participate in the study

You may not qualify if:

• Claustrophobia
• Unbalanced psychiatric pathology
• Inability to lie down
• Deprived of liberty or under guardianship.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

Clinique Pierre Cherest

Neuilly-sur-Seine, 92200, France

Location

Foch Hospital

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: September 9, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

FR (2)