Skip to main content
OpenTrials
Completed

NCT Number: NCT04956237

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pierre Cherest, Neuilly-sur-Seine, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: At the surgery

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

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: 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"

  3. Comparison of operating time between the 2 groups

    Time frame: At the end of the surgery

    Operating time

  4. Assessement of the security between the 2 groups

    Time frame: At the end of the surgery

    Intraoperative complications and peroperative events

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Retine-Foch

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.