Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

February 18, 2025 updated by: Prim. Prof. Dr. Oliver Findl, MBA
Subtenonal anesthesia is a well-known technique of local anesthesia for patients undergoing pars plana vitrectomies. It was described to be efficient with respect to anesthesia of the eye and it showed less risks compared to retrobulbar or parabulbar anesthesia. Purpose of the study is to assess subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Subtenonal anesthesia is a well-known technique of local anesthesia for patients undergoing pars plana vitrectomies. It was described to be efficient with respect to anesthesia of the eye and it showed less risks compared to retrobulbar or parabulbar anesthesia. Subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia, are probably different among patients with excessive indentation of the bulbus for retinal detachment repair, compared to patients undergoing vitrectomy with membrane peeling for epiretinal membranes or full thickness macular holes. Purpose of the study is to assess subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients having undergone vitrectomy in subtenon´s anesthesia

Description

Inclusion criteria

  • Vitrectomy with subtenonal anesthesia in the time-period from 1.12.2022 to 31.8.2023
  • Indication for surgery: retinal detachment, epiretinal membrane, or full thickness macular hole
  • Questionnaire for subtenonal anesthesia was already answered by the patients
  • Age 18 and older

Exclusion criteria

Any of the following will exclude a subject from the study:

  • Surgery in general anesthesia
  • Questionnaire missing or incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vitreoretinal surface diseases
patients with the indications epiretinal membranes or full thickness macular holes are belonging to the Group of vitreoretnal surface diseases
Other: subjective pain score assessment
a questionnaire assessing subjective pain during surgery, using the Visual Analogue Scale with values from 0 to 10
retinal detachment
patients with the indication retinal detachment are belonging to this group
Other: subjective pain score assessment
a questionnaire assessing subjective pain during surgery, using the Visual Analogue Scale with values from 0 to 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective pain score during surgery
Time Frame: assessed within 24 hours sfter surgery
subjective pain score during surgery are assessed with Visual Analogue Scale from 0 to 10. The value of 0 represents no pain and the value of 10 represents the highest pain that can be imagined.
assessed within 24 hours sfter surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Investigators

  • Study Chair: Oliver Findl, Vienna Institute for Research in Ocular Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPS (sponsor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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