Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

NCT06830070 — Active not recruiting, 70 participants, Prim. Prof. Dr. Oliver Findl, MBA

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Registry	NCT06830070
Status	Active not recruiting
Study type	Observational
Enrollment	70 (Actual)
Sponsor	Prim. Prof. Dr. Oliver Findl, MBA (Other)
Conditions	Epiretinal Membranes, Retinal Detachment, Full Thickness Macular Hole
Interventions	subjective pain score assessment (Other)
Dates	start 2023-12-13, primary completion 2025-05-31 (estimated), completion 2025-05-31 (estimated), first posted 2025-02-17, last updated 2025-02-20
Locations	1 site in Austria

-Summary

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
vitreoretinal surface diseases		Other: subjective pain score assessment	patients with the indications epiretinal membranes or full thickness macular holes are belonging to the Group of vitreoretnal surface diseases
retinal detachment		Other: subjective pain score assessment	patients with the indication retinal detachment are belonging to this group

subjective pain score assessment (Other): a questionnaire assessing subjective pain during surgery, using the Visual Analogue Scale with values from 0 to 10

+Outcome measures

Primary outcomes

subjective pain score during surgery [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Vienna Institute for Research in Ocular Surgery	Vienna	Austria

+Publications

El-Hindy N, Johnston RL, Jaycock P, Eke T, Braga AJ, Tole DM, Galloway P, Sparrow JM; UK EPR user group. The Cataract National Dataset Electronic Multi-centre Audit of 55,567 operations: anaesthetic techniques and complications. Eye (Lond). 2009 Jan;23(1):50-5. doi: 10.1038/sj.eye.6703031. Epub 2008 Mar 14. PMID 18344970
Lai MM, Lai JC, Lee WH, Huang JJ, Patel S, Ying HS, Melia M, Haller JA, Handa JT. Comparison of retrobulbar and sub-Tenon's capsule injection of local anesthetic in vitreoretinal surgery. Ophthalmology. 2005 Apr;112(4):574-9. doi: 10.1016/j.ophtha.2004.10.043. PMID 15808246
Friedberg MA, Spellman FA, Pilkerton AR, Perraut LE Jr, Stephens RF. An alternative technique of local anesthesia for vitreoretinal surgery. Arch Ophthalmol. 1991 Nov;109(11):1615-6. doi: 10.1001/archopht.1991.01080110153055. PMID 1845110

+Investigators

Oliver Findl, Study chair, Vienna Institute for Research in Ocular Surgery