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NCT03902925
Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia
Phase 1, PHASE2 trial testing Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection in Retinal Disease in 56 participants. Completed in 31 October 2019.
31 August 2019
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 January 2019 |
| Primary completion | 31 August 2019 |
| Estimated completion | 31 October 2019 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection
- Peribulbar injection
Conditions studied
- Retinal Disease — all drugs for Retinal Disease →
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
- Maculopathy — all drugs for Maculopathy →
Sponsor
University of Sao Paulo
Who can join
18 and older, any sex, with Retinal Disease or Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vitreoretinal surgery has evolved to less invasive procedures, and it is used to treat a wide range of diseases. So anesthesia for vitreoretinal procedures has evolved, promoting adequate analgesia while reducing risks to the patient. In the present study two types of procedures for anesthesia during vitreoretinal surgery are evaluated regarding the pain referred by the patient during the whole procedure: peribulbar anesthesia versus sub-tenon injection plus topical jelly anesthesia. Through the comparative analysis of the pain scale of the two groups it is expected that the two modalities present the same anesthetic efficacy, showing that the methods used may be equivalent.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pain during pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia: A randomized trial.
Ribeiro JAS, Ribeiro DS, Scott IU, Abrão J, et al · · 2020 · cited 11× · PMID 32760093 · DOI 10.1371/journal.pone.0236624
Verify or expand the search:
- PubMed search for NCT03902925
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03902925 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 4 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03902925.
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