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Retinal DiseasePhase 1/2NCT03902925

Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

A Phase 1/2 study testing Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection and Peribulbar injection in people with Retinal Disease and Diabetic Retinopathy, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Disease, Diabetic Retinopathy, Maculopathy
What is being tested?
Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection and Peribulbar injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBrazil
Study dates
1 Jan 2019to 31 Oct 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients that have the diagnosis of epiretinal membrane, macular hole, complication of diabetic retinopathy such as vitreous hemorrhage or traction retinal detachment or other vitreomacular diseases that require treatment by pars plana vitrectomy.

Who cannot join

  • Previous pars plana vitrectomy in the studied eye.
  • Previous scleral buckle surgery
  • Uncontrolled arterial hypertension
  • Any ocular surgery performed in the studied eye in the previous three months
  • Medical or psychological condition that preclude study adherence

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • School of Medicine - Clinical Hospital

    Ribeirão Preto, São Paulo, 14049-900

Other trials in Brazil

About this study

Official title: Pain During Pars Plana Vitrectomy Comparing Peribulbar Anesthesia Versus Sub-tenon Injection Plus Topical Jelly Anesthesia

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.

Being tested
Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection, Peribulbar injection
Keywords
vitrectomy, anesthesia, retinal disease, Pain, diabetic retinopathy, maculopathy
Medical subject headings
Retinal Diseases, Diabetic Retinopathy, Macular Degeneration, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injectionProcedure or surgery

    Lidocaine 2% jelly applied to conjunctival fornices for 5 minutes then injection of 2-4 ml of ropivacaine 10% in the sub-tenon space with a blunt cannula through a temporal inferior incision

  • Peribulbar injectionProcedure or surgery

    Peribulbar injection of 4-6 ml of ropivacaine 10%

Study groups in NCT03902925
Study groupRoleWhat they receive
Group 1- Sub-tenon plus lidocaine jellyExperimentalPatients are going to be submitted to lidocaine 2% jelly topical anesthesia for 5 minutes then to sub-tenon injection of 2-4 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.
Receives: Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection
Group 2- peribulbarActive comparatorPatients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.
Receives: Procedure: Peribulbar injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

    Pain score referred by the patient measured with a Visual Analogue Scale (VAS). The VAS consists of ruler with 100 cm in length and scale from 0 to 100, where the numbers of this one are visible only in the side of the examiner. It is constructed from a metal ruler with a total length of one meter, supported by two transparent acrylic side supports and a sliding and movable metal weight on the metallic part of the ruler.

    Before the measurement of pain, the examiner will explain to the patients the functioning of the VAS. Each patient will be encouraged to pass the marker along the scale, with the help of the examiner. It will be made clear to him that point "0" is the point of the scale which represented "no pain", what is considered the better outcome, and point "100" corresponded to the most intense pain he could feel. The patient will be asked about: Intraoperative pain - the intensity of pain throughout the procedure.

    Measured: Once 30 minutes after the end of the vitrectomy surgery

Secondary outcomes (1)

  1. Surgical complications

    Surgical complications referred by the surgeon during vitrectomy

    Measured: Once At the end of vitrectomy surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Aug 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902925
Sponsor's protocol ID
ST anesthesia for PPV
Status last verified
Oct 2019
First submitted
2 Apr 2019
Last updated
4 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We intend to have patient data stored but not individually available for researches at other sites in order to preserve anonymity of the patient.

Publications

  • Tang S, Lai P, Lai M, Zou Y, Li J, Li S. Topical anesthesia in transconjunctival sutureless 25-gauge vitrectomy for macular-based disorders. Ophthalmologica. 2007;221(1):65-8. doi: 10.1159/000096526.

    PubMed 17183205

  • Stevens JD, Foss AJ, Hamilton AM. No-needle one-quadrant sub-tenon anaesthesia for panretinal photocoagulation. Eye (Lond). 1993;7 ( Pt 6):768-71. doi: 10.1038/eye.1993.180.

    PubMed 8119430

  • Spaeth G. Ophthalmic Surgery, Principles and Practice. Third Edition. Saunders, Philadelphia, 2003.

  • Sousa FAEF, Silva JA. Avaliação e mensuração da dor em contextos clínicos e de pesquisa. Rev. Dor, 2004;5(4):408-429.

  • Roman SJ, Chong Sit DA, Boureau CM, Auclin FX, Ullern MM. Sub-Tenon's anaesthesia: an efficient and safe technique. Br J Ophthalmol. 1997 Aug;81(8):673-6. doi: 10.1136/bjo.81.8.673.

    PubMed 9349156

  • Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x.

    PubMed 1015603

  • Rao GP, Wong D, Groenewald C, McGalliard JN, Jones A, Ridges PJ. Local anaesthesia for vitreoretinal surgery: a case-control study of 200 cases. Eye (Lond). 1998;12 ( Pt 3a):407-11. doi: 10.1038/eye.1998.96.

    PubMed 9775241

  • Theocharis IP, Alexandridou A, Tomic Z. A two-year prospective study comparing lidocaine 2% jelly versus peribulbar anaesthesia for 25G and 23G sutureless vitrectomy. Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1253-8. doi: 10.1007/s00417-007-0556-y. Epub 2007 Mar 7.

    PubMed 17342504

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection and Peribulbar injection in people with Retinal Disease and Diabetic Retinopathy, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: Once 30 minutes after the end of the vitrectomy surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03902925, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.

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