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Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Primary Purpose

Retinal Disease, Diabetic Retinopathy, Maculopathy

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection

Peribulbar injection

About this trial

This is an interventional treatment trial for Retinal Disease focused on measuring vitrectomy, anesthesia, retinal disease, Pain, diabetic retinopathy, maculopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

School of Medicine - Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1- Sub-tenon plus lidocaine jelly

Group 2- peribulbar

Arm Description

Patients 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.

Patients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical complications

Surgical complications referred by the surgeon during vitrectomy

Full Information

NCT ID

NCT03902925

First Posted

April 2, 2019

Last Updated

October 31, 2019

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03902925

Brief Title

Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Disease, Diabetic Retinopathy, Maculopathy

Keywords

vitrectomy, anesthesia, retinal disease, Pain, diabetic retinopathy, maculopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1- Sub-tenon plus lidocaine jelly

Arm Type

Experimental

Arm Description

Patients 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.

Arm Title

Group 2- peribulbar

Arm Type

Active Comparator

Arm Description

Patients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.

Intervention Type

Procedure

Intervention Name(s)

Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Peribulbar injection

Intervention Description

Peribulbar injection of 4-6 ml of ropivacaine 10%

Primary Outcome Measure Information:

Title

Pain score

Description

Time Frame

Once 30 minutes after the end of the vitrectomy surgery

Secondary Outcome Measure Information:

Title

Surgical complications

Description

Surgical complications referred by the surgeon during vitrectomy

Time Frame

Once At the end of vitrectomy surgery

Other Pre-specified Outcome Measures:

Title

Duration of surgery

Description

Duration of vitrectomy in minutes

Time Frame

Once At the end of vitrectomy surgery

Title

Anesthetic medications

Description

Other anesthetic medication for controlling pain administered during the study

Time Frame

Once during the vitrectomy surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jefferson AS Ribeiro, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Medicine - Clinical Hospital

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14049-900

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We intend to have patient data stored but not individually available for researches at other sites in order to preserve anonymity of the patient.

Citations:

PubMed Identifier

17183205

Citation

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.

Results Reference

background

PubMed Identifier

8119430

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

9349156

Citation

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.

Results Reference

background

PubMed Identifier

1015603

Citation

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.

Results Reference

background

PubMed Identifier

9775241

Citation

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.

Results Reference

background

PubMed Identifier

17342504

Citation

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.

Results Reference

result

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Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

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