Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Retinal Disease; Maculopathy
• Intervention / Treatment: Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection; Procedure: Peribulbar injection

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirao Preto, SP, Brazil, 14049-900
      • School of Medicine - Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1- Sub-tenon plus lidocaine jelly; 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.	Procedure: Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection; 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
ACTIVE_COMPARATOR: Group 2- peribulbar; Patients are going to be submitted to peribulbar injection of 4-6 ml of ropivacaine 10% previous to 23 G pars plana vitrectomy.	Procedure: Peribulbar injection; Peribulbar injection of 4-6 ml of ropivacaine 10%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once 30 minutes after the end of the vitrectomy surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Surgical complications referred by the surgeon during vitrectomy	Once At the end of vitrectomy surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	Duration of vitrectomy in minutes	Once At the end of vitrectomy surgery
Anesthetic medications	Other anesthetic medication for controlling pain administered during the study	Once during the vitrectomy surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Jefferson AS Ribeiro, PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (ACTUAL): April 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: anesthesia; Pain; diabetic retinopathy; vitrectomy; retinal disease; maculopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: ST anesthesia for PPV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No