Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

NCT03902925 | Completed Phase 1 DMC

• 1 other identifier: ST anesthesia for PPV
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Disease; Diabetic Retinopathy; Maculopathy

Keywords

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

Outcome Measures

Primary Outcomes (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.

  Once 30 minutes after the end of the vitrectomy surgery

Secondary Outcomes (1)

• Surgical complications

  Once At the end of vitrectomy surgery

Other Outcomes (2)

• Duration of surgery

  Once At the end of vitrectomy surgery

• Anesthetic medications

  Once during the vitrectomy surgery

Study Arms (2)

Group 1- Sub-tenon plus lidocaine jelly

EXPERIMENTAL

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

Group 2- peribulbar

ACTIVE COMPARATOR

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

Interventions

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

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

Group 1- Sub-tenon plus lidocaine jelly

Peribulbar injection PROCEDURE

Peribulbar injection of 4-6 ml of ropivacaine 10%

Group 2- peribulbar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Medicine - Clinical Hospital

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (8)

• 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.

  PMID: 17183205 BACKGROUND

• 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.

  PMID: 8119430 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 9349156 BACKGROUND

• 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.

  PMID: 1015603 BACKGROUND

• 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.

  PMID: 9775241 BACKGROUND

• 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.

  PMID: 17342504 RESULT

MeSH Terms

Conditions

Retinal Diseases; Diabetic Retinopathy; Macular Degeneration; Pain

Interventions

Lidocaine; Gels; Injections

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jefferson AS Ribeiro, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: January 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)