Pain During Pars Plana Vitrectomy With Sub-tenon Anesthesia

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902925
• Other study ID #: ST anesthesia for PPV
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Maculopathy
• Retinal Disease
• Retinal Diseases

Intervention

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
• Peribulbar injection
Peribulbar injection of 4-6 ml of ropivacaine 10%

Locations

Country	Name	City	State
Brazil	School of Medicine - Clinical Hospital	Ribeirao Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View 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. — View 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. — View Citation

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

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

Stevens JD, Foss AJ, Hamilton AM. No-needle one-quadrant sub-tenon anaesthesia for panretinal photocoagulation. Eye (Lond). 1993;7 ( Pt 6):768-71. — View 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. — View 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. Epub 2007 Mar 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of surgery	Duration of vitrectomy in minutes	Once At the end of vitrectomy surgery
Other	Anesthetic medications	Other anesthetic medication for controlling pain administered during the study	Once during the vitrectomy surgery
Primary	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	Surgical complications	Surgical complications referred by the surgeon during vitrectomy	Once At the end of vitrectomy surgery