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NCT Number: NCT03902925

Pain During Pars Plana Vitrectomy With Sub-tenon 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.

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Key information

Conditions

Retinal Disease Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Maculopathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

School of Medicine - Clinical Hospital

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Peribulbar injection

Procedure

Peribulbar injection of 4-6 ml of ropivacaine 10%

Primary outcomes

  1. Pain score

    Time frame: Once 30 minutes after the end of the vitrectomy surgery

    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 outcomes

  1. Surgical complications

    Time frame: Once At the end of vitrectomy surgery

    Surgical complications referred by the surgeon during vitrectomy

Other outcomes

  1. Duration of surgery

    Time frame: Once At the end of vitrectomy surgery

    Duration of vitrectomy in minutes

  2. Anesthetic medications

    Time frame: Once during the vitrectomy surgery

    Other anesthetic medication for controlling pain administered during the study

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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