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Different Peribulbar Blocks With SPI-guided Anaesthesia for VRS (P&MSPIVRS)

NCT03413371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-09-23

No results posted yet for this study

Summary

The aim of this randomized trial is to assess the efficacy of preventive analgesia using different peribulbar blocks (PBB) under SPI-guided anaesthesia for vitreoretinal surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.

Patients will receive general anaesthesia combined with either preventive PBB using either lidocaine with bupivacaine or bupivacaine or ropivacaine

Conditions

  • Vitreoretinal Surgeries
  • Postoperative Nausea and Vomiting
  • Postoperative Pain
  • Oculocardiac Reflex

Interventions

DRUG

paracetamol

in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight

DRUG

0,5 % bupivacaine with of 2% lidocaine

in group BL patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)

DRUG

1 % Ropivacaine

in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)

DRUG

0,5 % bupivacaine

in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)

Sponsors & Collaborators

  • Silesian University of Medicine

    collaborator OTHER

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2022-12-20
Completion
2022-12-20

Countries

  • Poland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03413371 on ClinicalTrials.gov