CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
paracetamol +3 moredrug
Likely dose
paracetamol 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03413371
NCT03413371N/ACompleted

Influence of SPI-guided Analgesia With Preventive Different Peribulbar Blocks (PBB) on the Presence of OCR, Postoperative Pain, PONV in Patients Undergoing VRS Under General Anaesthesia: a Randomised, Controlled Trial

Medical University of Silesia·interventional·Posted Jan 29, 2018·Updated May 28, 2026

In Brief

A clinical study evaluating paracetamol, 0,5 % bupivacaine with of 2% lidocaine, and 2 other interventions for Vitreoretinal Surgeries and 3 related conditions. Completed, enrolled 184 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 29, 2018
Enrollment StartApr 26, 2018
Primary CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 8.4 years ago

Interventions

paracetamoldrug

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

0,5 % bupivacaine with of 2% lidocainedrug

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)

1 % Ropivacainedrug

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

0,5 % bupivacainedrug

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