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

May 25, 2026 updated by: Medical University of Silesia

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.

Different options of local anesthetic mixtures used for peribulbar block result in different analgetic potency. PBB is supposed to reduce requirement for intraoperative narcotic analgesics when used together with general anaesthesia and therefore may reduce the rate of PONV, OCR and perception of postoperative pain.

The aim of the study is to investigate the influence of different PBBs on abovementioned outcomes.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesian Voivodeship
      • Sosnowiec, Silesian Voivodeship, Poland, 41-200
        • Medical University of Silesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • written consent to participate in the study written consent to undergo general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery

Exclusion Criteria:

  • history of allergy to local anaesthetics or paracetamol necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0,5 % bupivacaine with of 2% lidocaine
in group BL patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
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: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Names:
  • ropivacaine
Drug: 0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Other Names:
  • bupivacaine
Experimental: 0,5 % bupivacaine
in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
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: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Names:
  • ropivacaine
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)
Other Names:
  • Lidocaine
  • Bupivacaine
Experimental: 1 % ropivacaine
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
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
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Other Names:
  • bupivacaine
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)
Other Names:
  • Lidocaine
  • Bupivacaine
Experimental: paracetamol
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
Drug: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Names:
  • ropivacaine
Drug: 0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Other Names:
  • bupivacaine
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)
Other Names:
  • Lidocaine
  • Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain perception intraoperatively
Time Frame: intraoperative assessment
The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively: either peribulbar block or intravenous infusion. The investigators will administer a rescue dose of fentanyl intravenously in a dose of 1 mcg per kg of body weight in the case when SPI (surgical pleh index value) value increases over 15 points in SPI scale every 5 minutes until SPI value decreases back to baseline value. Additionally, the investigators will analyse rescue fentanyl consumption in abovementioned groups
intraoperative assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oculocardiac reflex rate
Time Frame: intraoperative assessment
the investigators will compare the rate of presence of OCR intraoperatively in studied groups observing the presence of heart rate (HR) rapid decrease by 30%.
intraoperative assessment
pain perception postoperatively
Time Frame: up to one hour after discharge to postoperative unit performed every 10 minutes.
The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: sort of anaesthetic mixture used for peribulbar block. The investigators will use the numeric rating scale (NRS) and compare it with surgical pleth index value (SPI) for certain pain perception: mild, moderate, acute.
up to one hour after discharge to postoperative unit performed every 10 minutes.
PONV (postoperative nausea and vomiting)
Time Frame: postoperative assessment up to 24 hours
The investigators will compare the presence of every incident of PONV after emergence from GA in studied groups and use predictive Apfel Score
postoperative assessment up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2018

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianMUKOAiIT8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

article in Anesthesiology and Intensive Therapy in 2021, case reports

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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