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NCT Number: NCT03413371

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

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

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Key information

Conditions

Vitreoretinal Surgeries Nausea Neurologic Manifestations Oculocardiac Reflex Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Paracetamol

Drug

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% lidocaine

Drug

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: Bupivacaine, Lidocaine

1 % Ropivacaine

Drug

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

Other names: ropivacaine

0,5 % bupivacaine

Drug

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

Other names: bupivacaine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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%.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Silesian University of Medicine

Registry information

Official study title

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

Acronym: PBBVRS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2018
Registry last updated
May 28, 2026

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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