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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
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.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Medical University of Silesia
Sosnowiec, Silesian Voivodeship, Poland
Start Date
April 26, 2018
Primary Completion Date
December 20, 2022
Completion Date
December 20, 2022
Last Updated
September 23, 2025
184
ACTUAL participants
paracetamol
DRUG
0,5 % bupivacaine with of 2% lidocaine
DRUG
1 % Ropivacaine
DRUG
0,5 % bupivacaine
DRUG
Lead Sponsor
Medical University of Silesia
Collaborators
NCT06862609
NCT07327463
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07436806