An interventional study of paracetamol and 0,5 % bupivacaine with of 2% lidocaine in Vitreoretinal Surgeries, Postoperative Nausea and Vomiting and Postoperative Pain, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Prevention
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.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's enrollment of 184 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Drug: 1 % Ropivacaine · Drug: 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 · Drug: 0,5 % bupivacaine with of 2% lidocaine · Drug: 1 % Ropivacaine
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
Drug: paracetamol · Drug: 0,5 % bupivacaine with of 2% lidocaine · Drug: 0,5 % bupivacaine
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
Drug: 0,5 % bupivacaine with of 2% lidocaine · Drug: 1 % Ropivacaine · Drug: 0,5 % bupivacaine
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 page: Bupivacaine
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)
Also known as: Bupivacaine, Lidocaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Also known as: ropivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Also known as: bupivacaine
pain perception intraoperatively
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
Time frame: intraoperative assessment
oculocardiac reflex rate
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%.
Time frame: intraoperative assessment
pain perception postoperatively
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.
Time frame: up to one hour after discharge to postoperative unit performed every 10 minutes.
PONV (postoperative nausea and vomiting)
The investigators will compare the presence of every incident of PONV after emergence from GA in studied groups and use predictive Apfel Score
Time frame: postoperative assessment up to 24 hours
Plan to share: Yes
Supporting information: Informed consent form
Time frame: article in Anesthesiology and Intensive Therapy in 2021, case reports
Ran from Apr 2018 to primary completion in Dec 2022, 55 months.
Of 181 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 55 months is above that.
Counting every sponsor, half of 181 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Acetaminophen · Bupivacaine · Ropivacaine
Postoperative Nausea and Vomiting →
Medical University of Silesia →