Different Peribulbar Blocks With SPI-guided Anaesthesia for VRS (P&MSPIVRS)
NCT ID: NCT03413371
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
184 participants
INTERVENTIONAL
2018-04-26
2022-12-20
Brief Summary
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Patients will receive general anaesthesia combined with either preventive PBB using either lidocaine with bupivacaine or bupivacaine or ropivacaine
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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)
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
1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
0,5 % bupivacaine
in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
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
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)
1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
1 % ropivacaine
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
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
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)
0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
paracetamol
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
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)
1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Interventions
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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
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)
1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Silesian University of Medicine
OTHER
Medical University of Silesia
OTHER
Responsible Party
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Locations
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Medical University of Silesia
Sosnowiec, Silesian Voivodeship, Poland
Countries
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References
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Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
Jaichandran VV, Raman R, Gella L, Sharma T. Local anesthetic agents for vitreoretinal surgery: no advantage to mixing solutions. Ophthalmology. 2015 May;122(5):1030-3. doi: 10.1016/j.ophtha.2014.11.026. Epub 2015 Jan 10.
Ghali AM. The efficacy of 0.75% levobupivacaine versus 0.75% ropivacaine for peribulbar anesthesia in vitreoretinal surgery. Saudi J Anaesth. 2012 Jan;6(1):22-6. doi: 10.4103/1658-354X.93050.
Seidenari P, Santin G, Milani P, David A. Peribulbar and retrobulbar combined anesthesia for vitreoretinal surgery using ropivacaine. Eur J Ophthalmol. 2006 Mar-Apr;16(2):295-9. doi: 10.1177/112067210601600216.
Subramaniam R, Subbarayudu S, Rewari V, Singh RP, Madan R. Usefulness of pre-emptive peribulbar block in pediatric vitreoretinal surgery: a prospective study. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):43-7. doi: 10.1053/rapm.2003.50032.
Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010.
Calenda E, Olle P, Muraine M, Brasseur G. Peribulbar anesthesia and sub-Tenon injection for vitreoretinal surgery: 300 cases. Acta Ophthalmol Scand. 2000 Apr;78(2):196-9. doi: 10.1034/j.1600-0420.2000.078002196.x.
Sajedi P, Nejad MS, Montazeri K, Baloochestani E. Comparing the preventive effect of 2 percent topical lidocaine and intravenous atropine on oculocardiac reflex in ophthalmological surgeries under general anesthesia. Int J Prev Med. 2013 Nov;4(11):1258-65.
Calenda E, Quintyn JC, Brasseur G. Peribulbar anaesthesia using a combination of lidocaine, bupivocaine and clonidine in vitreoretinal surgery. Indian J Ophthalmol. 2002 Sep;50(3):205-8.
Mandelcorn M, Taback N, Mandelcorn E, Ananthanarayan C. Risk factors for pain and nausea following retinal and vitreous surgery under conscious sedation. Can J Ophthalmol. 1999 Aug;34(5):281-5.
Other Identifiers
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SilesianMUKOAiIT8
Identifier Type: -
Identifier Source: org_study_id
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