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

NCT03413371 | Completed

• 1 other identifier: SilesianMUKOAiIT8
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain; Oculocardiac Reflex

Keywords

Surgical Pleth Index (SPI); General Anaesthesia (GA),; Numerical Rating Scale (NRS); Adequacy of Anaesthesia (AoA); Peribulbar Block (PBB); bupivacaine; ropivacaine; lidocaine

Outcome Measures

Primary Outcomes (1)

• 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

  intraoperative assessment

Secondary Outcomes (3)

• oculocardiac reflex rate

  intraoperative assessment

• pain perception postoperatively

  up to one hour after discharge to postoperative unit performed every 10 minutes.

• PONV (postoperative nausea and vomiting)

  postoperative assessment up to 24 hours

Study Arms (4)

0,5 % bupivacaine with of 2% lidocaine

EXPERIMENTAL

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

0,5 % bupivacaine

EXPERIMENTAL

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

1 % ropivacaine

EXPERIMENTAL

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

paracetamol

EXPERIMENTAL

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

Interventions

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; 0,5 % bupivacaine with of 2% lidocaine; 1 % ropivacaine

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)

Also known as: Bupivacaine, Lidocaine

0,5 % bupivacaine; 1 % ropivacaine; paracetamol

1 % Ropivacaine DRUG

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

Also known as: ropivacaine

0,5 % bupivacaine; 0,5 % bupivacaine with of 2% lidocaine; paracetamol

0,5 % bupivacaine DRUG

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

Also known as: bupivacaine

0,5 % bupivacaine with of 2% lidocaine; 1 % ropivacaine; paracetamol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Silesia: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (13)

• 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.

  PMID: 25032676 RESULT

• 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.

  PMID: 23471754 RESULT

• 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.

  PMID: 24012235 RESULT

• 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.

  PMID: 24535604 RESULT

• 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.

  PMID: 25582785 RESULT

• 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.

  PMID: 22412772 RESULT

• 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.

  PMID: 16703549 RESULT

• 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.

  PMID: 12567343 RESULT

• 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.

  PMID: 11756886 RESULT

• 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.

  PMID: 10794256 RESULT

• 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.

  PMID: 24404359 RESULT

• 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.

  PMID: 12355695 RESULT

• 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.

  PMID: 10486687 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Acetaminophen; Lidocaine; Bupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single (Participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 29, 2018
• Study Start: April 26, 2018
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: September 23, 2025

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: article in Anesthesiology and Intensive Therapy in 2021, case reports

Locations

PL (1)