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

Primary Purpose

Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
paracetamol
0,5 % bupivacaine with of 2% lidocaine
1 % ropivacaine with of 2% lidocaine
1 % Ropivacaine
0,5 % bupivacaine
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitreoretinal Surgeries focused on measuring Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA), Peribulbar Block (PBB), bupivacaine, ropivacaine, lidocaine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of SilesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

0,5 % bupivacaine with of 2% lidocaine

0,5 % bupivacaine

1 % ropivacaine with of 2% lidocaine

1 % ropivacaine

paracetamol

Arm Description

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)

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

in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (2,5 ml) with 2% lidocaine (2,5 ml)

in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)

in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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%.
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.
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

Full Information

First Posted
December 27, 2017
Last Updated
August 3, 2020
Sponsor
Medical University of Silesia
Collaborators
Silesian University of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03413371
Brief Title
Different Peribulbar Blocks With SPI-guided Anaesthesia for VRS (P&MSPIVRS)
Acronym
PBBVRS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Silesia
Collaborators
Silesian University of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Crossover Assignment
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0,5 % bupivacaine with of 2% lidocaine
Arm Type
Experimental
Arm Description
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)
Arm Title
0,5 % bupivacaine
Arm Type
Experimental
Arm Description
in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Arm Title
1 % ropivacaine with of 2% lidocaine
Arm Type
Experimental
Arm Description
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
Arm Title
1 % ropivacaine
Arm Type
Experimental
Arm Description
in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
Arm Title
paracetamol
Arm Type
Experimental
Arm Description
in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
0,5 % bupivacaine with of 2% lidocaine
Other Intervention Name(s)
Bupivacaine, Lidocaine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
1 % ropivacaine with of 2% lidocaine
Other Intervention Name(s)
Ropivacaine, Lidocaine
Intervention Description
in group RL patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
Intervention Type
Drug
Intervention Name(s)
1 % Ropivacaine
Other Intervention Name(s)
ropivacaine
Intervention Description
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Intervention Type
Drug
Intervention Name(s)
0,5 % bupivacaine
Other Intervention Name(s)
bupivacaine
Intervention Description
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
Primary Outcome Measure Information:
Title
pain perception intraoperatively
Description
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
Secondary Outcome Measure Information:
Title
oculocardiac reflex rate
Description
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
Title
pain perception postoperatively
Description
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.
Title
PONV (postoperative nausea and vomiting)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Silesia
City
Sosnowiec
State/Province
Silesia
ZIP/Postal Code
41-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michał J. Stasiowski
Phone
696797922
Ext
0048
Email
mstasiowski.anest@gmail.com
First Name & Middle Initial & Last Name & Degree
Lech Krawczyk, Ph. Dr.
Phone
323682341
Ext
0048
Email
lech.kraw@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
article in Anesthesiology and Intensive Therapy in 2021, case reports
Citations:
PubMed Identifier
25032676
Citation
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Results Reference
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PubMed Identifier
23471754
Citation
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.
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PubMed Identifier
24012235
Citation
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24535604
Citation
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25582785
Citation
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.
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Citation
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Citation
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Different Peribulbar Blocks With SPI-guided Anaesthesia for VRS (P&MSPIVRS)

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