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SPI-directed Analgesia for Vitreoretinal Surgeries (SPIVS)

Primary Purpose

Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Metamizol

Acetaminophen

0,5 % bupivacaine with of 2% lidocaine

Proxymetacaine

About this trial

This is an interventional diagnostic 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), Topical Analgesia (TA), Oculocardiac reflex (OCR), Postoperative nausea nad vomiting (PONV), paracetamol, metamizol

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 metamizole
necessity of administration of vasoactive drugs influencing SPI monitoring
pregnancy

Sites / Locations

Medical University of Silesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

metamizol

acetaminophen

0,5 % bupivacaine with of 2% lidocaine

Proxymetacaine

control group

Arm Description

analgesic drug

a volume of 5 ml of analgesic solution for regional peribulbar block

topical analgesia

patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.

Outcomes

Primary Outcome Measures

pain perception intraoperatively

The investigators will compare the efficacy of analgesia intraoperatively according to technique of analgesia used preoperatively. 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 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

oculocardiac reflex rate

The investigators will compare the rate of presence of OCR intraoperatively in studied groups

Secondary Outcome Measures

pain perception postoperatively

The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: either local peribulbar block or topical analgesia or intravenous infusion of either metamizol or acetaminophen. The investigators use NRS and compare it with SPI values.

PONV

The investigators will compare the presence of PONV after emergence from GA in studied groups. The investigators will observe patients postoperatively and record any incidence of nausea or vomiting and in the abovementioned case the investigators will administer a standard dose of antiemetic drug.

Full Information

NCT ID

NCT02973581

First Posted

November 22, 2016

Last Updated

January 18, 2018

Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02973581

Brief Title

SPI-directed Analgesia for Vitreoretinal Surgeries

Acronym

SPIVS

Official Title

Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively. Patients received general anaesthesia alone or combined with either preemptive analgesia using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2% lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of acetaminophen in a doseof 10-15mg/kg of body weight.

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 parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.

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

Keywords

Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA), Peribulbar Block (PBB), Topical Analgesia (TA), Oculocardiac reflex (OCR), Postoperative nausea nad vomiting (PONV), paracetamol, metamizol

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metamizol

Arm Type

Experimental

Arm Description

analgesic drug

Arm Title

acetaminophen

Arm Type

Experimental

Arm Description

analgesic drug

Arm Title

0,5 % bupivacaine with of 2% lidocaine

Arm Type

Experimental

Arm Description

a volume of 5 ml of analgesic solution for regional peribulbar block

Arm Title

Proxymetacaine

Arm Type

Experimental

Arm Description

topical analgesia

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.

Intervention Type

Drug

Intervention Name(s)

Metamizol

Intervention Description

in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Other 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)

Lidocaine

Intervention Description

in group PBB 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)

Intervention Type

Drug

Intervention Name(s)

Proxymetacaine

Other Intervention Name(s)

Alcaine

Intervention Description

in group T patients will receive topical analgesia using a solution of 0,5% Alcaine

Primary Outcome Measure Information:

Title

pain perception intraoperatively

Description

Time Frame

intraoperatively

Title

oculocardiac reflex rate

Description

The investigators will compare the rate of presence of OCR intraoperatively in studied groups

Time Frame

intraoperatively

Secondary Outcome Measure Information:

Title

pain perception postoperatively

Description

Time Frame

up to one hour after discharge to postoperative unit.

Title

PONV

Description

Time Frame

up to one hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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 metamizole 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

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

article in European Journal of Anaesthesiology in 2018, case reports

Citations:

PubMed Identifier

10486687

Citation

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.

Results Reference

background

PubMed Identifier

25032676

Citation

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.

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.

Results Reference

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PubMed Identifier

24012235

Citation

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Results Reference

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PubMed Identifier

24535604

Citation

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Results Reference

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PubMed Identifier

25582785

Citation

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Citation

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Citation

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Citation

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SPI-directed Analgesia for Vitreoretinal Surgeries

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