SPI-directed Analgesia for Vitreoretinal Surgeries (SPIVS)

January 18, 2018 updated by: Michał Stasiowski, Medical University of Silesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Sosnowiec, Silesia, Poland, 41-200
        • Medical University of Silesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: metamizol
analgesic drug
Drug: Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram
Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Lidocaine
EXPERIMENTAL: acetaminophen
analgesic drug
Drug: Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram
Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Lidocaine
Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Names:
  • Alcaine
EXPERIMENTAL: 0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Lidocaine
Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Names:
  • Alcaine
Drug: Acetaminophen
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
Other Names:
  • paracetamol
EXPERIMENTAL: Proxymetacaine
topical analgesia
Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Names:
  • Alcaine
Drug: Acetaminophen
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
Other Names:
  • paracetamol
PLACEBO_COMPARATOR: control group
patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
Drug: Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram
Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Lidocaine
Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Names:
  • Alcaine
Drug: Acetaminophen
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
Other Names:
  • paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oculocardiac reflex rate
Time Frame: intraoperatively
The investigators will compare the rate of presence of OCR intraoperatively in studied groups
intraoperatively
pain perception intraoperatively
Time Frame: 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
intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain perception postoperatively
Time Frame: up to one hour after discharge to postoperative unit.
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.
up to one hour after discharge to postoperative unit.
PONV
Time Frame: up to one hour
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.
up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Silesian University of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianMUKOAiIT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

article in European Journal of Anaesthesiology in 2018, case reports

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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