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SPI-directed Analgesia for Vitreoretinal Surgeries (SPIVS)

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ClinicalTrials.gov Identifier: NCT02973581
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Silesian University of Medicine
Information provided by (Responsible Party):
Michał Stasiowski, Medical University of Silesia

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.


Condition or disease Intervention/treatment Phase
Vitreoretinal Surgeries Postoperative Nausea and Vomiting Postoperative Pain Drug: Metamizol Drug: Acetaminophen Drug: 0,5 % bupivacaine with of 2% lidocaine Drug: Proxymetacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Lidocaine

Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Name: Alcaine

Experimental: 0,5 % bupivacaine with of 2% lidocaine
a volume of 5 ml of analgesic solution for regional peribulbar block
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 Name: paracetamol

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 Name: Lidocaine

Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Name: Alcaine

Experimental: Proxymetacaine
topical analgesia
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 Name: paracetamol

Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Name: Alcaine

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: 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 Name: paracetamol

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 Name: Lidocaine

Drug: Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other Name: Alcaine




Primary Outcome Measures :
  1. 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

  2. oculocardiac reflex rate [ Time Frame: intraoperatively ]
    The investigators will compare the rate of presence of OCR intraoperatively in studied groups


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973581


Locations
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Poland
Medical University of Silesia
Sosnowiec, Silesia, Poland, 41-200
Sponsors and Collaborators
Medical University of Silesia
Silesian University of Medicine

Publications of Results:

Other Publications:
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Responsible Party: Michał Stasiowski, Principal Investigator, Department of Anaesthesiology and Intensive Therapy, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT02973581     History of Changes
Other Study ID Numbers: SilesianMUKOAiIT2
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: article in European Journal of Anaesthesiology in 2018, case reports

Keywords provided by Michał Stasiowski, Medical University of Silesia:
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

Additional relevant MeSH terms:
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Pain, Postoperative
Nausea
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics
Bupivacaine
Lidocaine
Proxymetacaine
Acetaminophen
Dipyrone
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal