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

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ClinicalTrials.gov Identifier: NCT03413371
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Silesian University of Medicine
Information provided by (Responsible Party):
Medical University of Silesia

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


Condition or disease Intervention/treatment Phase
Vitreoretinal Surgeries Postoperative Nausea and Vomiting Postoperative Pain Oculocardiac Reflex Drug: paracetamol Drug: 0,5 % bupivacaine with of 2% lidocaine Drug: 1 % ropivacaine with of 2% lidocaine Drug: 1 % Ropivacaine Drug: 0,5 % bupivacaine 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Crossover Assignment
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: 0,5 % bupivacaine with of 2% lidocaine
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
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

Drug: 1 % ropivacaine with of 2% lidocaine
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)
Other Names:
  • Ropivacaine
  • Lidocaine

Drug: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Name: ropivacaine

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

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

Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Bupivacaine
  • Lidocaine

Drug: 1 % ropivacaine with of 2% lidocaine
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)
Other Names:
  • Ropivacaine
  • Lidocaine

Drug: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Name: ropivacaine

Experimental: 1 % ropivacaine with of 2% lidocaine
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)
Drug: paracetamol
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

Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Bupivacaine
  • Lidocaine

Drug: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Name: ropivacaine

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

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

Drug: 0,5 % bupivacaine with of 2% lidocaine
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)
Other Names:
  • Bupivacaine
  • Lidocaine

Drug: 1 % ropivacaine with of 2% lidocaine
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)
Other Names:
  • Ropivacaine
  • Lidocaine

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

Experimental: paracetamol
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
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)
Other Names:
  • Bupivacaine
  • Lidocaine

Drug: 1 % ropivacaine with of 2% lidocaine
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)
Other Names:
  • Ropivacaine
  • Lidocaine

Drug: 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
Other Name: ropivacaine

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




Primary Outcome Measures :
  1. pain perception intraoperatively [ Time Frame: intraoperative assessment ]
    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 :
  1. oculocardiac reflex rate [ Time Frame: intraoperative assessment ]
    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%.

  2. pain perception postoperatively [ Time Frame: up to one hour after discharge to postoperative unit performed every 10 minutes. ]
    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.

  3. PONV (postoperative nausea and vomiting) [ Time Frame: postoperative assessment up to 24 hours ]
    The investigators will compare the presence of every incident of PONV after emergence from GA in studied groups and use predictive Apfel Score



Information from the National Library of Medicine

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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 paracetamol 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): NCT03413371


Locations
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Poland
Medical University of Silesia Recruiting
Sosnowiec, Silesia, Poland, 41-200
Contact: Michał J. Stasiowski    696797922 ext 0048    mstasiowski.anest@gmail.com   
Contact: Lech Krawczyk, Ph. Dr.    323682341 ext 0048    lech.kraw@gmail.com   
Sponsors and Collaborators
Medical University of Silesia
Silesian University of Medicine

Publications of Results:

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Responsible Party: Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03413371     History of Changes
Other Study ID Numbers: SilesianMUKOAiIT8
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Informed Consent Form (ICF)
Time Frame: article in Anesthesiology and Intensive Therapy in 2021, case reports

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

Keywords provided by Medical University of Silesia:
Surgical Pleth Index (SPI)
General Anaesthesia (GA),
Numerical Rating Scale (NRS)
Adequacy of Anaesthesia (AoA)
Peribulbar Block (PBB)
bupivacaine
ropivacaine
lidocaine

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Pharmaceutical Solutions
Anesthetics
Bupivacaine
Lidocaine
Ropivacaine
Acetaminophen
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