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NCT Number: NCT02973581

SPI-directed Analgesia for Vitreoretinal Surgeries

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.

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Key information

Conditions

Vitreoretinal Surgeries Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metamizol

Drug

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

Acetaminophen

Drug

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

0,5 % bupivacaine with of 2% lidocaine

Drug

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

Proxymetacaine

Drug

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

Other names: Alcaine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Silesian University of Medicine

Registry information

Official study 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

Acronym: SPIVS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2016
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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