Clinical trial NCT03413371: Different Peribulbar Blocks With SPI-guided Anaesthesia for VRS (P&MSPIVRS)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitreoretinal Surgeries
Postoperative Nausea and Vomiting
Postoperative Pain
Oculocardiac Reflex
Keywords: Surgical Pleth Index (SPI)
General Anaesthesia (GA),
Numerical Rating Scale (NRS)
Adequacy of Anaesthesia (AoA)
Peribulbar Block (PBB)
bupivacaine
ropivacaine
lidocaine
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Silesian University of Medicine
First posted: 2018-01-29
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Crossover Assignment
Primary purpose: PREVENTION

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

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.

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 paracetamol necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy

Primary outcomes:
measure: pain perception intraoperatively
timeFrame: intraoperative assessment
Secondary outcomes:
measure: oculocardiac reflex rate
timeFrame: intraoperative assessment
measure: pain perception postoperatively
timeFrame: up to one hour after discharge to postoperative unit performed every 10 minutes.
measure: PONV (postoperative nausea and vomiting)
timeFrame: postoperative assessment up to 24 hours
Other outcomes:
Locations:
city: Sosnowiec
country: Poland
facility: Medical University of Silesia
state: Silesia
Study officials:
References:
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