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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain, Oculocardiac Reflex

Intervention / Treatment
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* Drug: paracetamol
* Drug: 0,5 % bupivacaine with of 2% lidocaine
* Drug: 1 % ropivacaine with of 2% lidocaine
* Drug: 1 % Ropivacaine
* Drug: 0,5 % bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0,5 % bupivacaine with of 2% lidocaine<br>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<br>* 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<br>Drug: 1 % ropivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % Ropivacaine<br>* in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)<br>* Other names: ropivacaine;Drug: 0,5 % bupivacaine<br>* in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)<br>* Other names: bupivacaine;|
| Experimental: 0,5 % bupivacaine<br>in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml) | Drug: paracetamol<br>* 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<br>Drug: 0,5 % bupivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % ropivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % Ropivacaine<br>* in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)<br>* Other names: ropivacaine;|
| Experimental: 1 % ropivacaine with of 2% lidocaine<br>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<br>* 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<br>Drug: 0,5 % bupivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % Ropivacaine<br>* in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)<br>* Other names: ropivacaine;Drug: 0,5 % bupivacaine<br>* in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)<br>* Other names: bupivacaine;|
| Experimental: 1 % ropivacaine<br>in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml) | Drug: paracetamol<br>* 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<br>Drug: 0,5 % bupivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % ropivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 0,5 % bupivacaine<br>* in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)<br>* Other names: bupivacaine;|
| Experimental: paracetamol<br>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<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % ropivacaine with of 2% lidocaine<br>* 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)<br>* Other names: Lidocaine;Drug: 1 % Ropivacaine<br>* in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)<br>* Other names: ropivacaine;Drug: 0,5 % bupivacaine<br>* in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain perception intraoperatively | 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 | intraoperative assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oculocardiac reflex rate | 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%. | intraoperative assessment | 
| pain perception postoperatively | 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. | up to one hour after discharge to postoperative unit performed every 10 minutes. | 
| PONV (postoperative nausea and vomiting) | The investigators will compare the presence of every incident of PONV after emergence from GA in studied groups and use predictive Apfel Score | postoperative assessment up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Pleth Index (SPI), General Anaesthesia (GA),, Numerical Rating Scale (NRS), Adequacy of Anaesthesia (AoA), Peribulbar Block (PBB), bupivacaine, ropivacaine, lidocaine