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

Medical University of Silesia

Status: Completed

Conditions: Postoperative Pain; Oculocardiac Reflex; Postoperative Nausea and Vomiting; Vitreoretinal Surgeries

Treatments: Drug: paracetamol; Drug: 0,5 % bupivacaine; Drug: 1 % Ropivacaine; Drug: 0,5 % bupivacaine with of 2% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03413371

SilesianMUKOAiIT8

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 4 patient groups

0,5 % bupivacaine with of 2% lidocaine

Experimental group

Description:

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)

Treatment:

Drug: 1 % Ropivacaine

Drug: 0,5 % bupivacaine

Drug: paracetamol

0,5 % bupivacaine

Experimental group

Description:

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

Treatment:

Drug: 0,5 % bupivacaine with of 2% lidocaine

Drug: 1 % Ropivacaine

Drug: paracetamol

1 % ropivacaine

Experimental group

Description:

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

Treatment:

Drug: 0,5 % bupivacaine with of 2% lidocaine

Drug: 0,5 % bupivacaine

Drug: paracetamol

paracetamol

Experimental group

Description:

in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia

Treatment:

Drug: 0,5 % bupivacaine with of 2% lidocaine

Drug: 1 % Ropivacaine

Drug: 0,5 % bupivacaine