SPI-directed Analgesia for Vitreoretinal Surgeries (SPIVS)

Medical University of Silesia

Status: Completed

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

Treatments: Drug: Acetaminophen; Drug: Metamizol; Drug: 0,5 % bupivacaine with of 2% lidocaine; Drug: Proxymetacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02973581

SilesianMUKOAiIT2

Details and patient eligibility

About

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.

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 parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.

Enrollment: 176 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 metamizole
• necessity of administration of vasoactive drugs influencing SPI monitoring
• pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 5 patient groups, including a placebo group

metamizol

Experimental group

Description:

analgesic drug

Treatment:

Drug: Metamizol

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

acetaminophen

Experimental group

Description:

analgesic drug

Treatment:

Drug: Proxymetacaine

Drug: Metamizol

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

0,5 % bupivacaine with of 2% lidocaine

Experimental group

Description:

a volume of 5 ml of analgesic solution for regional peribulbar block

Treatment:

Drug: Proxymetacaine

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

Drug: Acetaminophen

Proxymetacaine

Experimental group

Description:

topical analgesia

Treatment:

Drug: Proxymetacaine

Drug: Acetaminophen

control group

Placebo Comparator group

Description:

patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.

Treatment:

Drug: Proxymetacaine

Drug: Metamizol

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

Drug: Acetaminophen