SPI-directed Analgesia for Vitreoretinal Surgeries

Not Applicable

Completed

• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Vitreoretinal Surgeries
• Interventions: Drug: Metamizol; Drug: Acetaminophen; Drug: 0,5 % bupivacaine with of 2% lidocaine; Drug: Proxymetacaine

• Registration Number: NCT02973581
• Lead Sponsor: Medical University of Silesia

Brief Summary

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.

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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-25
• Primary Completion: 2017-02
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metamizol	0,5 % bupivacaine with of 2% lidocaine	analgesic drug
control group	0,5 % bupivacaine with of 2% lidocaine	patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
0,5 % bupivacaine with of 2% lidocaine	0,5 % bupivacaine with of 2% lidocaine	a volume of 5 ml of analgesic solution for regional peribulbar block
acetaminophen	0,5 % bupivacaine with of 2% lidocaine	analgesic drug
metamizol	Metamizol	analgesic drug
acetaminophen	Metamizol	analgesic drug
acetaminophen	Proxymetacaine	analgesic drug
0,5 % bupivacaine with of 2% lidocaine	Acetaminophen	a volume of 5 ml of analgesic solution for regional peribulbar block
Proxymetacaine	Acetaminophen	topical analgesia
0,5 % bupivacaine with of 2% lidocaine	Proxymetacaine	a volume of 5 ml of analgesic solution for regional peribulbar block
control group	Acetaminophen	patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
Proxymetacaine	Proxymetacaine	topical analgesia
control group	Metamizol	patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.
control group	Proxymetacaine	patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.

Primary Outcome Measures

Name	Time	Method
pain perception intraoperatively	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
oculocardiac reflex rate	intraoperatively	The investigators will compare the rate of presence of OCR intraoperatively in studied groups

Secondary Outcome Measures

Name	Time	Method
pain perception postoperatively	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.
PONV	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.

Trial Locations

Locations (1)

Medical University of Silesia; 🇵🇱 Sosnowiec, Silesia, Poland