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

Not Applicable

• Conditions: Oculocardiac Reflex; Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain
• Interventions: Drug: paracetamol; Drug: 0,5 % bupivacaine with of 2% lidocaine; Drug: 1 % ropivacaine with of 2% lidocaine; Drug: 1 % Ropivacaine; Drug: 0,5 % bupivacaine

• Registration Number: NCT03413371
• Lead Sponsor: Medical University of Silesia

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.

Study Timeline

• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-29
• Study Start: 2018-04-26
• Status Verified: 2020-06
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0,5 % bupivacaine with of 2% lidocaine	0,5 % bupivacaine	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)
1 % ropivacaine with of 2% lidocaine	0,5 % bupivacaine	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)
1 % ropivacaine	0,5 % bupivacaine with of 2% lidocaine	in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
paracetamol	0,5 % bupivacaine with of 2% lidocaine	in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
paracetamol	0,5 % bupivacaine	in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
0,5 % bupivacaine with of 2% lidocaine	1 % Ropivacaine	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)
0,5 % bupivacaine	1 % Ropivacaine	in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
0,5 % bupivacaine with of 2% lidocaine	1 % ropivacaine with of 2% lidocaine	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)
0,5 % bupivacaine	1 % ropivacaine with of 2% lidocaine	in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
1 % ropivacaine	0,5 % bupivacaine	in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
paracetamol	1 % ropivacaine with of 2% lidocaine	in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
paracetamol	1 % Ropivacaine	in P group patients will receive preemptive analgesia using 1 gram of paracetamol before induction of general anaesthesia
0,5 % bupivacaine	0,5 % bupivacaine with of 2% lidocaine	in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
1 % ropivacaine with of 2% lidocaine	0,5 % bupivacaine with of 2% lidocaine	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)
1 % ropivacaine with of 2% lidocaine	1 % Ropivacaine	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)
1 % ropivacaine	1 % ropivacaine with of 2% lidocaine	in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)
0,5 % bupivacaine with of 2% lidocaine	paracetamol	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)
0,5 % bupivacaine	paracetamol	in group B patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
1 % ropivacaine with of 2% lidocaine	paracetamol	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)
1 % ropivacaine	paracetamol	in group RL patients in group BF will receive regional peribulbar block using a solution of 1% ropivacaine (5 ml)

Primary Outcome Measures

Name	Time	Method
pain perception intraoperatively	intraoperative assessment	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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