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

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

Sponsors

Lead Sponsor: Medical University of Silesia

Collaborator: Silesian University of Medicine

Source 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.

Overall Status Recruiting
Start Date April 26, 2018
Completion Date February 1, 2020
Primary Completion Date February 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
pain perception intraoperatively intraoperative assessment
Secondary Outcome
Measure Time Frame
oculocardiac reflex rate intraoperative assessment
pain perception postoperatively up to one hour after discharge to postoperative unit performed every 10 minutes.
PONV (postoperative nausea and vomiting) postoperative assessment up to 24 hours
Enrollment 175
Condition
Intervention

Intervention Type: Drug

Intervention Name: paracetamol

Description: 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

Intervention Type: Drug

Intervention Name: 0,5 % bupivacaine with of 2% lidocaine

Description: 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)

Intervention Type: Drug

Intervention Name: 1 % ropivacaine with of 2% lidocaine

Description: 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)

Intervention Type: Drug

Intervention Name: 1 % Ropivacaine

Description: in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)

Other Name: ropivacaine

Intervention Type: Drug

Intervention Name: 0,5 % bupivacaine

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

Other Name: bupivacaine

Eligibility

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 paracetamol necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy

Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Location
Facility: Status: Contact: Contact Backup: Medical University of Silesia Michał J. Stasiowski 696797922 0048 [email protected]
Location Countries

Poland

Verification Date

March 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

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

Type: Experimental

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)

Label: 0,5 % bupivacaine

Type: Experimental

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

Label: 1 % ropivacaine with of 2% lidocaine

Type: Experimental

Description: 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)

Label: 1 % ropivacaine

Type: Experimental

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

Label: paracetamol

Type: Experimental

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

Acronym PBBVRS
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Crossover Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Masking Description: Single (Participant)

Source: ClinicalTrials.gov