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

Postoperative Pain Clinical Trial

— PBBVRS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413371
• Other study ID #: SilesianMUKOAiIT8
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2020
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Oculocardiac Reflex
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vitreoretinal Surgeries
• Vomiting

Intervention

Drug:
• paracetamol
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
• 0,5 % bupivacaine with of 2% lidocaine
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)
• 1 % ropivacaine with of 2% lidocaine
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)
• 1 % Ropivacaine
in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
• 0,5 % bupivacaine
in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Sosnowiec	Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Silesian University of Medicine

Country where clinical trial is conducted

Poland, 

References & Publications (13)

Calenda E, Olle P, Muraine M, Brasseur G. Peribulbar anesthesia and sub-Tenon injection for vitreoretinal surgery: 300 cases. Acta Ophthalmol Scand. 2000 Apr;78(2):196-9. — View Citation

Calenda E, Quintyn JC, Brasseur G. Peribulbar anaesthesia using a combination of lidocaine, bupivocaine and clonidine in vitreoretinal surgery. Indian J Ophthalmol. 2002 Sep;50(3):205-8. — View Citation

Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. — View Citation

Ghali AM. The efficacy of 0.75% levobupivacaine versus 0.75% ropivacaine for peribulbar anesthesia in vitreoretinal surgery. Saudi J Anaesth. 2012 Jan;6(1):22-6. doi: 10.4103/1658-354X.93050. — View Citation

Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 — View Citation

Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Höcker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. — View Citation

Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007. Review. — View Citation

Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10 — View Citation

Jaichandran VV, Raman R, Gella L, Sharma T. Local anesthetic agents for vitreoretinal surgery: no advantage to mixing solutions. Ophthalmology. 2015 May;122(5):1030-3. doi: 10.1016/j.ophtha.2014.11.026. Epub 2015 Jan 10. — View Citation

Mandelcorn M, Taback N, Mandelcorn E, Ananthanarayan C. Risk factors for pain and nausea following retinal and vitreous surgery under conscious sedation. Can J Ophthalmol. 1999 Aug;34(5):281-5. — View Citation

Sajedi P, Nejad MS, Montazeri K, Baloochestani E. Comparing the preventive effect of 2 percent topical lidocaine and intravenous atropine on oculocardiac reflex in ophthalmological surgeries under general anesthesia. Int J Prev Med. 2013 Nov;4(11):1258-65 — View Citation

Seidenari P, Santin G, Milani P, David A. Peribulbar and retrobulbar combined anesthesia for vitreoretinal surgery using ropivacaine. Eur J Ophthalmol. 2006 Mar-Apr;16(2):295-9. — View Citation

Subramaniam R, Subbarayudu S, Rewari V, Singh RP, Madan R. Usefulness of pre-emptive peribulbar block in pediatric vitreoretinal surgery: a prospective study. Reg Anesth Pain Med. 2003 Jan-Feb;28(1):43-7. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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