SPI-directed Analgesia for Vitreoretinal Surgeries

NCT02973581 | Completed DMC

• 1 other identifier: SilesianMUKOAiIT2
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain

Keywords

Surgical Pleth Index (SPI); General Anaesthesia (GA),; Numerical Rating Scale (NRS); Adequacy of Anaesthesia (AoA); Peribulbar Block (PBB); Topical Analgesia (TA); Oculocardiac reflex (OCR); Postoperative nausea nad vomiting (PONV); paracetamol; metamizol

Outcome Measures

Primary Outcomes (2)

• pain perception 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

  intraoperatively

• oculocardiac reflex rate

  The investigators will compare the rate of presence of OCR intraoperatively in studied groups

  intraoperatively

Secondary Outcomes (2)

• pain perception postoperatively

  up to one hour after discharge to postoperative unit.

• PONV

  up to one hour

Study Arms (5)

metamizol

EXPERIMENTAL

analgesic drug

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

acetaminophen

EXPERIMENTAL

analgesic drug

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

0,5 % bupivacaine with of 2% lidocaine

EXPERIMENTAL

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

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

Proxymetacaine

EXPERIMENTAL

topical analgesia

Drug: Acetaminophen; Drug: Proxymetacaine

control group

PLACEBO COMPARATOR

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

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

Interventions

Metamizol DRUG

in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram

acetaminophen; control group; metamizol

Acetaminophen DRUG

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

Also known as: paracetamol

0,5 % bupivacaine with of 2% lidocaine; Proxymetacaine; control group

0,5 % bupivacaine with of 2% lidocaine DRUG

in group PBB 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)

Also known as: Lidocaine

0,5 % bupivacaine with of 2% lidocaine; acetaminophen; control group; metamizol

Proxymetacaine DRUG

in group T patients will receive topical analgesia using a solution of 0,5% Alcaine

Also known as: Alcaine

0,5 % bupivacaine with of 2% lidocaine; Proxymetacaine; acetaminophen; control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• history of allergy to local anaesthetics or metamizole
• necessity of administration of vasoactive drugs influencing SPI monitoring
• pregnancy

Sponsors & Collaborators

• Medical University of Silesia: lead
• Silesian University of Medicine: collaborator

Study Sites (1)

Medical University of Silesia

Sosnowiec, Silesian Voivodeship, 41-200, Poland

Location

Related Publications (16)

• 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.

  PMID: 10486687 BACKGROUND

• 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 Jul 17.

  PMID: 25032676 RESULT

• Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker 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. Epub 2013 Mar 6.

  PMID: 23471754 RESULT

• 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.

  PMID: 24012235 RESULT

• 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: 10.1093/bja/aet485. Epub 2014 Feb 16.

  PMID: 24535604 RESULT

• 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.

  PMID: 25582785 RESULT

• 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.

  PMID: 22412772 RESULT

• Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.

  PMID: 17392852 RESULT

• 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. doi: 10.1177/112067210601600216.

  PMID: 16703549 RESULT

• Eberhart LH, Morin AM, Hoerle S, Wulf H, Geldner G. Droperidol and dolasetron alone or in combination for prevention of postoperative nausea and vomiting after vitrectomy. Ophthalmology. 2004 Aug;111(8):1569-75. doi: 10.1016/j.ophtha.2004.01.031.

  PMID: 15288990 RESULT

• 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. doi: 10.1053/rapm.2003.50032.

  PMID: 12567343 RESULT

• 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. doi: 10.1097/00006982-200112000-00010.

  PMID: 11756886 RESULT

• 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. doi: 10.1034/j.1600-0420.2000.078002196.x.

  PMID: 10794256 RESULT

• 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.

  PMID: 24404359 RESULT

• 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.

  PMID: 12355695 RESULT

• Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. doi: 10.2147/opth.s4935. Epub 2009 Nov 2.

  PMID: 19898665 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dipyrone; Acetaminophen; Lidocaine; proxymetacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anaesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)