Vitreoretinal SurgeriesSPIVSNCT02973581

SPI-directed Analgesia for Vitreoretinal Surgeries

A study testing Metamizol, Acetaminophen and 0,5 % bupivacaine with of 2% lidocaine in people with Vitreoretinal Surgeries and Postoperative Nausea and Vomiting, run by Medical University of Silesia at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain
What is being tested?: Metamizol, Acetaminophen and 0,5 % bupivacaine with of 2% lidocaine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 1 sitePoland
Study dates: Feb 2016to May 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

Medical University of Silesia
Sosnowiec, Silesian Voivodeship, 41-200

Other trials in Poland

About this study

Official title: Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial

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.

Read the 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.

Conditions: Vitreoretinal Surgeries, Postoperative Nausea and Vomiting, Postoperative Pain
Being tested: Metamizol, Acetaminophen, 0,5 % bupivacaine with of 2% lidocaine, Proxymetacaine
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
Medical subject headings: Postoperative Nausea and Vomiting, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetamizolDrug
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram
AcetaminophenDrug
Also called 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% lidocaineDrug
Also called Lidocaine
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)
ProxymetacaineDrug
Also called Alcaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine

Study groups in NCT02973581
Study group	Role	What they receive
metamizol	Experimental	analgesic drug Receives: Drug: Metamizol; Drug: 0,5 % bupivacaine with of 2% lidocaine
acetaminophen	Experimental	analgesic drug Receives: 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 Receives: Drug: Acetaminophen; Drug: 0,5 % bupivacaine with of 2% lidocaine; Drug: Proxymetacaine
Proxymetacaine	Experimental	topical analgesia Receives: Drug: Acetaminophen; Drug: Proxymetacaine
control group	Placebo comparator	patients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively. Receives: Drug: Metamizol; Drug: Acetaminophen; Drug: 0,5 % bupivacaine with of 2% lidocaine; Drug: Proxymetacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: intraoperatively
oculocardiac reflex rate
The investigators will compare the rate of presence of OCR intraoperatively in studied groups
Measured: intraoperatively

Secondary outcomes (2)

pain perception postoperatively
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.
Measured: up to one hour after discharge to postoperative unit.
PONV
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.
Measured: up to one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016May 2017

First posted25 Nov 2016 (estimated)
Study startFeb 2016
Primary completionFeb 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Vitreoretinal SurgeriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02973581
Sponsor's protocol ID: SilesianMUKOAiIT2
Acronym: SPIVS
Status last verified: Jul 2017
First submitted: 22 Nov 2016
Last updated: 23 Jan 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: article in European Journal of Anaesthesiology in 2018, case reports

Publications

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.
PubMed 10486687
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.
PubMed 25032676
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.
PubMed 23471754
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.
PubMed 24012235
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.
PubMed 24535604
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.
PubMed 25582785
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.
PubMed 22412772
Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.
PubMed 17392852
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.
PubMed 16703549
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.
PubMed 15288990
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.
PubMed 12567343
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.
PubMed 11756886
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.
PubMed 10794256
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.
PubMed 24404359
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.
PubMed 12355695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial
ClinicalTrials.gov ID: NCT02973581
Acronym / sponsor ID: SPIVS / SilesianMUKOAiIT2
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)
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Medical University of SilesiaUniversity, hospital or other
Collaborators: Silesian University of Medicine
Study start: Feb 2016 (actual)
Primary completion: Feb 2017 (actual)
Study completion: May 2017 (actual)
First posted: 25 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
metamizol	Experimental	Drug: Metamizol, Drug: 0,5 % bupivacaine with of 2% lidocaineanalgesic drug
acetaminophen	Experimental	Drug: Metamizol, Drug: 0,5 % bupivacaine with of 2% lidocaine, Drug: Proxymetacaineanalgesic drug
0,5 % bupivacaine with of 2% lidocaine	Experimental	Drug: Acetaminophen, Drug: 0,5 % bupivacaine with of 2% lidocaine, Drug: Proxymetacainea volume of 5 ml of analgesic solution for regional peribulbar block
Proxymetacaine	Experimental	Drug: Acetaminophen, Drug: Proxymetacainetopical analgesia
control group	Placebo comparator	Drug: Metamizol, Drug: Acetaminophen, Drug: 0,5 % bupivacaine with of 2% lidocaine, Drug: Proxymetacainepatients will receive no pre-emptive analgesia. standard doses of fentanyl will be used intraoperatively.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Metamizolin group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram	Drug	acetaminophen, control group, metamizol
AcetaminophenAlso: paracetamolin 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	Drug	0,5 % bupivacaine with of 2% lidocaine, Proxymetacaine, control group
0,5 % bupivacaine with of 2% lidocaineAlso: Lidocainein 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)	Drug	0,5 % bupivacaine with of 2% lidocaine, acetaminophen, control group, metamizol
ProxymetacaineAlso: Alcainein group T patients will receive topical analgesia using a solution of 0,5% Alcaine	Drug	0,5 % bupivacaine with of 2% lidocaine, Proxymetacaine, acetaminophen, control group

Primary outcome

pain perception intraoperatively
Time frame: 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
Time frame: intraoperatively
The investigators will compare the rate of presence of OCR intraoperatively in studied groups

2 secondary outcomes

pain perception postoperatively
Time frame: up to one hour after discharge to postoperative unit.
PONV
Time frame: up to one hour

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Background: PubMed 10486687Mandelcorn 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.
Results publication: PubMed 25032676Gruenewald 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.
Results publication: PubMed 23471754Gruenewald 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.
Results publication: PubMed 24012235Gruenewald 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.
Results publication: PubMed 24535604Gruenewald 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.
Results publication: PubMed 25582785Jaichandran 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.
Results publication: PubMed 22412772Ghali 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.
Results publication: PubMed 17392852Bahcecioglu H, Unal M, Artunay O, Rasier R, Sarici A. Posterior vitrectomy under topical anesthesia. Can J Ophthalmol. 2007 Apr;42(2):272-7.
Results publication: PubMed 16703549Seidenari 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.
Results publication: PubMed 15288990Eberhart 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.
Results publication: PubMed 12567343Subramaniam 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.
Results publication: PubMed 11756886Fekrat 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.
Individual participant dataSharing planned: Yes. article in European Journal of Anaesthesiology in 2018, case reports

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain perception intraoperatively (time frame: intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973581, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.