SPI-directed Analgesia for Vitreoretinal Surgeries

Postoperative Pain Clinical Trial

— SPIVS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973581
• Other study ID #: SilesianMUKOAiIT2
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: January 18, 2018
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 2017
• Est. primary completion date: February 2017
• 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 metamizole

• necessity of administration of vasoactive drugs influencing SPI monitoring

• pregnancy

Related Conditions & MeSH terms

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

Intervention

Drug:
• Metamizol
in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram
• Acetaminophen
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 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)
• Proxymetacaine
in group T patients will receive topical analgesia using a solution of 0,5% Alcaine

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 (16)

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

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

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. — 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

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. Epub 2009 Nov 2. — 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 16 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. 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
Primary	oculocardiac reflex rate	The investigators will compare the rate of presence of OCR intraoperatively in studied groups	intraoperatively
Secondary	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.	up to one hour after discharge to postoperative unit.
Secondary	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.	up to one hour