Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

Postoperative Pain Clinical Trial

— P&MSPIVRS  

Official title:

Influence of SPI-guided Analgesia With Preemptive Analgesia Using Either Paracetamol or Metamizole on the Presence of Oculocardiac Reflex, Postoperative Pain, Postoperative Nausea and Vomiting in Patients Undergoing VRS Under General Anaesthesia: a Randomised, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389243
• Other study ID #: SilesianMUKOAiIT7
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 16, 2022

Study information

• Verified date: January 2022
• 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 preemptive analgesia using paracetamol or metamizole or both of them 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 preemptive analgesia using preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of 1,0 g of acetaminophen or both of them together.

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 preemptive analgesia are used to decrease the postoperative pain perception as well as diminish the rate of PONV by deceasing intraoperative consumption of intravenous narcotic analgesics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 16, 2022
• Est. primary completion date: September 16, 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 paracetamol 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 M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
• paracetamol
in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
• paracetamol and metamizole
in group PM patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram and paracetamol in a dose of 1 gram

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 (6)

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. — 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, 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. — 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. — 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain perception intraoperatively	The investigators will compare the efficacy of analgesia intraoperatively according to used preoperatively intravenous infusions . 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 10 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
Secondary	pain perception postoperatively	The investigators will compare the efficacy of analgesia postoperatively according to technique of analgesia used preoperatively: intravenous infusion of either metamizol or paracetamol or both of them. 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 24 hours
Secondary	oculocardiac reflex rate	The investigators will compare the rate of presence of OCR intraoperatively in studied groups	intraoperatively