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SurgicalPleth Index for the prediction of acute postoperative pain

SurgicalPleth Index for the prediction of acute postoperative pain

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001475336
Enrollment
200
Registered
2017-10-19
Start date
2017-11-30
Completion date
2018-10-01
Last updated
2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: The surgical pleth index (SPI, GE Healthcare, Helsinki, Finland) is a 0-100 score derived from the intraoperative non-invasive monitoring of oxygen saturation. Simply speaking, SPI is a software using existing data. The SPI score claims to reflect states of intraoperative pain. A previous investigation by us published in the British Journal of Anaesthesia (Br J Anaesth. 2016 Sep;117(3):371-4) found that a SPI > 30 at the end of surgery (prior to awakening) predicted moderate-severe postoperative pain. Objectives: As such prediction would provide a significant benefit for the pre-emptive treatment of pain, the proposed project aims to prospectively validate the SPI cut-off published by us in a larger cohort. In addition, we would like to evaluate the influence of age on the SPI cut-off value predicting moderate-severe pain, as well as the influence of a different anaesthetic technique (total intravenous anaesthesia) on the predictive value of SPI. The latter sub-group will be investigated by our collaborators in Kiel, Germany. Within WA Health 200 patients scheduled for non-emergency surgery under sevoflurane/opioid anaesthesia will be included in the study. Patients will receive a completely standard anaesthetic. At the end of surgery, SPI will be recorded minutely for 5 minutes. As outlined above, this simply requires recording of displayed SPI values. As SPI uses available data derived from standard monitoring, no discomfort or risk is associated with study inclusion. After awakening, 3 pain scores (numeric rating scales 0-10) will be recorded in the recovery room. The 5-minutely recording of pain scores is standard protocol in the involved hospitals and does hence not at all inconvenience patients. Apart from SPI and pain readings, only very limited data are recorded.

Interventions

Surgical Pleth Index will be recorded intraoperatively in 200 patients anaesthetized with sevoflurane/opioid during the last 5 minutes of an operation, just before the anaesthetic is lightened. Thereafter, postoperative pain will be recorded 3 times (for 15 minutes post recovery room admission) in the revcovery room (on a 0-10 numeric rating scale).

Sponsors

Thomas Ledowski
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Patients aged 18-100 yrs. scheduled for anaesthesia (non emergency) with sevoflurane/opioid.

Exclusion criteria

Regular or intraoperative medication (prior to SPI assessment) known or suspected to interact with the assessment of SPI (i.e. ketamine, clonidine, neostigmine, beta-receptor blockers, incl. metaraminol/ephedrine within 10 minutes of the SPI assessment), pacemaker, severe autonomous dysfunction, significant cardiac arrhythmia (i.e. AF), Aboriginal patients, patients with an impaired ability to rate their level of postoperative pain on a NRS (i.e. significant mental impairment, dementia), surgical tourniquet at the time of and/or < 10 minutes prior to SPI assessment, any analgesic medication between SPI assessment and first pain score in the recovery room (note: extremely rare)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026