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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04724564
Other study ID # M 703
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 1, 2021

Study information

Verified date January 2022
Source Fayoum University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Despite the major progress in anesthetic techniques, postoperative pain is still considered a major problem during practice. (1-3). Leading to many co-morbidities, one to two-thirds of patients will suffer postoperative pain. These co-morbidities can include; pulmonary complications, cardiac complications, and delirium(4). Numerous risk factors are associated with the emergence of postoperative pain, including; younger age, female sex, preoperative pain, and extensive surgical procedure. The severity of postoperative pain may vary among patients undergoing the same operation (5-10). Many techniques have been evolved to monitor nociception and predict postoperative pain intensity; one of the most recent techniques is the surgical pleth index (SPI)(11).SPI is a noninvasive dimensionless score; its value is obtained from heartbeat interval and pulse wave amplitude monitored by pulse oximetry probe.SPI reflects the sympathetic response of the patient to the surgical stimuli(12-13). It was reported that SPI is better than other parameters like heart rate and blood pressure for detecting the balance between nociceptor activation and analgesia(14-15), and its value is correlated with the severity of postoperative pain. SPI values range from 0 to 100, and higher values indicate strong surgical stimulus (16). SPI can be used as a guide for intraoperative analgesia; hence, it can be a valuable tool to assess the analgesic requirement and limit opioid consumption, both preoperative and postoperative(17). Several studies have been performed to predict the severity of postoperative pain using SPI in adults and children (16,18). It was also used successfully to expect a hemodynamic response to tracheal intubation and skin incision (19) and monitor nerve block success. (20). However, since SPI has emerged, the most sensitive cut-off value that correlates well with postoperative pain severity remained debatable. Recent studies reported a value of 30 as a cut-off value of SPI. (21). On the other hand, the time of measurement to rely on was debatable. Most studies recommended that a measure of SPI before recovery can be used. However, a more recent study suggested that SPI response to surgical incision is highly correlated with postoperative pain and opioid consumption (18). Based on these data, we hypothesized that both measurements are correlated with postoperative pain and aimed to test which measure is more correlated.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
THE SURGICAL PLETH INDEX
CORRELATION OF DIFFERENT TIME MEASUREMENTS OF THE SURGICAL PLETH INDEX WITH POSTOPERATIVE PAIN

Locations

Country Name City State
Egypt Fayoum University hospital Fayoum Faiyum Governorate

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. — View Citation

Jung K, Park MH, Kim DK, Kim BJ. Prediction of Postoperative Pain and Opioid Consumption Using Intraoperative Surgical Pleth Index After Surgical Incision: An Observational Study. J Pain Res. 2020 Nov 6;13:2815-2824. doi: 10.2147/JPR.S264101. eCollection 2020. — View Citation

Persson AK, Dyrehag LE, Åkeson J. Prediction of Postoperative Pain From Electrical Pain Thresholds After Laparoscopic Cholecystectomy. Clin J Pain. 2017 Feb;33(2):126-131. doi: 10.1097/AJP.0000000000000394. — View Citation

Persson AKM, Åkeson J. Prediction of Acute Postoperative Pain from Assessment of Pain Associated With Venous Cannulation. Pain Pract. 2019 Feb;19(2):158-167. doi: 10.1111/papr.12729. Epub 2018 Nov 5. — View Citation

Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary which SPI measurement is more correlated with postoperative pain The primary outcome is to determine which SPI measurement is more correlated with postoperative pain SPI at 5 minutes after skin incision and 10 minutes before recovery
Secondary the correlation between the SPI measurements and opioid consumption the correlation between the SPI measurements and opioid consumption the first postoperative 24 hours
Secondary the cut-off value of SPI measurements to define the cut-off value of SPI measurements SPI at 5 minutes after skin incision and 10 minutes before recovery
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