Correlation of Different Time Measurements of the Surgical PLETH Index With Postoperative Pain

NCT04724564 | Completed

• 1 other identifier: M 703
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Hysterectomy

Keywords

Hysterectomy; Analgesic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the correlation between the SPI measurements and opioid consumption

  the first postoperative 24 hours

• the cut-off value of SPI measurements

  SPI at 5 minutes after skin incision and 10 minutes before recovery

Interventions

THE SURGICAL PLETH INDEX DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 18-65 year
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted in Fayoum uniersity hospital who are candidates for elective abdominal hysterectomy under general anesthesia and their age range from 18-65

You may qualify if:

• elective abdominal hysterectomy under general anesthesia and their age range from 18-65

You may not qualify if:

• an age \<18 years
• significant dysrhythmia like AF or atrioventricular block more than1st degree
• patient with a pacemaker
• treatment with vasoactive medications, and any intraoperative treatment with clonidine, beta-receptor agonists or antagonists, or any other drug that can affect the sympathovagal balance.
• Patients receiving neuraxial anesthesia

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related 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.

  PMID: 23392233 BACKGROUND

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

  PMID: 26509324 BACKGROUND

• Persson AK, Dyrehag LE, Akeson 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.

  PMID: 27258997 BACKGROUND

• Persson AKM, Akeson 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.

  PMID: 30269418 BACKGROUND

• 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.

  PMID: 33192089 BACKGROUND

Study Officials

• Mohamed A Hamed, MD

  Fayoum University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: February 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 1, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)