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Clinical Trials/NCT04724564
NCT04724564CompletedNot Applicable

Correlation of Different Time Measurements of the Surgical PLETH Index With Postoperative Pain; a Prospective Observational Study

Fayoum University Hospital1 site in 1 country99 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
99
Locations
1
Primary Endpoint
which SPI measurement is more correlated with postoperative pain

Study Overview

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.

Detailed Description

The current study's objective is to determine the optimum time to measure intraoperative SPI, which correlates better with postoperative pain.

Methods:

The study will be performed at Fayoum university hospital after the local institutional ethics committee and local institutional review board's approval. The study design will be a prospective observational study.A total of 99 patients scheduled for elective abdominal hysterectomy under general anesthesia and their age range from 18-65 will be included in this trial.

Exclusion criteria included; 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 t reatment with clonidine, beta-receptor agonists or antagonists, or anyother drug that can affect the sympathovagal balance.patients receiving neuraxial anesthesia will also be excluded.

Anesthesia and pain management:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

which SPI measurement is more correlated with postoperative pain

Time Frame: SPI at 5 minutes after skin incision and 10 minutes before recovery

The primary outcome is to determine which SPI measurement is more correlated with postoperative pain

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Ahmed Hamed

Associate Professor of Anesthesiology

Fayoum University Hospital

Study Sites (1)

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