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Clinical Trials/NCT03585088
NCT03585088
Completed
Not Applicable

Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?

Samsung Medical Center1 site in 1 country53 target enrollmentJune 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Samsung Medical Center
Enrollment
53
Locations
1
Primary Endpoint
The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

Detailed Description

Post-operative pain not only alleviates patient discomfort, but also delays recovery and thus prolongs the hospital stay. There are many ways to control postoperative pain, but analgesic infusion through venous route, patient controlled analgesia (PCA), especially narcotic analgesics, is often used to control the infusion when needed. However, because PCA is based on only age, weight, and underlying diseases, there are limitations in effective analgesia, and excessive sedation due to excessive infusion. Therefore, if the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. The noxious stimuli during surgery may have a negative effect on the healing process and surgical outcome of the wound due to stress reaction and catabolism, secretion of pituitary hormone, activation of the sympathetic nervous system, and immunological changes. Therefore, proper analgesia is needed during general anesthesia. A non-invasive, non-invasive analgesic device is currently available for Surgical pleth index (SPI) to assess the status of intraoperative analgesia. SPI = 100- (0.3 \* heart beat interval + 0.7 \* photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation. In the postoperative pain prediction study with SPI, the SPI value at the end of the operation was found to be proportional to the pain in the recovery room. However, only the pain score immediately after the operation was confirmed in these studies. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

Registry
clinicaltrials.gov
Start Date
June 30, 2018
End Date
October 19, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • undergoing liver resection (laparoscopic or laparotomy)

Exclusion Criteria

  • patients who refused to participate patients who have cardiac arrythmia patients who have allergic history for remifentanil

Outcomes

Primary Outcomes

The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score

Time Frame: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 24 hour in postoperative phase

The consumption of patient controlled analgesia and intraoperative surgical pleth index score

Secondary Outcomes

  • The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score(intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase)
  • The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score(intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase)
  • The correlation of postoperative pain score and intraoperative nociception score(awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours)
  • The side effects of analgesics(awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours)

Study Sites (1)

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