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The Prediction for Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03585088
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Nociceptive Pain Analgesia, Patient-Controlled Analgesics Device: surgical pleth index Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Arm Intervention/treatment
SPI Group
All patients who received the liver resection surgery will receive surgical pleth index
Device: surgical pleth index
All patients applied surgical pleth index after recovery of spontaneous breathing at the time of peritoneum and skin closure under Bispectral index score <=60.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score [ Time Frame: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase ]
    The consumption of patient controlled analgesia and intraoperative surgical pleth index score

  2. The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score [ Time Frame: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase ]
    The consumption of patient controlled analgesia and intraoperative surgical pleth index score

  3. The correlation of postoperative pain score and intraoperative nociception score [ Time Frame: awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours ]
    The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score

  4. The side effects of analgesics [ Time Frame: awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours ]
    nausea/vomiting, sedation, itching, respiratory depression



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585088


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center

Publications:
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03585088     History of Changes
Other Study ID Numbers: SMC2018-04-129
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Nociceptive Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms