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Completed

NCT Number: NCT03585088

The Prediction for Postoperative Pain

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.

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Key information

Conditions

Pain, Postoperative Agnosia Analgesia, Patient-Controlled Analgesics Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nociceptive Pain Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung medical center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical pleth index

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2018
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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