The Prediction for Postoperative Pain

Not Applicable

Completed

• Conditions: Analgesics; Pain, Postoperative; Analgesia, Patient-Controlled; Nociceptive Pain
• Interventions: Device: surgical pleth index

• Registration Number: NCT03585088
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Study Start: 2018-06-30
• Study First Posted: 2018-07-12
• Primary Completion: 2018-10-19
• Study Completion: 2018-10-19
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPI Group	surgical pleth index	All patients who received the liver resection surgery will receive surgical pleth index

Primary Outcome Measures

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

Name	Time	Method
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 consumption of patient controlled analgesia and intraoperative surgical pleth index score
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 consumption of patient controlled analgesia and intraoperative surgical pleth index score
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 postoperative pain score (numeric rating pain score, no pain=0\~ worst pain=10)and intraoperative surgical pleth index score
The side effects of analgesics	awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours	nausea/vomiting, sedation, itching, respiratory depression

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of