Clinical trial NCT03585088: The Prediction for Postoperative Pain
Official title: Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Nociceptive Pain
Analgesia, Patient-Controlled
Analgesics
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score
timeFrame: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 24 hour in postoperative phase
Secondary outcomes:
measure: The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score
timeFrame: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase
measure: The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score
timeFrame: intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase
measure: The correlation of postoperative pain score and intraoperative nociception score
timeFrame: awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours
measure: The side effects of analgesics
timeFrame: awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
citation: Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.
citation: Ledowski T, Sommerfield D, Slevin L, Conrad J, von Ungern-Sternberg BS. Surgical pleth index: prediction of postoperative pain in children? Br J Anaesth. 2017 Nov 1;119(5):979-983. doi: 10.1093/bja/aex300.
citation: Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.