The Prediction for Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

Can we Predict Postoperative Analgesic Requirement by Intraoperative Nociception?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585088
• Other study ID #: SMC2018-04-129
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: May 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia, Patient-Controlled
• Analgesics
• Nociceptive Pain
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. Epub 2005 Sep 16. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score	The consumption of patient controlled analgesia and intraoperative surgical pleth index score	intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 24 hour in postoperative phase
Secondary	The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score	The consumption of patient controlled analgesia and intraoperative surgical pleth index score	intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase
Secondary	The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score	The consumption of patient controlled analgesia and intraoperative surgical pleth index score	intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase
Secondary	The correlation of postoperative pain score and intraoperative nociception score	The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score	awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours
Secondary	The side effects of analgesics	nausea/vomiting, sedation, itching, respiratory depression	awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours