Clinical trial NCT03761433: Intraoperative Nociception and Postoperative Pain
Official title: the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Nociceptive Pain
Analgesics
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the 20-80 year old patients who undergoing lapatotomy gastrectomy at 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 relation intraoperative nociception response with postoperative pain score.

In similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index values for stimulus of skin incision are thought to reflect the individual nociception characteristics.

Detailed description: Patients who undergoing upper abdominal laparotomy surgery usually experience severe postoperative pain. Previous studies were reported that preoperative pain, young age, high-dose remifentanil, and depression were associated with severe postoperative pain.

However, anesthesia-related studies were either retrospective studies or injected with anesthetic agents in excess of clinical doses to differentiate between groups. There is no objective indicator for prediction severe postoperative pain.The purpose of this study was to investigate the relationship between intraoperative pain response and postoperative pain on standardized surveillance devices.

To maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used. Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive pain-analgesia balance monitoring device that is commercially available to evaluate the state of pain during general anesthesia. 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 similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of skin incision are thought to reflect the individual nociception characteristics. The investigators hypothesized the higher analgesics consumption can predict with high SPI response following incisional stimuli.

Thus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth, hemodynamically stable and appropriate anesthetic depth based on previous studies were confirmed at the time of skin incision). And the characteristics and emotional status of patients in two groups are compared.

Eligibility criteria: Inclusion Criteria:

-undergoing laparotomy gastrectomy

Exclusion Criteria:

* cardiac arrythmia
* allergic history for drugs
* renal failure (Cr\> 1.5 mg/dl)

Primary outcomes:
measure: The requirement of postoperative analgesics for postoperative 24 hours
timeFrame: postoperative 24 hour
measure: The immediate postoperative pain score
timeFrame: postoperative 24 hour
measure: intraoperative nociception score (surgical pleth index)
timeFrame: intraoperative at the time of skin incision
Secondary outcomes:
measure: The correlation of requirement of summed postoperative analgesics and intraoperative nociception score
timeFrame: postoperative 1 hour
measure: The correlation of highest postoperative pain score and intraoperative nociception score
timeFrame: postoperative 1 hour
Other outcomes:
measure: The expectation of postoperative pain
timeFrame: The day before surgery
measure: The expectation of analgesics consumption
timeFrame: The day before surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
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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.
citation: Baron-Stefaniak J, Gotz V, Allhutter A, Schiefer J, Hamp T, Faybik P, Berlakovich G, Baron DM, Plochl W. Patients Undergoing Orthotopic Liver Transplantation Require Lower Concentrations of the Volatile Anesthetic Sevoflurane. Anesth Analg. 2017 Sep;125(3):783-789. doi: 10.1213/ANE.0000000000002250.