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Intraoperative Nociception and Postoperative Pain

the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03761433
Enrollment
50
Registered
2018-12-03
Start date
2018-11-30
Completion date
2019-05-20
Last updated
2019-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesics, Nociceptive Pain, Pain, Postoperative

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.

Interventions

DEVICESPI group

All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

-undergoing laparotomy gastrectomy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The immediate postoperative pain scorepostoperative 24 hourThe numeric rating pain score, no pain=0 \ worst pain=10
The requirement of postoperative analgesics for postoperative 24 hourspostoperative 24 hourThe requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)
intraoperative nociception score (surgical pleth index)intraoperative at the time of skin incisionunder End tidal sevoflurane 3%, surgical pleth index score following surgical incision

Secondary

MeasureTime frameDescription
The correlation of highest postoperative pain score and intraoperative nociception scorepostoperative 1 hourThe postoperative pain score (numeric rating pain score, no pain=0\ worst pain=10)and intraoperative surgical pleth index score
The correlation of requirement of summed postoperative analgesics and intraoperative nociception scorepostoperative 1 hourThe consumption of analgesics (opioid conversion to fentanyl dose mcg) and intraoperative surgical pleth index value

Other

MeasureTime frameDescription
The expectation of postoperative painThe day before surgeryThe postoperative pain score (numeric rating pain score, no pain=0\ worst pain=10)
The expectation of analgesics consumptionThe day before surgeryless than average, average, more than average

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026