Skip to main content
OpenTrials
Completed

NCT Number: NCT03761433

Intraoperative Nociception and Postoperative Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Analgesics Neurologic Manifestations Nociceptive Pain Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung medical center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-undergoing laparotomy gastrectomy

Exclusion criteria

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

Treatment and study plan

SPI group

Device

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

Primary outcomes

  1. The requirement of postoperative analgesics for postoperative 24 hours

    Time frame: postoperative 24 hour

    The requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)

  2. The immediate postoperative pain score

    Time frame: postoperative 24 hour

    The numeric rating pain score, no pain=0 ~ worst pain=10

  3. intraoperative nociception score (surgical pleth index)

    Time frame: intraoperative at the time of skin incision

    under End tidal sevoflurane 3%, surgical pleth index score following surgical incision

Secondary outcomes

  1. The correlation of requirement of summed postoperative analgesics and intraoperative nociception score

    Time frame: postoperative 1 hour

    The consumption of analgesics (opioid conversion to fentanyl dose mcg) and intraoperative surgical pleth index value

  2. The correlation of highest postoperative pain score and intraoperative nociception score

    Time frame: postoperative 1 hour

    The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score

Other outcomes

  1. The expectation of postoperative pain

    Time frame: The day before surgery

    The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)

  2. The expectation of analgesics consumption

    Time frame: The day before surgery

    less than average, average, more than average

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2018
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.