Intraoperative Nociception and Postoperative Pain

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03761433
Collaborator
(none)
50
1
5.6
8.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SPI group

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.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy
Actual Study Start Date :
Nov 30, 2018
Actual Primary Completion Date :
May 20, 2019
Actual Study Completion Date :
May 20, 2019

Arms and Interventions

Arm Intervention/Treatment
SPI group

All patients who received the liver resection surgery will receive surgical pleth index

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

Outcome Measures

Primary Outcome Measures

  1. The requirement of postoperative analgesics for postoperative 24 hours [postoperative 24 hour]

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

  2. The immediate postoperative pain score [postoperative 24 hour]

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

  3. intraoperative nociception score (surgical pleth index) [intraoperative at the time of skin incision]

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

Secondary Outcome Measures

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

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

Other Outcome Measures

  1. The expectation of postoperative pain [The day before surgery]

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

  2. The expectation of analgesics consumption [The day before surgery]

    less than average, average, more than average

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

-undergoing laparotomy gastrectomy

Exclusion Criteria:
  • cardiac arrythmia

  • allergic history for drugs

  • renal failure (Cr> 1.5 mg/dl)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung medical center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03761433
Other Study ID Numbers:
  • SMC2018-11-118
First Posted:
Dec 3, 2018
Last Update Posted:
Jul 12, 2019
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2019