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CompletedNCT03761433Updated Jul 12, 2019

Intraoperative Nociception and Postoperative Pain

An observational study in Pain, Postoperative, Nociceptive Pain and Analgesics, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Pain, Postoperative
  • Nociceptive Pain
  • Analgesics
03

In context

Pain, Postoperative

5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 622 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

the 20-80 year old patients who undergoing lapatotomy gastrectomy at samsung medical center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-undergoing laparotomy gastrectomy

Exclusion criteria

Exclusion Criteria:

  • cardiac arrythmia
  • allergic history for drugs
  • renal failure (Cr> 1.5 mg/dl)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • SPI group

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

    Device: SPI group

Interventions

  • DeviceSPI group

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

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What researchers measure

Primary outcomes

  1. The requirement of postoperative analgesics for postoperative 24 hours

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

    Time frame: postoperative 24 hour

  2. The immediate postoperative pain score

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

    Time frame: postoperative 24 hour

  3. intraoperative nociception score (surgical pleth index)

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

    Time frame: intraoperative at the time of skin incision

Secondary outcomes

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

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

    Time frame: postoperative 1 hour

  2. The correlation of highest 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

    Time frame: postoperative 1 hour

Other outcomes

  1. The expectation of postoperative pain

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

    Time frame: The day before surgery

  2. The expectation of analgesics consumption

    less than average, average, more than average

    Time frame: The day before surgery

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Study locations

1 site
  • Samsung medical center
    Seoul, 06351, South Korea
08

References and documents

Publications

  • Robertson TC, Hall K, Bear S, Thompson KJ, Kuwada T, Gersin KS. Transversus abdominis block utilizing liposomal bupivacaine as a non-opioid analgesic for postoperative pain management. Surg Endosc. 2019 Aug;33(8):2657-2662. doi: 10.1007/s00464-018-6543-z. Epub 2018 Nov 2. PubMed 30390161 ↗
  • Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5. PubMed 23290256 ↗
  • 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. PubMed 27543532 ↗
  • 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. PubMed 28678075 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03761433
Responsible party
Sponsor
First posted
Dec 3, 2018
Start date
Nov 30, 2018
Primary completion
May 20, 2019
Completion
May 20, 2019
Last update
Jul 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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