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Pain, PostoperativeNCT03761433

Intraoperative Nociception and Postoperative Pain

An observational study of Pain, Postoperative and Nociceptive Pain, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Pain, Postoperative, Nociceptive Pain, Analgesics
What is being tested?
SPI group
Type of treatment
Medical device
How many people
50 participants
Where
1 siteSouth Korea
Study dates
30 Nov 2018to 20 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • -undergoing laparotomy gastrectomy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung medical center

    Seoul, 06351

Other trials in South Korea

About this study

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

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.

Being tested
SPI group
Medical subject headings
Pain, Postoperative, Nociceptive Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPI groupDevice

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

Study groups in NCT03761433
Study groupRoleWhat they receive
SPI groupAll patients who received the liver resection surgery will receive surgical pleth index
Receives: Device: SPI group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: postoperative 24 hour

  2. The immediate postoperative pain score

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

    Measured: postoperative 24 hour

  3. intraoperative nociception score (surgical pleth index)

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

    Measured: intraoperative at the time of skin incision

Secondary outcomes (2)

  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

    Measured: 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

    Measured: postoperative 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start30 Nov 2018
  3. Primary completion20 May 2019
  4. Study completion20 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761433
Sponsor's protocol ID
SMC2018-11-118
Status last verified
Nov 2018
First submitted
27 Nov 2018
Last updated
12 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Postoperative and Nociceptive Pain, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The requirement of postoperative analgesics for postoperative 24 hours (time frame: postoperative 24 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03761433, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.

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