NCT03761433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

July 12, 2019

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 27, 2018

Last Update Submit

July 10, 2019

Conditions

Pain, PostoperativeNociceptive PainAnalgesics

Outcome Measures

Primary Outcomes (3)

  • The requirement of postoperative analgesics for postoperative 24 hours

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

    postoperative 24 hour

  • The immediate postoperative pain score

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

    postoperative 24 hour

  • intraoperative nociception score (surgical pleth index)

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

    intraoperative at the time of skin incision

Secondary Outcomes (2)

  • The correlation of requirement of summed postoperative analgesics and intraoperative nociception score

    postoperative 1 hour

  • The correlation of highest postoperative pain score and intraoperative nociception score

    postoperative 1 hour

Other Outcomes (2)

  • The expectation of postoperative pain

    The day before surgery

  • The expectation of analgesics consumption

    The day before surgery

Study Arms (1)

SPI group

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

Device: SPI group

Interventions

SPI groupDEVICE

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

SPI group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • undergoing laparotomy gastrectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 30390161BACKGROUND

  • 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.

    PMID: 23290256BACKGROUND

  • 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.

    PMID: 27543532BACKGROUND

  • 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.

    PMID: 28678075BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeNociceptive Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

December 3, 2018

Study Start

November 30, 2018

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

July 12, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)