NCT03585088

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 degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

June 29, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
Last Updated

October 26, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

June 29, 2018

Last Update Submit

October 24, 2018

Conditions

Pain, PostoperativeNociceptive PainAnalgesia, Patient-ControlledAnalgesics

Outcome Measures

Primary Outcomes (1)

  • The correlation of requirement of postoperative analgesics for postoperative 24 hours and intraoperative nociception score

    The consumption of patient controlled analgesia and intraoperative surgical pleth index score

    intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 24 hour in postoperative phase

Secondary Outcomes (4)

  • The correlation of requirement of postoperative analgesics for postoperative 6 hours and intraoperative nociception score

    intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 6 hour in postoperative phase

  • The correlation of requirement of postoperative analgesics for postoperative 48 hours and intraoperative nociception score

    intraoperative nociception score: 3 minutes during closure peritoneum and skin; requirement of postoperative analgesics: the first 48 hour in postoperative phase

  • The correlation of postoperative pain score and intraoperative nociception score

    awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours

  • The side effects of analgesics

    awaken after general anesthesia in post-anesthesia care unit , postoperative 6, 24, 48 hours

Study Arms (1)

SPI Group

OTHER

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

Device: surgical pleth index

Interventions

surgical pleth indexDEVICE

All patients applied surgical pleth index after recovery of spontaneous breathing at the time of peritoneum and skin closure under Bispectral index score \<=60.

SPI Group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing liver resection (laparoscopic or laparotomy)

You may not qualify if:

  • patients who refused to participate patients who have cardiac arrythmia patients who have allergic history for remifentanil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

Location

Related Publications (3)

  • Dolin SJ, Cashman JN. Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention. Evidence from published data. Br J Anaesth. 2005 Nov;95(5):584-91. doi: 10.1093/bja/aei227. Epub 2005 Sep 16.

    PMID: 16169893BACKGROUND

  • Ledowski T, Sommerfield D, Slevin L, Conrad J, von Ungern-Sternberg BS. Surgical pleth index: prediction of postoperative pain in children? Br J Anaesth. 2017 Nov 1;119(5):979-983. doi: 10.1093/bja/aex300.

    PMID: 29028932BACKGROUND

  • 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

MeSH Terms

Conditions

Pain, PostoperativeNociceptive PainAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

June 30, 2018

Primary Completion

October 19, 2018

Study Completion

October 19, 2018

Last Updated

October 26, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)