NCT03021447

Brief Summary

Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity. Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity. Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
unknown

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

Study Start

First participant enrolled

January 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

January 12, 2017

Last Update Submit

January 13, 2017

Conditions

Cholecystitis, Acute

Outcome Measures

Primary Outcomes (1)

  • postoperative pain intensity_1

    Postoperative pain will be evaluated with verbal numeric scale (0-10)

    10 min after postanesthesia care unit admission

Secondary Outcomes (6)

  • postoperative pain intensity_2

    20 min after postanesthesia care unit admission

  • postoperative pain intensity_3

    30 min after postanesthesia care unit admission

  • postoperative pain intensity_4

    4 hours after operation

  • postoperative pain intensity_8

    8 hours after operation

  • postoperative pain intensity_12

    12 hours after operation

  • +1 more secondary outcomes

Eligibility Criteria

Age19 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients scheduled for laparoscopic cholecystectomy will be included.

You may qualify if:

  • America Society of Anesthesiologists class I-II
  • Laparoscopic cholecystectomy

You may not qualify if:

  • Pregnancy
  • Illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share