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Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain

Sponsor
The Catholic University of Korea (Other)
Overall Status
Completed
CT.gov ID
NCT04793191
Collaborator
(none)
150
Enrollment
1
Location
10.9
Actual Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain in the Gynecological Laparoscopy
    Actual Study Start Date :
    Mar 20, 2021
    Actual Primary Completion Date :
    Jan 31, 2022
    Actual Study Completion Date :
    Feb 15, 2022

    Outcome Measures

    Primary Outcome Measures

    1. the intensity of acute postoperative pain [during 30 min in the recovery room]

      The intensity of pain is assessed using the numeric rating scale (0=no pain; 10=the worst pain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • women scheduled for elective gynecological laparoscopy
    Exclusion Criteria:

    • psychiatric disease eg. anxiety, depression, etc.

    • diagnosed as cancer

    • the use of vasoactive drug

    • chronic pain except lower back pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul St.Mary's Hospital Seoul Seocho-gu Korea, Republic of 07651

    Sponsors and Collaborators

    • The Catholic University of Korea

    Investigators

    • Principal Investigator: Young Eun Moon, MD, PhD, Department of Anesthesiology and Pain Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Young Eun Moon, Associate professor, The Catholic University of Korea
    ClinicalTrials.gov Identifier:
    NCT04793191
    Other Study ID Numbers:
    • back pain
    First Posted:
    Mar 11, 2021
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Back Pain
    Pain, Postoperative
    Low Back Pain

    Study Results

    No Results Posted as of Mar 14, 2022