NCT04793191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

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

March 9, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

March 20, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 9, 2021

Last Update Submit

March 10, 2022

Conditions

Benign Gynecological Disease

Outcome Measures

Primary Outcomes (1)

  • the intensity of acute postoperative pain

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

    during 30 min in the recovery room

Eligibility Criteria

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

the women scheduled for elective gynecological laparoscopy in the tertiary care clinic

You may qualify if:

  • women scheduled for elective gynecological laparoscopy

You may not qualify if:

  • psychiatric disease eg. anxiety, depression, etc.
  • diagnosed as cancer
  • the use of vasoactive drug
  • chronic pain except lower back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, Seocho-gu, 07651, South Korea

Location

Study Officials

  • Young Eun Moon, MD, PhD

    Department of Anesthesiology and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 11, 2021

Study Start

March 20, 2021

Primary Completion

January 31, 2022

Study Completion

February 15, 2022

Last Updated

March 14, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)