Benign Gynecological DiseaseNCT04793191
Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain
An observational study of Benign Gynecological Disease, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Benign Gynecological Disease
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2021to 15 Feb 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: the women scheduled for elective gynecological laparoscopy in the tertiary care clinic
Who may be able to join
- women scheduled for elective gynecological laparoscopy
Who cannot join
- psychiatric disease eg. anxiety, depression, etc.
- diagnosed as cancer
- the use of vasoactive drug
- chronic pain except lower back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain in the Gynecological Laparoscopy
To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy
- Conditions
- Benign Gynecological Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
the intensity of acute postoperative pain
The intensity of pain is assessed using the numeric rating scale (0=no pain; 10=the worst pain)
Measured: during 30 min in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start20 Mar 2021
- Primary completion31 Jan 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Gynecological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Young Eun Moon, MD, PhD, Principal investigator, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793191
- Sponsor's protocol ID
- back pain
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain in the Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT04793191
- Acronym / sponsor ID
- back pain
- Conditions
- Benign Gynecological Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the women scheduled for elective gynecological laparoscopy in the tertiary care clinic
Key inclusion criteria (1 listed)
- women scheduled for elective gynecological laparoscopy
Key exclusion criteria (4 listed)
- psychiatric disease eg. anxiety, depression, etc.
- diagnosed as cancer
- the use of vasoactive drug
- chronic pain except lower back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the intensity of acute postoperative pain
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Eun Moon, MD, PhD principal investigator
Department of Anesthesiology and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Gynecological Disease, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the intensity of acute postoperative pain (time frame: during 30 min in the recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.