- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01838382
Pain Characteristics After Total Laparoscopic Hysterectomy
January 12, 2014 updated by: Yonsei University
Laparoscopic operative procedures have revolutionized gynecological surgery.
These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs.
However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge.
There are few studies about pain characteristics as one of laparoscopic hysterectomy complications.
The purpose of this study is to investigate the prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in patients undergoing total laparoscopic hysterectomy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ASA I or II
- age >=20, <= 80 years
- female
- patients undergoing elective total laparoscopic hysterectomy
Exclusion Criteria:
- age < 19 years or > 80 years
- abnormal mental status
- drug abuse
- chronic alcoholism
- immunosuppressants or steroid user
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: laparoscopic hysterectomy group
female patients undergoing total laparoscopic hysterectomy.
|
Classic LMA (cLMA) will be inserted when no response is obtained in the train-of-four stimulation.
The fiberoptic view through the LMA, intraoperative complications of the cLMA, any complication during anesthesia emergence will be recorded.
The device is examined and noted for the presence of visible blood.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall pain
Time Frame: 3 days
|
evaluated with visual analogue score (VAS)
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
April 16, 2013
First Submitted That Met QC Criteria
April 23, 2013
First Posted (Estimate)
April 24, 2013
Study Record Updates
Last Update Posted (Estimate)
January 14, 2014
Last Update Submitted That Met QC Criteria
January 12, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4-2012-0871
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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