- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442961
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
April 9, 2013 updated by: Arvi Yli-Hankala, Tampere University Hospital
Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial
The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach.
The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy.
The primary outcome measurement is opioid consumption.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
188
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
-
-
-
Tampere, Finland
- Tampere University 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
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 18 -69 years
- Gender . female
- ASA status 1-3
- Vaginal hysterectomy or laparoscopic hysterectomy
Exclusion Criteria:
- Body mass Index over 35
- Diabetes Mellitus
- Liver disease
- Allergies to pharmaceuticals used in the Study
- Present use of opioids
- Vaginal prolapse
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: laparoscopy
Intervention: Procedure: laparoscopy
|
laparoscopic hysterectomy
|
Active Comparator: vaginal
Intervention: Procedure: vaginal
|
Vaginal hysterectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative consumption of an opioid (oxycodone)
Time Frame: 20 hours
|
the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump
|
20 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS (numeral rating scale) of pain
Time Frame: 20 hours
|
NRS is evaluated frequently during the study period.
|
20 hours
|
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
January 1, 2009
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
September 19, 2011
First Submitted That Met QC Criteria
September 28, 2011
First Posted (Estimate)
September 29, 2011
Study Record Updates
Last Update Posted (Estimate)
April 10, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R09003
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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