Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
laparoscopy, laparoscopic hysterectomy
vaginal : vaginal hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring pain, postoperative, hysterectomy, vaginal, surgery, gynecological
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laparoscopy
vaginal
Arm Description
Intervention: Procedure: laparoscopy
Intervention: Procedure: vaginal
Outcomes
Primary Outcome Measures
Postoperative consumption of an opioid (oxycodone)
the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump
Secondary Outcome Measures
NRS (numeral rating scale) of pain
NRS is evaluated frequently during the study period.
Full Information
NCT ID
NCT01442961
First Posted
September 19, 2011
Last Updated
April 9, 2013
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01442961
Brief Title
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
Official Title
Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain, postoperative, hysterectomy, vaginal, surgery, gynecological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopy
Arm Type
Active Comparator
Arm Description
Intervention: Procedure: laparoscopy
Arm Title
vaginal
Arm Type
Active Comparator
Arm Description
Intervention: Procedure: vaginal
Intervention Type
Procedure
Intervention Name(s)
laparoscopy, laparoscopic hysterectomy
Intervention Description
laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
vaginal : vaginal hysterectomy
Intervention Description
Vaginal hysterectomy
Primary Outcome Measure Information:
Title
Postoperative consumption of an opioid (oxycodone)
Description
the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump
Time Frame
20 hours
Secondary Outcome Measure Information:
Title
NRS (numeral rating scale) of pain
Description
NRS is evaluated frequently during the study period.
Time Frame
20 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
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