Back to resultsEpidural Versus Continuous Wound Ropivacaine Infusion Analgesia
Primary Purpose
Postoperative Analgesia
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Epidural analgesia
Continuous wound infusion
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Analgesia focused on measuring Epidural analgesia, continuous wound infusion, ropivacaine, total abdominal hysterectomy
Eligibility Criteria
Inclusion Criteria:
Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -
Exclusion Criteria:
Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes
-
Sites / Locations
- Aretaieio Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epidural analgesia
Continuous wound infusion
Arm Description
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
The continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour.
Outcomes
Primary Outcome Measures
Postoperative morphine consumption
Postoperative morphine consumption
Postoperative morphine consumption
Postoperative morphine consumption
Postoperative morphine consumption
Postoperative morphine consumption
Postoperative morphine consumption
Postoperative morphine consumption
Secondary Outcome Measures
pain scores
pain scores
pain scores
pain scores
pain scores
pain scores
pain scores
pain scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01916473
Brief Title
Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia
Official Title
Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.
Detailed Description
The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia
Keywords
Epidural analgesia, continuous wound infusion, ropivacaine, total abdominal hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural analgesia
Arm Type
Active Comparator
Arm Description
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
Arm Title
Continuous wound infusion
Arm Type
Experimental
Arm Description
The continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour.
Intervention Type
Other
Intervention Name(s)
Epidural analgesia
Intervention Description
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
Intervention Type
Other
Intervention Name(s)
Continuous wound infusion
Intervention Description
Continuous wound infusion via catheter
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Time Frame
2 hours postoperatively
Title
Postoperative morphine consumption
Time Frame
4 hours postoperatively
Title
Postoperative morphine consumption
Time Frame
8 hours postoperatively
Title
Postoperative morphine consumption
Time Frame
24 hours postoperatively
Title
Postoperative morphine consumption
Time Frame
48 hours postoperatively
Title
Postoperative morphine consumption
Time Frame
72 hours postoperatively
Title
Postoperative morphine consumption
Time Frame
3 months postoperatively
Title
Postoperative morphine consumption
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
pain scores
Time Frame
2 hours postoperatively
Title
pain scores
Time Frame
4 hours postoperatively
Title
pain scores
Time Frame
8 hours postoperatively
Title
pain scores
Time Frame
24 hours postoperatively
Title
pain scores
Time Frame
48 hours postoperatively
Title
pain scores
Time Frame
72 hours postoperatively
Title
pain scores
Time Frame
3 months postoperatively
Title
pain scores
Time Frame
6 months postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -
Exclusion Criteria:
Age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, CNS disease or insulin dependent diabetes
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argyro Fassoulaki, MD,PhD, DEAA
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aretaieio Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
12. IPD Sharing Statement
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Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia
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