Postoperative Analgesia Clinical Trial
Official title:
Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial
Verified date | August 2013 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Interventional |
Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.
Status | Completed |
Enrollment | 80 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Aretaieio Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative morphine consumption | 2 hours postoperatively | Yes | |
Primary | Postoperative morphine consumption | 4 hours postoperatively | Yes | |
Primary | Postoperative morphine consumption | 8 hours postoperatively | Yes | |
Primary | Postoperative morphine consumption | 24 hours postoperatively | Yes | |
Primary | Postoperative morphine consumption | 48 hours postoperatively | Yes | |
Primary | Postoperative morphine consumption | 72 hours postoperatively | Yes | |
Primary | Postoperative morphine consumption | 3 months postoperatively | Yes | |
Primary | Postoperative morphine consumption | 6 months postoperatively | Yes | |
Secondary | pain scores | 2 hours postoperatively | Yes | |
Secondary | pain scores | 4 hours postoperatively | Yes | |
Secondary | pain scores | 8 hours postoperatively | Yes | |
Secondary | pain scores | 24 hours postoperatively | Yes | |
Secondary | pain scores | 48 hours postoperatively | Yes | |
Secondary | pain scores | 72 hours postoperatively | Yes | |
Secondary | pain scores | 3 months postoperatively | Yes | |
Secondary | pain scores | 6 months postoperatively | Yes |
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