Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

Study Overview
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Brief Summary
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Study Hypothesis: The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.

Detailed Description
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The analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.

Official Title
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Epidural Versus Continuous Wound Ropivacaine Infusion: Effect on Acute and Chronic Pain After Myomectomy or Total Abdominal Hysterectomy. A Randomized Controlled Trial

Conditions
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Postoperative Analgesia

Intervention / Treatment
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* Other: Epidural analgesia
* Other: Continuous wound infusion


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural analgesia<br>Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly | Other: Epidural analgesia<br>* Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly<br>|
| Experimental: Continuous wound infusion<br>The continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour. | Other: Continuous wound infusion<br>* Continuous wound infusion via catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine consumption |  | 2 hours postoperatively | 
| Postoperative morphine consumption |  | 4 hours postoperatively | 
| Postoperative morphine consumption |  | 8 hours postoperatively | 
| Postoperative morphine consumption |  | 24 hours postoperatively | 
| Postoperative morphine consumption |  | 48 hours postoperatively | 
| Postoperative morphine consumption |  | 72 hours postoperatively | 
| Postoperative morphine consumption |  | 3 months postoperatively | 
| Postoperative morphine consumption |  | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores |  | 2 hours postoperatively | 
| pain scores |  | 4 hours postoperatively | 
| pain scores |  | 8 hours postoperatively | 
| pain scores |  | 24 hours postoperatively | 
| pain scores |  | 48 hours postoperatively | 
| pain scores |  | 72 hours postoperatively | 
| pain scores |  | 3 months postoperatively | 
| pain scores |  | 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural analgesia, continuous wound infusion, ropivacaine, total abdominal hysterectomy