Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

Not Applicable

Completed

• Conditions: Postoperative Analgesia
• Interventions: Other: Epidural analgesia; Other: Continuous wound infusion

• Registration Number: NCT01916473
• Lead Sponsor: University of Athens

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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-07-15
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-01
• Last Update Submitted: 2013-08-01
• Study First Posted: 2013-08-05
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural analgesia	Epidural analgesia	Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
Continuous wound infusion	Continuous wound infusion	The continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour.

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
pain scores	6 months postoperatively

Trial Locations

Locations (1)

Aretaieio Hospital; 🇬🇷 Athens, Greece