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Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

NCT ID: NCT01916473

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-11-30

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.

Conditions

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Postoperative Analgesia

Keywords

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Epidural analgesia continuous wound infusion ropivacaine total abdominal hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural analgesia

Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type OTHER

Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly

Continuous wound infusion

The continuous wound infusion consists of 0.376% ropivacaine infusion in the wound area at a rate 2 ml per hour.

Group Type EXPERIMENTAL

Continuous wound infusion

Intervention Type OTHER

Continuous wound infusion via catheter

Interventions

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Epidural analgesia

Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly

Intervention Type OTHER

Continuous wound infusion

Continuous wound infusion via catheter

Intervention Type OTHER

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

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Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Argyro Fassoulaki

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Argyro Fassoulaki, MD,PhD, DEAA

Role: PRINCIPAL_INVESTIGATOR

University of Athens

Locations

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Aretaieio Hospital

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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M-20/23-02-2010

Identifier Type: -

Identifier Source: org_study_id