Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

August 1, 2013 updated by: Argyro Fassoulaki, University of Athens

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Aretaieio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Epidural analgesia
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
Other: Epidural analgesia
Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
Experimental: Continuous wound infusion
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
Continuous wound infusion via catheter

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Principal Investigator: Argyro Fassoulaki, MD,PhD, DEAA, University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

August 5, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20/23-02-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Analgesia

Clinical Trials on Epidural analgesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe