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Completed

NCT Number: NCT01916473

Epidural Versus Continuous Wound Ropivacaine Infusion Analgesia

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

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Key information

Conditions

Postoperative Analgesia

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieio Hospital

Athens, 11528, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Epidural analgesia

Other

Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly

Continuous wound infusion

Other

Continuous wound infusion via catheter

Primary outcomes

  1. Postoperative morphine consumption

    Time frame: 2 hours postoperatively

  2. Postoperative morphine consumption

    Time frame: 4 hours postoperatively

  3. Postoperative morphine consumption

    Time frame: 8 hours postoperatively

  4. Postoperative morphine consumption

    Time frame: 24 hours postoperatively

  5. Postoperative morphine consumption

    Time frame: 48 hours postoperatively

  6. Postoperative morphine consumption

    Time frame: 72 hours postoperatively

  7. Postoperative morphine consumption

    Time frame: 3 months postoperatively

  8. Postoperative morphine consumption

    Time frame: 6 months postoperatively

Secondary outcomes

  1. pain scores

    Time frame: 2 hours postoperatively

  2. pain scores

    Time frame: 4 hours postoperatively

  3. pain scores

    Time frame: 8 hours postoperatively

  4. pain scores

    Time frame: 24 hours postoperatively

  5. pain scores

    Time frame: 48 hours postoperatively

  6. pain scores

    Time frame: 72 hours postoperatively

  7. pain scores

    Time frame: 3 months postoperatively

  8. pain scores

    Time frame: 6 months postoperatively

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2013
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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