NCT01916473

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

July 15, 2013

Last Update Submit

August 1, 2013

Conditions

Postoperative Analgesia

Keywords

Epidural analgesiacontinuous wound infusionropivacainetotal abdominal hysterectomy

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Epidural analgesia

ACTIVE COMPARATOR

Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly

Other: Epidural analgesia

Continuous wound infusion

EXPERIMENTAL

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

Interventions

Epidural analgesiaOTHER

Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly

Epidural analgesia
Continuous wound infusionOTHER

Continuous wound infusion via catheter

Continuous wound infusion

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients ASA I-II scheduled for abdominal hysterectomy or myomectomy -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio Hospital

Athens, 11528, Greece

Location

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Argyro Fassoulaki, MD,PhD, DEAA

    University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

July 15, 2013

First Posted

August 5, 2013

Study Start

April 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

GR(1)