Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

April 9, 2013 updated by: Arvi Yli-Hankala, Tampere University Hospital

Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial

The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

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

  • Finland
      • Tampere, Finland
        • Tampere University 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

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 -69 years
  • Gender . female
  • ASA status 1-3
  • Vaginal hysterectomy or laparoscopic hysterectomy

Exclusion Criteria:

  • Body mass Index over 35
  • Diabetes Mellitus
  • Liver disease
  • Allergies to pharmaceuticals used in the Study
  • Present use of opioids
  • Vaginal prolapse

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopy
Intervention: Procedure: laparoscopy
Procedure: laparoscopy, laparoscopic hysterectomy
laparoscopic hysterectomy
Active Comparator: vaginal
Intervention: Procedure: vaginal
Procedure: vaginal : vaginal hysterectomy
Vaginal hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative consumption of an opioid (oxycodone)
Time Frame: 20 hours
the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump
20 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS (numeral rating scale) of pain
Time Frame: 20 hours
NRS is evaluated frequently during the study period.
20 hours

Collaborators and Investigators

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

Sponsor

Tampere University Hospital

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

January 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R09003

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.

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