Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

October 8, 2013 updated by: Arvi Yli-Hankala, Tampere University Hospital

Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions

Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

225

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, 33521
        • 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

Sampling Method

Probability Sample

Study Population

Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.

Description

Inclusion Criteria:

  • Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
  • Age 18-69 years
  • Gender: female
  • ASA status 1-3

Exclusion Criteria:

  • Body Mass Index over 35
  • Diabetes mellitus
  • Liver disease
  • Preoperative use of opioids

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hysterectomy
Patient who previously underwent vaginal or laparoscopic hysterectomy
Procedure: vaginal or laparoscopic hysterectomy
vaginal hysterectomy or laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of persistent postsurgical pain as measured at 6 months after surgery.
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity, location, characteristics of persistent postsurgical pain.
Time Frame: five years
five years
Effect of postsurgical pain on activity, sleep.
Time Frame: five years
five years

Collaborators and Investigators

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

Sponsor

Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2009

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (ESTIMATE)

February 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R08031M 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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