Clinical Analysis of Pain After Hysterectomy

December 23, 2016 updated by: Tampere University Hospital

Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:

  1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.
  2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.
  3. to reveal the impact of pain on quality of life.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All patients were treated in Pirkanmaa District Hospital and the anesthesia was either propofol-infusion or sevoflurane gas with remifentanil-infusion.

6months after the surgery, questionnaires about pelvic pain were sent to the patients. Patients still having pain at that time, were invited for detailed sensory and gynecological examinations.

Study Type

Observational

Enrollment (Actual)

16

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, 33200
        • 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

Non-Probability Sample

Study Population

Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6 months after surgery. The patients are invited to participate in this study, if they have participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative pain" by Yli-Hankala and Pokkinen.

Description

Inclusion Criteria:

  • hysterectomy 1-3 years previously
  • suffering from pain 6months postsurgically

Exclusion Criteria:

-

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Posthysterectomy pain
Observational study on posthysterectomy pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of Chronic Pain After Hysterectomy
Time Frame: 1-3 years after hysterectomy
Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.
1-3 years after hysterectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life After Hysterectomy
Time Frame: 1-3 years after hysterectomy
Quality of life as measured by the SF-36, which consists of 8 scales.
1-3 years after hysterectomy
Is the Pain Due to Hysterectomy?
Time Frame: 1-3 years
Number of patients having posthysterectomy pain versus other pain
1-3 years

Collaborators and Investigators

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

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Satu Pokkinen, MD, Tampere University Hospital
  • Study Director: Maija-Liisa Kalliomäki, MD, PhD, Tampere University Hospital
  • Principal Investigator: Kari Nieminen, MD, Doc, 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

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R11190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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