Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01537731
First received: January 10, 2012
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Chronic Postsurgical Pain
Procedure: vaginal or laparoscopic hysterectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Presence of persistent postsurgical pain as measured at 6 months after surgery. [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity, location, characteristics of persistent postsurgical pain. [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Effect of postsurgical pain on activity, sleep. [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: April 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hysterectomy
Patient who previously underwent vaginal or laparoscopic hysterectomy
Procedure: vaginal or laparoscopic hysterectomy
vaginal hysterectomy or laparoscopic hysterectomy

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537731

Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
  More Information

No publications provided

Responsible Party: Arvi Yli-Hankala, professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01537731     History of Changes
Other Study ID Numbers: R08031M R09003
Study First Received: January 10, 2012
Last Updated: October 8, 2013
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on April 17, 2014