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Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

This study is currently recruiting participants.
Verified April 2013 by Tampere University Hospital
Sponsor:
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01537731
First received: January 10, 2012
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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

Contacts
Contact: Arvi Yli-Hankala, M.D. +3583116111 arvi-yli.hankala@pshp.fi
Contact: Satu Pokkinen, M.D. +3583116111 satu.pokkinen@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Arvi Yli-Hankala, professor     +3583116111     arvi.yli-hankala@pshp.fi    
Principal Investigator: Arvi Yli-Hankala, M.D.            
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: April 9, 2013
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013