Clinical Analysis of Pain After Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01706549
First received: October 10, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.

Condition
Posthysterectomy Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Type of chronic pain after hysterectomy [ Time Frame: 1-3 years after hysterectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life after hysterectomy [ Time Frame: 1-3 years after hysterectomy ] [ Designated as safety issue: No ]
  • Is the pain postsurgical in nature [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Posthysterectomy pain
Observational study on posthysterectomy pain

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706549

Locations
Finland
Tampere University Hospital
Tampere, Finland, 33200
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01706549     History of Changes
Other Study ID Numbers: R11190
Study First Received: October 10, 2012
Last Updated: March 6, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
Chronic pain
Hysterectomy
Quality of life

ClinicalTrials.gov processed this record on September 30, 2014