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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01537731
Other study ID # R08031M R09003
Secondary ID
Status Completed
Phase N/A
First received January 10, 2012
Last updated October 8, 2013
Start date April 2009
Est. completion date October 2013

Study information

Verified date October 2013
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 69 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
vaginal or laparoscopic hysterectomy
vaginal hysterectomy or laparoscopic hysterectomy

Locations

Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of persistent postsurgical pain as measured at 6 months after surgery. five years No
Secondary Severity, location, characteristics of persistent postsurgical pain. five years No
Secondary Effect of postsurgical pain on activity, sleep. five years No
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