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Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01442961
First Posted: September 29, 2011
Last Update Posted: April 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
  Purpose
The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.

Condition Intervention
Postoperative Pain Procedure: laparoscopy, laparoscopic hysterectomy Procedure: vaginal : vaginal hysterectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial

Resource links provided by NLM:


Further study details as provided by Arvi Yli-Hankala, Tampere University Hospital:

Primary Outcome Measures:
  • Postoperative consumption of an opioid (oxycodone) [ Time Frame: 20 hours ]
    the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump


Secondary Outcome Measures:
  • NRS (numeral rating scale) of pain [ Time Frame: 20 hours ]
    NRS is evaluated frequently during the study period.


Enrollment: 188
Study Start Date: January 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: laparoscopy
Intervention: Procedure: laparoscopy
Procedure: laparoscopy, laparoscopic hysterectomy
laparoscopic hysterectomy
Active Comparator: vaginal
Intervention: Procedure: vaginal
Procedure: vaginal : vaginal hysterectomy
Vaginal hysterectomy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 -69 years
  • Gender . female
  • ASA status 1-3
  • Vaginal hysterectomy or laparoscopic hysterectomy

Exclusion Criteria:

  • Body mass Index over 35
  • Diabetes Mellitus
  • Liver disease
  • Allergies to pharmaceuticals used in the Study
  • Present use of opioids
  • Vaginal prolapse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442961


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

Responsible Party: Arvi Yli-Hankala, professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01442961     History of Changes
Other Study ID Numbers: R09003
First Submitted: September 19, 2011
First Posted: September 29, 2011
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Arvi Yli-Hankala, Tampere University Hospital:
pain, postoperative
hysterectomy, vaginal
surgery, gynecological

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms