Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01442961
First received: September 19, 2011
Last updated: April 9, 2013
Last verified: April 2013
  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: 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 Tampere University Hospital:

Primary Outcome Measures:
  • Postoperative consumption of an opioid (oxycodone) [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 69 Years
Genders 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
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: NCT01442961

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

No publications provided

Responsible Party: Arvi Yli-Hankala, professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01442961     History of Changes
Other Study ID Numbers: R09003
Study First Received: September 19, 2011
Last Updated: April 9, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Tampere University Hospital:
pain, postoperative
hysterectomy, vaginal
surgery, gynecological

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014