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Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
laparoscopy, laparoscopic hysterectomy
vaginal : vaginal hysterectomy
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring pain, postoperative, hysterectomy, vaginal, surgery, gynecological

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopy

vaginal

Arm Description

Intervention: Procedure: laparoscopy

Intervention: Procedure: vaginal

Outcomes

Primary Outcome Measures

Postoperative consumption of an opioid (oxycodone)
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
NRS is evaluated frequently during the study period.

Full Information

First Posted
September 19, 2011
Last Updated
April 9, 2013
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01442961
Brief Title
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain
Official Title
Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain, postoperative, hysterectomy, vaginal, surgery, gynecological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopy
Arm Type
Active Comparator
Arm Description
Intervention: Procedure: laparoscopy
Arm Title
vaginal
Arm Type
Active Comparator
Arm Description
Intervention: Procedure: vaginal
Intervention Type
Procedure
Intervention Name(s)
laparoscopy, laparoscopic hysterectomy
Intervention Description
laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
vaginal : vaginal hysterectomy
Intervention Description
Vaginal hysterectomy
Primary Outcome Measure Information:
Title
Postoperative consumption of an opioid (oxycodone)
Description
the consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump
Time Frame
20 hours
Secondary Outcome Measure Information:
Title
NRS (numeral rating scale) of pain
Description
NRS is evaluated frequently during the study period.
Time Frame
20 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland

12. IPD Sharing Statement

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Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

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