Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Postoperative Pain After Vaginal or Laparoscopic Hysterectomy: a Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442961
• Other study ID #: R09003
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: April 9, 2013
• Start date: January 2009
• Est. completion date: March 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• laparoscopy, laparoscopic hysterectomy
laparoscopic hysterectomy
• vaginal : vaginal hysterectomy
Vaginal 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	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	20 hours	No
Secondary	NRS (numeral rating scale) of pain	NRS is evaluated frequently during the study period.	20 hours	No