Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

Pain, Postoperative Clinical Trial

Official title:

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768456
• Other study ID #: H-C-2008-030
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2008
• Last updated: June 22, 2011
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2008
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.

The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• eligible for elective vaginal hysterectomy

• able to speak and understand Danish

• able to give informed consent

Exclusion Criteria:

• alcohol or medical abuse

• allergies to local anesthetics

• age < 18 yrs.

• intolerance to opioids

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Ropivacaine 0.5 %
Local Infiltration with Ropivacaine 0.5 %
• Isotonic NaCl
Local Infiltration with NaCl

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain		32 h	No
Secondary	PONV		32 h	No