Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study

Vaginal Prolapse Clinical Trial

Official title:

Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769054
• Other study ID #: H-C-2008-035
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2008
• Last updated: July 8, 2010
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: October 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 or placebo in patients undergoing repair of posterior vaginal wall prolapse.

The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• eligible for elective repair of posterior vaginal wall prolapse

• 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

• Prolapse
• Vaginal Prolapse

Intervention

Drug:
• Ropivacaine
Local Infiltration Analgesia with 1 % Ropivacaine
• 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 during rest, coughing and ambulation		½, 1, 2, 4, 8, 12 and 24 h postoperatively	No
Secondary	Postoperative Nausea and Vomitus		½, 1, 2, 4, 8, 12 and 24 h postoperatively	No