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

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00769054
Collaborator
(none)
48
1
2
12
4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Local Infiltration with Ropivacaine

Drug: Ropivacaine
Local Infiltration Analgesia with 1 % Ropivacaine

Placebo Comparator: 2

Local Infiltration with Placebo

Drug: Isotonic NaCl
Local Infiltration with NaCl

Outcome Measures

Primary Outcome Measures

  1. Postoperative Pain during rest, coughing and ambulation [½, 1, 2, 4, 8, 12 and 24 h postoperatively]

Secondary Outcome Measures

  1. Postoperative Nausea and Vomitus [½, 1, 2, 4, 8, 12 and 24 h postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hvidovre University Hospital Copenhagen Hvidovre Denmark 2650

Sponsors and Collaborators

  • Hvidovre University Hospital

Investigators

  • Principal Investigator: Billy B Kristensen, MD, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00769054
Other Study ID Numbers:
  • H-C-2008-035
First Posted:
Oct 8, 2008
Last Update Posted:
Jul 9, 2010
Last Verified:
Oct 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2010