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

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00769054
First received: October 7, 2008
Last updated: July 8, 2010
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Vaginal Prolapse
 Drug: Ropivacaine
Drug: Isotonic NaCl
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative Pain during rest, coughing and ambulation [ Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative Nausea and Vomitus [ Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769054

Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Billy B Kristensen, MD Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Billy B Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00769054     History of Changes
Other Study ID Numbers: H-C-2008-035
Study First Received: October 7, 2008
Last Updated: July 8, 2010
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Postoperative pain
PONV

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse
Ropivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013