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

This study is currently recruiting participants.

Verified by Hvidovre University Hospital, October 2008

First Received: October 7, 2008 Last Updated: October 16, 2008 History of Changes

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00769054

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 IV

MedlinePlus related topics: Pelvic Support Problems

Drug Information available for: Ropivacaine Ropivacaine monohydrochloride Ropivacaine Hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

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
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Local Infiltration with Ropivacaine	Drug: Ropivacaine Local Infiltration Analgesia with 1 % Ropivacaine
2: Placebo Comparator 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

Contacts

Contact: Billy B Kristensen, MD

+45 36 32 25 27

billy.kristensen@hvh.regionh.dk

Locations

Denmark, Hvidovre
Hvidovre University Hospital	Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Billy B Kristensen, MD + 45 36 32 25 27 billy.kristensen@hvh.regionh.dk
Principal Investigator: Billy B Kristensen, MD

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator:

Billy B Kristensen, MD

Hvidovre University Hospital

More Information

No publications provided

Responsible Party:	Hvidovre University Hospital ( Billy B Kristensen )
Study ID Numbers:	H-C-2008-035
Study First Received:	October 7, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00769054 History of Changes
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:

Postoperative pain
PONV

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Uterine Prolapse
Gastrointestinal Diseases
Ropivacaine
Central Nervous System Depressants
Anesthetics
Uterine Diseases
Pain
Intestinal Diseases

Prolapse
Rectal Diseases
Anesthetics, Local
Genital Diseases, Female
Digestive System Diseases
Peripheral Nervous System Agents
Pain, Postoperative
Rectal Prolapse

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Uterine Prolapse
Gastrointestinal Diseases
Ropivacaine
Physiological Effects of Drugs
Central Nervous System Depressants
Uterine Diseases
Anesthetics
Intestinal Diseases
Prolapse

Rectal Diseases
Pharmacologic Actions
Anesthetics, Local
Genital Diseases, Female
Digestive System Diseases
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Rectal Prolapse

ClinicalTrials.gov processed this record on May 07, 2009