Local Infiltration Analgesia With Ropivacaine in Posterio... | NCT00769054

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

NCT00769054

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jul 9, 2010Estimated

Enrollment

48Estimated

Phase

Phase 4

Conditions

Vaginal Prolapse

Interventions

Ropivacaine
Isotonic NaCl

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2010

Last Update Posted Date

Jul 9, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Local Infiltration with Ropivacaine	Drug: Ropivacaine
2	Placebo Comparator	Local Infiltration with Placebo	Drug: Isotonic NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	Local Infiltration Analgesia with 1 % Ropivacaine	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Pain during rest, coughing and ambulation		½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Postoperative Nausea and Vomitus		½, 1, 2, 4, 8, 12 and 24 h postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Billy B Kristensen, MD	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Copenhagen	Hvidovre	2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D014596	Uterine Prolapse
D010149	Pain, Postoperative
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided