Local Infiltration Analgesia With Ropivacaine Versus Plac... | NCT00891540

Studies
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

NCT00891540

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

90Estimated

Phase

Phase 4

Conditions

Pain, Postoperative
Postoperative Nausea and Vomiting
Cesarean Section

Interventions

Ropivacaine
Ropivacaine
placebo

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

Apr 2009

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

Jul 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 30, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

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

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Local infiltration with Ropivacaine	Drug: Ropivacaine
2	Active Comparator	Local infiltration with Ropivacaine	Drug: Ropivacaine
3	Placebo Comparator	Local infiltration with NaCl	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	Ropivacaine 0.5%	1
Ropivacaine

Measure	Description	Time Frame
Postoperative pain		24 hours

Measure	Description	Time Frame
Postoperative nausea and vomiting (PONV)		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

eligible for elective caesarean section
able to speak and understand Danish
able to give informed consent

Exclusion Criteria:

alcohol or medical abuse
allergies to local anesthetics
age < 18 years
intolerance to opioids

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

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