Labor Analgesia With Ropivacaine and Clonidine | NCT00626977

Studies
Labor Analgesia With Ropivacaine and Clonidine

NCT00626977

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Completed

Last Update Posted

Jul 8, 2015Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Labor Pain

Interventions

ropivacaine
ropivacaine and clonidine

Countries

Brazil

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

Feb 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

May 2000

Primary Completion Date

May 2000Actual

Completion Date

Dec 2001Actual

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 28, 2008

First Posted Date

Feb 29, 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 7, 2015

Last Update Posted Date

Jul 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yara Marcondes Machado Castiglia, MD PhD, UPECLIN HC FM Botucatu UnespPrincipal Investigator

Lead Sponsor

UPECLIN HC FM Botucatu UnespOTHER

Collaborators

Name	Class
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil	OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R		R group:15 mL of 0.125% ropivacaine (18.75 mg)	Drug: ropivacaine
RC		RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine	Drug: ropivacaine and clonidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ropivacaine	Drug	15 ml of ropivacaine 0.125% peridural once	R
ropivacaine and clonidine

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton healthy
Full-term pregnancy
American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

Patients who had received opioids
History of hypersensitivity to local anesthetic or to clonidine
Fetus showed signs of possible intrauterine suffering
Fetus showed signs of possible neurological deficit

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women having requested epidural analgesia for labor and hers newborns

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giane Nakamura, MD PHd	College Study of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
College of Medicine of Botucatu		Botucatu	São Paulo	18618970	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18553032	Derived	Nakamura G, Ganem EM, Modolo NS, Rugolo LM, Castiglia YM. Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial. Sao Paulo Med J. 2008 Mar 6;126(2):102-6. doi: 10.1590/s1516-31802008000200007.

ID	Term
D048949	Labor Pain
D000377	Agnosia

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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