4% Intrauterine Lidocaine Infusion for Pain Management in... | NCT00121329

Studies
4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions

NCT00121329

Sponsor

Oregon Health and Science University

Status

Completed

Last Update Posted

Jul 21, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Pain

Interventions

Intrauterine lidocaine infusion 4%

Countries

United States

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

Jul 2005

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

Not provided

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Jul 13, 2005

First Submission Date that Met QC Criteria

Jul 19, 2005

First Posted Date

Jul 21, 2005Estimated

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 19, 2005

Last Update Posted Date

Jul 21, 2005Estimated

Description Module

Brief Summary

Recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine) to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy and office hysteroscopy. Local anesthetic injected into the uterine cavity has been demonstrated effective in some studies at decreasing patient pain associated with these intrauterine procedures at an anesthetic concentration of at least 2%. Based on this evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain during first trimester abortions.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Intrauterine lidocaine infusion 4%	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS scores during cervical dilation and uterine aspiration

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction, symptoms, lidocaine levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
Good general health
English speaking
Confirmation of gestational age by ultrasound
Body weight > 100 lbs.
Pregnancy < 11 weeks

Accepts Healthy Volunteers

Yes

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
Alison B Edelman, MD, MPH	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood of the Columbia Willamette		Portland	Oregon	97206	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

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

Browse Leaves

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Browse Branches

Not provided