Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration

NCT ID: NCT03397082

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2014-12-01

Brief Summary

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To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade alone in the management of pain during endouterine manual aspiration.

Detailed Description

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Conditions

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Pain

Keywords

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Endouterine manual aspiration Paracervical blockade Lidocaine gel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine + Paracervical blockade

5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.

Group Type EXPERIMENTAL

Lidocaine gel

Intervention Type DRUG

5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade.

Placebo + paracervical blockade

5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.

Interventions

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Lidocaine gel

5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade.

Intervention Type DRUG

Placebo

5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).

Exclusion Criteria

* Allergy to lidocaine.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, Md

Role: STUDY_DIRECTOR

Saint Thomas Maternity Hospital

Ariel Veces

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Maternity Hospital

Locations

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Saint Thomas Maternity Hospital

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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Mhst2014-13

Identifier Type: -

Identifier Source: org_study_id