Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration

December 8, 2018 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Topic Use of Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Control During Endouterine Manual Aspiration: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to lidocaine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine + Paracervical blockade
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.
Drug: Lidocaine gel
5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade.
Placebo Comparator: Placebo + paracervical blockade
5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY).
Drug: Placebo
5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global evaluation of pain
Time Frame: 5 minutes post procedure
Visual scale of pain evaluation
5 minutes post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reaction
Time Frame: 5 minutes post procedure
Presence of adverse effects to the drug used (lidocaine gel)
5 minutes post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Investigators

  • Study Director: Osvaldo Reyes, Md, Saint Thomas Maternity Hospital
  • Principal Investigator: Ariel Veces, Saint Thomas Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

September 30, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 8, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mhst2014-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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