Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration (Ametop)

December 10, 2013 updated by: University of British Columbia

The Efficacy of Topical Amethocaine Gel in Reducing the Pain of Local Anesthetic Infiltration Prior to Neuraxial Anesthesia in Non-labouring Pregnant Women: A Randomized Controlled Trial

Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to randomize 70 women to have either the numbing cream or a similar looking moisturizing cream placed on their lower back before their anesthetic. They will rate the discomfort of the freezing injection allowing us to compare the two groups and determine if the numbing cream is effective.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 1

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's 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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any pregnant subject undergoing an elective procedure under neuraxial anesthesia.

Exclusion Criteria:

  • Any contraindication to neuraxial anesthesia
  • Subjects in labour

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: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ametop cream
Drug: Ametop cream
Other Names:
  • amethocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Within 5 minutes of spinal
Patient will be asked to give a pain score
Within 5 minutes of spinal

Collaborators and Investigators

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

Sponsor

University of British Columbia

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

May 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (ESTIMATE)

May 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-00771

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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