- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04791020
Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration
October 4, 2021 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. lidocaine gel alone in the management of pain during endouterine manual aspiration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
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
-
-
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Panama, Panama
- Saint Thomas H
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-
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 lidocain
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 |
---|---|
Active Comparator: Lidocaine + paracervical blockade
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.
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5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade
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Experimental: Lidocaine
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied.
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5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global evaluation of pain
Time Frame: 5 minutes post procedure
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Visible scale of pain evaluation
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5 minutes post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse reaction
Time Frame: 5 minutes post procedure
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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
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)
March 8, 2021
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
March 5, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
October 4, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Abortion, Spontaneous
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 2020-555
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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