Back to resultsTopic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration
Primary Purpose
Pain, Abortion, Spontaneous
Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Lidocain topical + paracervical blockade
Lidocaine topical
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
Eligibility Criteria
Inclusion Criteria:
- Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).
Exclusion Criteria:
- Allergy to lidocain
Sites / Locations
- Saint Thomas H
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lidocaine + paracervical blockade
Lidocaine
Arm Description
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied.
Outcomes
Primary Outcome Measures
Global evaluation of pain
Visible scale of pain evaluation
Secondary Outcome Measures
Adverse reaction
Presence of adverse effects to the drug used (lidocaine gel)
Full Information
NCT ID
NCT04791020
First Posted
March 5, 2021
Last Updated
October 4, 2021
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT04791020
Brief Title
Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration
Official Title
Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. lidocaine gel alone in the management of pain during endouterine manual aspiration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Abortion, Spontaneous
Keywords
Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine + paracervical blockade
Arm Type
Active Comparator
Arm Description
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied.
Intervention Type
Drug
Intervention Name(s)
Lidocain topical + paracervical blockade
Intervention Description
5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade
Intervention Type
Drug
Intervention Name(s)
Lidocaine topical
Intervention Description
5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.
Primary Outcome Measure Information:
Title
Global evaluation of pain
Description
Visible scale of pain evaluation
Time Frame
5 minutes post procedure
Secondary Outcome Measure Information:
Title
Adverse reaction
Description
Presence of adverse effects to the drug used (lidocaine gel)
Time Frame
5 minutes post procedure
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).
Exclusion Criteria:
Allergy to lidocain
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration
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