Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration
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|ClinicalTrials.gov Identifier: NCT03397082|
Recruitment Status : Completed
First Posted : January 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Lidocaine gel Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Topic Use of Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Control During Endouterine Manual Aspiration: A Randomized Controlled Trial|
|Actual Study Start Date :||August 1, 2014|
|Actual Primary Completion Date :||September 30, 2014|
|Actual Study Completion Date :||December 1, 2014|
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).
5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.
- Global evaluation of pain [ Time Frame: 5 minutes post procedure ]Visual scale of pain evaluation
- Adverse reaction [ Time Frame: 5 minutes post procedure ]Presence of adverse effects to the drug used (lidocaine gel)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397082
|Saint Thomas Maternity Hospital|
|Study Director:||Osvaldo Reyes, Md||Saint Thomas Maternity Hospital|
|Principal Investigator:||Ariel Veces||Saint Thomas Maternity Hospital|