Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)
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|