Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 283 for:    Panama

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
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade alone in the management of pain during endouterine manual aspiration.

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine gel Drug: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: Placebo
5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.




Primary Outcome Measures :
  1. Global evaluation of pain [ Time Frame: 5 minutes post procedure ]
    Visual scale of pain evaluation


Secondary Outcome Measures :
  1. Adverse reaction [ Time Frame: 5 minutes post procedure ]
    Presence of adverse effects to the drug used (lidocaine gel)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).

Exclusion Criteria:

  • Allergy to lidocaine.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Layout table for investigator information
Study Director: Osvaldo Reyes, Md Saint Thomas Maternity Hospital
Principal Investigator: Ariel Veces Saint Thomas Maternity Hospital

Layout table for additonal information
Responsible Party: Osvaldo A. Reyes T., Coordinator Research Department, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT03397082     History of Changes
Other Study ID Numbers: Mhst2014-13
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Endouterine manual aspiration
Paracervical blockade
Lidocaine gel
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action