Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Lidocaine gel

• Registration Number: NCT03397082
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2014-09-30
• Study Completion: 2014-12-01
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-08
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

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

Exclusion Criteria

• Allergy to lidocaine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + paracervical blockade	Placebo	5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY).
Lidocaine + Paracervical blockade	Lidocaine gel	5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.

Primary Outcome Measures

Name	Time	Method
Global evaluation of pain	5 minutes post procedure	Visual scale of pain evaluation

Secondary Outcome Measures

Name	Time	Method
Adverse reaction	5 minutes post procedure	Presence of adverse effects to the drug used (lidocaine gel)

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama