Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration

Overview

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

Full Title of Study: “Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2021

Interventions

  • Drug: Lidocain topical + paracervical blockade
    • 5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade
  • Drug: Lidocaine topical
    • 5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.

Arms, Groups and Cohorts

  • Active Comparator: Lidocaine + paracervical blockade
    • 5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.
  • Experimental: Lidocaine
    • 5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied.

Clinical Trial Outcome Measures

Primary Measures

  • Global evaluation of pain
    • Time Frame: 5 minutes post procedure
    • Visible scale of pain evaluation

Secondary Measures

  • Adverse reaction
    • Time Frame: 5 minutes post procedure
    • Presence of adverse effects to the drug used (lidocaine gel)

Participating in This Clinical Trial

Inclusion Criteria

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

  • Allergy to lidocain

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saint Thomas Hospital, Panama
  • Provider of Information About this Clinical Study
    • Principal Investigator: Osvaldo A. Reyes T., Coordinator of research – Saint Thomas Hospital, Panama

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