NCT04791020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

March 5, 2021

Last Update Submit

October 4, 2021

Conditions

PainAbortion, Spontaneous

Keywords

Endouterine manual aspirationParacervical blockadeLidocaine gel

Outcome Measures

Primary Outcomes (1)

  • Global evaluation of pain

    Visible scale of pain evaluation

    5 minutes post procedure

Secondary Outcomes (1)

  • Adverse reaction

    5 minutes post procedure

Study Arms (2)

Lidocaine + paracervical blockade

ACTIVE COMPARATOR

5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.

Drug: Lidocain topical + paracervical blockade

Lidocaine

EXPERIMENTAL

5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied.

Drug: Lidocaine topical

Interventions

Lidocain topical + paracervical blockadeDRUG

5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade

Lidocaine + paracervical blockade
Lidocaine topicalDRUG

5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.

Lidocaine

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to lidocain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

PainAbortion, Spontaneous

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of research

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 10, 2021

Study Start

March 8, 2021

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

October 6, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)