NCT03397082

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2014

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

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

January 2, 2018

Last Update Submit

December 8, 2018

Conditions

Pain

Keywords

Endouterine manual aspirationParacervical blockadeLidocaine gel

Outcome Measures

Primary Outcomes (1)

  • Global evaluation of pain

    Visual scale of pain evaluation

    5 minutes post procedure

Secondary Outcomes (1)

  • Adverse reaction

    5 minutes post procedure

Study Arms (2)

Lidocaine + Paracervical blockade

EXPERIMENTAL

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

Drug: Lidocaine gel

Placebo + paracervical blockade

PLACEBO COMPARATOR

5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY).

Drug: Placebo

Interventions

Lidocaine gelDRUG

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

Lidocaine + Paracervical blockade
PlaceboDRUG

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

Placebo + paracervical blockade

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 lidocaine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Osvaldo Reyes, Md

    Saint Thomas Maternity Hospital

    STUDY DIRECTOR

  • Ariel Veces

    Saint Thomas Maternity Hospital

    PRINCIPAL INVESTIGATOR

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 Research Department

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 11, 2018

Study Start

August 1, 2014

Primary Completion

September 30, 2014

Study Completion

December 1, 2014

Last Updated

December 11, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)