ClinicalTrials.gg
Sign In
CompletedNCT03397082Updated Dec 11, 2018

Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration

An interventional study of Lidocaine gel and Placebo in Pain, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Aug 2014, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Sex
Female
01

Study summary

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

02

Conditions studied

  • Pain

Browse trials for

Keywords

  • Endouterine manual aspiration
  • Paracervical blockade
  • Lidocaine gel
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 86 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Allergy to lidocaine.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Lidocaine + Paracervical blockade

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

    Drug: Lidocaine gel

  • Placebo comparator
    Placebo + paracervical blockade

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

    Drug: Placebo

Interventions

  • DrugLidocaine gel

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Global evaluation of pain

    Visual scale of pain evaluation

    Time frame: 5 minutes post procedure

Secondary outcomes

  1. Adverse reaction

    Presence of adverse effects to the drug used (lidocaine gel)

    Time frame: 5 minutes post procedure

07

Study locations

1 site
  • Saint Thomas Maternity Hospital
    Panama, Panama
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2014 to primary completion in Sep 2014, 1 month.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 1 month is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2018
First posted
Jan 11, 2018
StartActual
Aug 1, 2014
Primary completionActual
Sep 30, 2014
CompletionActual
Dec 1, 2014
Last update
Dec 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03397082
Lead sponsor
Saint Thomas Hospital, Panama
Responsible party
Osvaldo A. Reyes T. (Coordinator Research Department, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Jan 11, 2018
Start date
Aug 1, 2014
Primary completion
Sep 30, 2014
Completion
Dec 1, 2014
Last update
Dec 11, 2018

Study contacts

Osvaldo Reyes, Md
study director · Saint Thomas Maternity Hospital
Ariel Veces
principal investigator · Saint Thomas Maternity Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lidocaine

Other studies in this condition

Pain →

Other studies from this sponsor

Saint Thomas Hospital, Panama

Start the discussion