PainNCT04791020

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

A study testing Lidocain topical + paracervical blockade and Lidocaine topical in people with Pain and Abortion, Spontaneous, run by Saint Thomas Hospital, Panama at 1 site in Panama.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Any age, women only
Conditions the study is for: Pain, Abortion, Spontaneous
What is being tested?: Lidocain topical + paracervical blockade and Lidocaine topical
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 sitePanama
Study dates: 8 Mar 2021to 30 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Allergy to lidocain

Trial locations and contacts

1 site in 1 country.

Panama1 site

Saint Thomas H
Panama City

Other trials in Panama

About this study

Official title: Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration

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

Conditions: Pain, Abortion, Spontaneous
Being tested: Lidocain topical + paracervical blockade, Lidocaine topical
Keywords: Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
Medical subject headings: Pain, Abortion, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04791020
Study group	Role	What they receive
Lidocaine + paracervical blockade	Active comparator	5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade. Receives: Drug: Lidocain topical + paracervical blockade
Lidocaine	Experimental	5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied. Receives: Drug: Lidocaine topical

What is being measured

The primary outcome is the main question the study is designed to answer.

Global evaluation of pain
Visible scale of pain evaluation
Measured: 5 minutes post procedure

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 202130 Jun 2021

First posted10 Mar 2021
Study start8 Mar 2021
Primary completion31 May 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04791020
Sponsor's protocol ID: 2020-555
Status last verified: Oct 2021
First submitted: 5 Mar 2021
Last updated: 6 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration
ClinicalTrials.gov ID: NCT04791020
Acronym / sponsor ID: 2020-555
Conditions: Pain, Abortion, Spontaneous
Keywords: Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Saint Thomas Hospital, PanamaUniversity, hospital or other
Study start: 8 Mar 2021 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 10 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lidocaine + paracervical blockade	Active comparator	Drug: Lidocain topical + paracervical blockade5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade.
Lidocaine	Experimental	Drug: Lidocaine topical5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Allergy to lidocain

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lidocain topical + paracervical blockade5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade	Drug	Lidocaine + paracervical blockade
Lidocaine topical5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.	Drug	Lidocaine

Primary outcome

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

1 secondary outcome

Adverse reaction
Time frame: 5 minutes post procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
Individual participant dataSharing planned: No

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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lidocain topical + paracervical blockade and Lidocaine topical in people with Pain and Abortion, Spontaneous, run by Saint Thomas Hospital, Panama at 1 site in Panama.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global evaluation of pain (time frame: 5 minutes post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04791020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.