PainNCT03397082
Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration
A study testing Lidocaine gel in people with Pain, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade 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
- What is being tested?
- Lidocaine gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 sitePanama
- Study dates
- 1 Aug 2014to 1 Dec 2014
- 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 lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topic Use of Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Control During Endouterine Manual Aspiration: A Randomized Controlled Trial
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade alone in the management of pain during endouterine manual aspiration.
- Conditions
- Pain
- Being tested
- Lidocaine gel, Placebo
- Keywords
- Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine gelDrug
5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade.
PlaceboDrug
5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine + Paracervical blockade | Experimental | 5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade. Receives: Drug: Lidocaine gel |
| Placebo + paracervical blockade | Placebo comparator | 5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global evaluation of pain
Visual 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.
- First posted11 Jan 2018
- Study start1 Aug 2014
- Primary completion30 Sep 2014
- Study completion1 Dec 2014
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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, Md, Study director, Saint Thomas Maternity HospitalAriel Veces, Principal investigator, Saint Thomas Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397082
- Sponsor's protocol ID
- Mhst2014-13
- Status last verified
- Dec 2018
- First submitted
- 2 Jan 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topic Use of Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Control During Endouterine Manual Aspiration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03397082
- Acronym / sponsor ID
- Mhst2014-13
- Conditions
- Pain
- Keywords
- Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 11 Jan 2018 (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. Paracervical blockade 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 | Experimental | Drug: Lidocaine gel5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade. |
| Placebo + paracervical blockade | Placebo comparator | Drug: Placebo5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY). |
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 lidocaine.
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 |
|---|---|---|
| Lidocaine gel5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade. | Drug | Lidocaine + Paracervical blockade |
| Placebo5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade. | Drug | Placebo + paracervical blockade |
Primary outcome
Global evaluation of pain
Time frame: 5 minutes post procedure
Visual 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 11 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Osvaldo Reyes, Md study director
Saint Thomas Maternity Hospital
Ariel Veces principal investigator
Saint Thomas Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine gel in people with Pain, 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 11 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
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 11 Dec 2018; AzTrials last refreshed its copy on 2 Nov 2026.