Pain, AcutePhase 4NCT03111342
Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion
A Phase 4 study testing Anesthesia and Dry-needling in people with Pain, Acute and Anesthesia, Local, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Anesthesia, Local, IUD Insertion Complication
- What is being tested?
- Anesthesia and Dry-needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 31 Aug 2018
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years;
- That were never pregnant before;
- That wants to use LNG-IUD;
- Not pregnant at the time of insertion;
- No haematological disease;
- That do not have signs and / or symptoms of vaginal / cervical infection.
Who cannot join
- Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial
The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.
Read the detailed description
No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.
- Conditions
- Pain, Acute, Anesthesia, Local, IUD Insertion Complication
- Being tested
- Anesthesia, Dry-needling
- Keywords
- Intrauterine contraception, Pain, Anesthesia, LNG-IUD, nulligravida
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnesthesiaDrug
Also called 2% lidocaine without vasoconstritor
A 2% lidocaine without vasoconstrictor injection into the cervix
Dry-needlingProcedure or surgery
A placement of thin needle into the cervix without substance injection
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia | Experimental | A 2% lidocaine without vasoconstrictor injection into the cervix Receives: Drug: Anesthesia |
| Dry-needling | Sham comparator | A placement of thin needle into the cervix without substance injection Receives: Procedure: Dry-needling |
| No intervention | No intervention | No intervention for pain relief prior to LNG-IUS insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain associated with LNG-IUS insertion using VAS
To evaluate pain scores using the visual analog scale (VAS)
Measured: Immediately following LNG-IUS insertion
Secondary outcomes (4)
Pain associated with LNG-IUS insertion using face scale
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Measured: Immediately following LNG-IUS insertion
Pain associated with tenaculum placement using VAS
To evaluate pain scores using the visual analog scale (VAS)
Measured: Immediately following tenaculum placement
Pain associated with tenaculum placement using faces scale
To evaluate pain scores using faces scale of the International Association for the Study of Pain (IASP)
Measured: Immediately following tenaculum placement
Ease of IUS insertion
To evaluate ease of LNG-IUS insertion rated by the provider
Measured: Immediately following LNG-IUS insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Principal investigator, Carolina Sales Vieira, University of Sao Paulo
- Investigators
- Carolina S Vieira, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111342
- Sponsor's protocol ID
- Pain LNG-IUS
- Status last verified
- Jul 2019
- First submitted
- 3 Apr 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD will be collect using Redcap and will be kept in special file until analysis. Then, data will be summarized for analysis.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03111342
- Acronym / sponsor ID
- Pain LNG-IUS
- Conditions
- Pain, Acute, Anesthesia, Local, IUD Insertion Complication
- Keywords
- Intrauterine contraception, Pain, Anesthesia, LNG-IUD, nulligravida
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 12 Apr 2017 (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.
The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.
Detailed description
No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
| Arm | Type | Receives |
|---|---|---|
| Anesthesia | Experimental | Drug: AnesthesiaA 2% lidocaine without vasoconstrictor injection into the cervix |
| Dry-needling | Sham comparator | Procedure: Dry-needlingA placement of thin needle into the cervix without substance injection |
| No intervention | No intervention | –No intervention for pain relief prior to LNG-IUS insertion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 45 years;
- That were never pregnant before;
- That wants to use LNG-IUD;
- Not pregnant at the time of insertion;
- No haematological disease;
Key exclusion criteria (1 listed)
- Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).
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 |
|---|---|---|
| AnesthesiaAlso: 2% lidocaine without vasoconstritorA 2% lidocaine without vasoconstrictor injection into the cervix | Drug | Anesthesia |
| Dry-needlingA placement of thin needle into the cervix without substance injection | Procedure or surgery | Dry-needling |
Primary outcome
Pain associated with LNG-IUS insertion using VAS
Time frame: Immediately following LNG-IUS insertion
To evaluate pain scores using the visual analog scale (VAS)
4 secondary outcomes
Pain associated with LNG-IUS insertion using face scale
Time frame: Immediately following LNG-IUS insertion
Pain associated with tenaculum placement using VAS
Time frame: Immediately following tenaculum placement
Pain associated with tenaculum placement using faces scale
Time frame: Immediately following tenaculum placement
Ease of IUS insertion
Time frame: Immediately following LNG-IUS insertion
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 1 Aug 2019.
- Individual participant dataSharing planned: Undecided. The IPD will be collect using Redcap and will be kept in special file until analysis. Then, data will be summarized for analysis.
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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.
Carolina S Vieira, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anesthesia and Dry-needling in people with Pain, Acute and Anesthesia, Local, run by University of Sao Paulo at 1 site in Brazil.
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 6 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 1 Aug 2019. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain associated with LNG-IUS insertion using VAS (time frame: Immediately following LNG-IUS insertion). 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 1 Aug 2019.