Lidocaine ToxicityNCT05241496
Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion
A study testing The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration in people with Lidocaine Toxicity, run by Marina Ramsis Aziz Ghaly at 1 site in Egypt.
Trial summary
The intrauterine contraceptive device (IUD) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper IUD (a plastic T-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lidocaine Toxicity
- What is being tested?
- The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 10 Oct 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -Multiparous women in 3rd to 5th day of menstrual cycle 2- Women who were 6 weeks postpartum or if recently pregnant. 3- Accept to participate and provide consent
Who cannot join
- • A contraindication for IUD use such as a gynecological malignancy , sexually transmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.
- Suspicion of pregnancy .
- Allergy to lidocaine or ibuprofen .
- Copper allergy .
- Any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis , and submucous myoma.
- A psychological or neurological disorder associated with altered pain sensation.
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- MIRENA insertion.
- Nulliparity.
- History of failed intrauterine device insertion (uterine perforation, acute expulsion).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinSHAMS UNIV
Cairo, 11531
Marina Rm Ghaly, doctor, +20 127 186 9711, dr.marina_ramsis@med.asu.edu.eg
doctor
About this study
Official title: Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion (A Randomized Controlled Trial)
The intrauterine contraceptive device (IUD) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper IUD (a plastic T-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due to its long-term effectiveness, safety and affordability .
Inconsistent use and discontinuation of contraceptives are major causes of unintended pregnancy . The failure rate of the patch or ring is 20 times higher than that of long acting reversible contraceptives (LARCs) . Increasing acceptability and use of LARC methods like the intrauterine device (IUD) is an important strategy to reduce the risk of unintended pregnancy
Read the detailed description
The aim of this study is to This study is designed to compare between lidocaine spray 10% and oral ibuprofen as an adequate method for decreasing pain during copper intrauterine contraceptive device insertion .
Research question:
Which of both drugs ( local lidocaine spray 10% or oral ibuprofen tab.) is more effective in decreasing pain during IUD insertion ? Research Hypothesis In this current study, we hypothesize that using of local cervical lidocaine spray 10% prior to IUD insertion will decrease the pain more effectively than ibuprofen tablet 400 mg.
- Conditions
- Lidocaine Toxicity
- Being tested
- The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The spray form may provide easy application and better patient acceptance than other forms of lidocaine administrationDiagnostic test
Lidocaine in spray form is a simple and convenient local anaesthetic with minimal adverse effects and is often used in dentistry for oral mucosal anaesthesia during minor surgical interventions. The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration. Lidocaine acts by stabilization of the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action (Hüseyin Aksoy et al. ,2016 ) .
| Study group | Role | What they receive |
|---|---|---|
| Marina Ramsis | Experimental | In the other group, 70 women will be randomly assigned for ibuprofen; participants will take 1 tablet (400mg) immediately \& clinicians will wait at least 45 minutes before inserting the copper IUD Receives: Diagnostic Test: The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain score [ Time Frame: immediately after IUD insertion ]
The visual analog scale (VAS ) pain score reported by participants immediately after IUD insertion .Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 for no pain, 1-3 for mild pain, 4-6 for average pain, and 7-9 for severe pain and 10 for extremely severe pain an individual can experience .
A research assistant standing beside the woman will hold the VAS sheet for the participant to select the point that corresponds to the level of pain she will experience after IUD insertion .
Measured: immediately after IUD insertion
Secondary outcomes (1)
Immediate complications related to IUD insertion [ Time Frame: one day after insertion]:
Immediate complications related to IUD insertion [ Time Frame: one day after insertion]:
The immediate complications related to IUD insertion such as :
- Failure of insertion .
- Vasovagal reaction .
- The number of women who will need analgesics after insertion.
Measured: one day after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Dec 2021
- Primary completion14 Dec 2022 (estimated)
- Study completion10 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lidocaine ToxicityStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marina Ramsis Aziz Ghaly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marina Ramsis Aziz Ghaly, Ain Shams University
- Investigators
- Alhassan M Khedr, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241496
- Sponsor's protocol ID
- AinShams univ
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
PubMed 25759418
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Spray 10% Versus Oral Ibuprofen Tablets in Pain Control During Copper Intrauterine Device Insertion (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05241496
- Acronym / sponsor ID
- AinShams univ
- Conditions
- Lidocaine Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Marina Ramsis Aziz GhalyUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 14 Dec 2022 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 15 Feb 2022 (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 intrauterine contraceptive device (IUD) is the most commonly used form of reversible contraception worldwide; the predominant type of product, the copper IUD (a plastic T-shaped device with copper affixed to it) was developed over 30 years ago and has become the standard bearer for intrauterine contraception, due to its long-term effectiveness, safety and affordability .
Inconsistent use and discontinuation of contraceptives are major causes of unintended pregnancy . The failure rate of the patch or ring is 20 times higher than that of long acting reversible contraceptives (LARCs) . Increasing acceptability and use of LARC methods like the intrauterine device (IUD) is an important strategy to reduce the risk of unintended pregnancy
Detailed description
The aim of this study is to This study is designed to compare between lidocaine spray 10% and oral ibuprofen as an adequate method for decreasing pain during copper intrauterine contraceptive device insertion .
Research question:
Which of both drugs ( local lidocaine spray 10% or oral ibuprofen tab.) is more effective in decreasing pain during IUD insertion ? Research Hypothesis In this current study, we hypothesize that using of local cervical lidocaine spray 10% prior to IUD insertion will decrease the pain more effectively than ibuprofen tablet 400 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marina Ramsis | Experimental | Diagnostic Test: The spray form may provide easy application and better patient acceptance than other forms of lidocaine administrationIn the other group, 70 women will be randomly assigned for ibuprofen; participants will take 1 tablet (400mg) immediately \& clinicians will wait at least 45 minutes before inserting the copper IUD |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Multiparous women in 3rd to 5th day of menstrual cycle 2- Women who were 6 weeks postpartum or if recently pregnant. 3- Accept to participate and provide consent
Key exclusion criteria (9 listed)
- • A contraindication for IUD use such as a gynecological malignancy , sexually transmitted diseases, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.
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 |
|---|---|---|
| The spray form may provide easy application and better patient acceptance than other forms of lidocaine administrationLidocaine in spray form is a simple and convenient local anaesthetic with minimal adverse effects and is often used in dentistry for oral mucosal anaesthesia during minor surgical interventions. The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration. Lidocaine acts by stabilization of the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action (Hüseyin Aksoy et al. ,2016 ) . | Diagnostic test | Marina Ramsis |
Primary outcome
Self-reported pain score [ Time Frame: immediately after IUD insertion ]
Time frame: immediately after IUD insertion
The visual analog scale (VAS ) pain score reported by participants immediately after IUD insertion .Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponds to no pain and 10 cm to the worst pain. VAS is rated as 0 for no pain, 1-3 for mild pain, 4-6 for average pain, and 7-9 for severe pain and 10 for extremely severe pain an individual can experience . A research assistant standing beside the woman will hold the VAS sheet for the participant to select the point that corresponds to the level of pain she will experience after IUD insertion .
1 secondary outcome
Immediate complications related to IUD insertion [ Time Frame: one day after insertion]:
Time frame: one day after insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 25759418Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
- 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.
Alhassan M Khedr study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The spray form may provide easy application and better patient acceptance than other forms of lidocaine administration in people with Lidocaine Toxicity, run by Marina Ramsis Aziz Ghaly at 1 site in Egypt.
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 9 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina RM Ghaly, Doctor (+20 127 186 9711, dr.marina_ramsis@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain score [ Time Frame: immediately after IUD insertion ] (time frame: immediately after IUD insertion). 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 NCT05241496, which also lists 1 linked publication.
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 19 Jul 2022.