ContraceptionNCT02651207
Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion
An observational study of Contraception, run by Tayside Medical Science Centre.
Trial summary
Study to look at the acceptability of local anaesthetic spray versus injection, prior to contraceptive implant insertion Read more about this study
- Who is it for?
- Ages 13 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2016
- Phase
- Observational
- 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 13 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patient who choose to use the contraceptive implant as a method of contraception and who are deemed medically eligible for the method with no medical contrainidications
Who may be able to join
- Patient has chosen to use the implant as a method of contraception
- Patients will be assessed for medical eligibility for the contraceptive implant have no contraindications to either the implant, lidocaine or the ethyl chloride spray. However, if they have a known sensitivity to either the spray or the lidocaine ejection, they will be offered the other.
- Age between 13 and 55
- Has capacity to consent
- Has read the information sheet and consents to the study
- This will be offered for insertions of implant only i.e. not implant removals
Who cannot join
- Has a contraindication to have a contraceptive implant
- Doesn't wish to have a implant
- Allergy to either the implant, the lidocaine, the ethyl chloride or any of the incipient ingredients. Although patients will be given the option, if they have an allergy/contraindication to one of the products, they will be offered the other
- Is under 13 or over 55
About this study
Official title: Study Looking at Acceptability of Using Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion
Study to look at the acceptability of local anaesthetic spray versus injection, prior to contraceptive implant insertion
Read the detailed description
Currently, patients undergoing contraceptive implant insertion are offered local anaesthetic with an injection before insertion. This study aims to look at whether patients find using the local anaesthetic spray more acceptable or equally acceptable to using local anaesthetic injection. Both are currently licensed products for use as skin anaesthesia but the spray is potentially quicker and involves less injections. Some areas of sexual health are already offering this option but there isn't much evidence as to which patients find more acceptable.
Patients in this study will be given a choice of anaesthetic asked to complete a short questionnaire, giving a pain score , on the pain rating scale of 0 to 10, ( being no pain to 10 being extremely painful. ) In addition, they will be asked to give the reasons for their choice. The questionnaire will be anonymous.
Average pain scores will be calculated between in group and compared.
- Conditions
- Contraception
- Being tested
- Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implantOther
| Study group | Role | What they receive |
|---|---|---|
| local anaesthetic spray group | women will either chose the above, ethyl chloride spray prior to having their contraceptive implant fitted or the below injection. This comes in a canister and a maximum of 5 spray for 5 seconds will be applied topically to the skin at the site of the contraceptive implant insertion Receives: Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant | |
| local anaesthetic injection group | women will either chose ethyl chloride spray prior to having their contraceptive implant fitted or the injection, subcutaneous 1% lidocaine, usually a dose of about 1-2 mls to the area skin where the contraceptive implant is to be inserted. Receives: Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion
Questionnaire based study looking at pain scores on the numeric pain rating scale 0 to 10, 0 being no pain to 10 being extremely painful
Measured: one year
Secondary outcomes (1)
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion
Questionnaire looking at the reasons why women chose to use the injection or the spray
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: decided not to do study. This will be run as a service evaluation instead
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tayside Medical Science Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651207
- Sponsor's protocol ID
- 2015OB09
- Status last verified
- Feb 2017
- First submitted
- 7 Jan 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Looking at Acceptability of Using Ethyl Chloride Spray Versus Subcutaneous Lidocaine Anaesthetic Prior to Contraceptive Implant Insertion
- ClinicalTrials.gov ID
- NCT02651207
- Acronym / sponsor ID
- 2015OB09
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: decided not to do study. This will be run as a service evaluation instead
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tayside Medical Science CentreUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
Study to look at the acceptability of local anaesthetic spray versus injection, prior to contraceptive implant insertion
Detailed description
Currently, patients undergoing contraceptive implant insertion are offered local anaesthetic with an injection before insertion. This study aims to look at whether patients find using the local anaesthetic spray more acceptable or equally acceptable to using local anaesthetic injection. Both are currently licensed products for use as skin anaesthesia but the spray is potentially quicker and involves less injections. Some areas of sexual health are already offering this option but there isn't much evidence as to which patients find more acceptable.
Patients in this study will be given a choice of anaesthetic asked to complete a short questionnaire, giving a pain score , on the pain rating scale of 0 to 10, ( being no pain to 10 being extremely painful. ) In addition, they will be asked to give the reasons for their choice. The questionnaire will be anonymous.
Average pain scores will be calculated between in group and compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anaesthetic spray group | – | Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implantwomen will either chose the above, ethyl chloride spray prior to having their contraceptive implant fitted or the below injection. This comes in a canister and a maximum of 5 spray for 5 seconds will be applied topically to the skin at the site of the contraceptive implant insertion |
| local anaesthetic injection group | – | Other: Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implantwomen will either chose ethyl chloride spray prior to having their contraceptive implant fitted or the injection, subcutaneous 1% lidocaine, usually a dose of about 1-2 mls to the area skin where the contraceptive implant is to be inserted. |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patient who choose to use the contraceptive implant as a method of contraception and who are deemed medically eligible for the method with no medical contrainidications
Key inclusion criteria (6 listed)
- Patient has chosen to use the implant as a method of contraception
- Patients will be assessed for medical eligibility for the contraceptive implant have no contraindications to either the implant, lidocaine or the ethyl chloride spray. However, if they have a known sensitivity to either the spray or the lidocaine ejection, they will be offered the other.
- Age between 13 and 55
- Has capacity to consent
- Has read the information sheet and consents to the study
Key exclusion criteria (4 listed)
- Has a contraindication to have a contraceptive implant
- Doesn't wish to have a implant
- Allergy to either the implant, the lidocaine, the ethyl chloride or any of the incipient ingredients. Although patients will be given the option, if they have an allergy/contraindication to one of the products, they will be offered the other
- Is under 13 or over 55
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 |
|---|---|---|
| Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant | Other | local anaesthetic injection group, local anaesthetic spray group |
Primary outcome
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion
Time frame: one year
Questionnaire based study looking at pain scores on the numeric pain rating scale 0 to 10, 0 being no pain to 10 being extremely painful
1 secondary outcome
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Tayside Medical Science Centre.
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 4 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: withdrawn, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
acceptability of using ethyl chloride spray versus subcutaneous lidocaine anaesthetic prior to contraceptive implant insertion (time frame: one year). 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 20 Feb 2017.