Pain, ProceduralNCT06344637
Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration
A study testing 10 % lidocaine spray without adrenaline in people with Pain, Procedural and Lidocaine, run by UdonThani Hospital at 1 site in Thailand.
Trial summary
This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural, Lidocaine, Obstetric Surgical Procedures
- What is being tested?
- 10 % lidocaine spray without adrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteThailand
- Study dates
- 14 Dec 2023to 30 Jul 2024
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia
Who cannot join
- patient with allergic to lidocaine or history of allergic to lidocaine
- patient with reproductive and urinary infection
- patient with abnormal vital sign
- patient with abnormal kidney and liver function test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration : A Randomized Controlled Trial
This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration
Read the detailed description
This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.
- Conditions
- Pain, Procedural, Lidocaine, Obstetric Surgical Procedures
- Being tested
- 10 % lidocaine spray without adrenaline, Placebo
- Keywords
- manual vacuum aspiration, pain score, Lidocaine spray
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 % lidocaine spray without adrenalineDrug
Also called 10% Xylocaine spray
Pateint with indication for manual vacuum aspiration aged between 20-60 years will received a standard injection of pethidine along with 1% lidocaine spray without adrenaline on cervical os to compare pain scores with placebo. Along with measuring side effects immediately and 30 minutes after receiving 1% lidocaine without adrenaline.
PlaceboOther
4 puffs of normal saline apply on cervical os before manual vacuum aspiration
| Study group | Role | What they receive |
|---|---|---|
| 10% lidocaine spray without adrenaline | Experimental | 4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration Receives: Drug: 10 % lidocaine spray without adrenaline |
| Placebo | Placebo comparator | 4 puffs of normal saline apply on cervical os before manual vacuum aspiration Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score during manual vauum aspiration
The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain
Measured: during surgery
pain score after manual vauum aspiration
The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain
Measured: at 30 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start14 Dec 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- UdonThani Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Metha Songthamwat, UdonThani Hospital
- Investigators
- PATTARIKAN MANAYING, Principal investigator, UdonThani Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344637
- Sponsor's protocol ID
- 2566/081 I
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 3 Apr 2024
- Results posted
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06344637
- Acronym / sponsor ID
- 2566/081 I
- Conditions
- Pain, Procedural, Lidocaine, Obstetric Surgical Procedures
- Keywords
- manual vacuum aspiration, pain score, Lidocaine spray
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (actual)
- Lead sponsor
- UdonThani HospitalOther government
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration
Detailed description
This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% lidocaine spray without adrenaline | Experimental | Drug: 10 % lidocaine spray without adrenaline4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration |
| Placebo | Placebo comparator | Other: Placebo4 puffs of normal saline apply on cervical os before manual vacuum aspiration |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia
Key exclusion criteria (4 listed)
- patient with allergic to lidocaine or history of allergic to lidocaine
- patient with reproductive and urinary infection
- patient with abnormal vital sign
- patient with abnormal kidney and liver function test
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 |
|---|---|---|
| 10 % lidocaine spray without adrenalineAlso: 10% Xylocaine sprayPateint with indication for manual vacuum aspiration aged between 20-60 years will received a standard injection of pethidine along with 1% lidocaine spray without adrenaline on cervical os to compare pain scores with placebo. Along with measuring side effects immediately and 30 minutes after receiving 1% lidocaine without adrenaline. | Drug | 10% lidocaine spray without adrenaline |
| Placebo4 puffs of normal saline apply on cervical os before manual vacuum aspiration | Other | Placebo |
Primary outcome
pain score during manual vauum aspiration
Time frame: during surgery
The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain
pain score after manual vauum aspiration
Time frame: at 30 minutes postoperative
The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
PATTARIKAN MANAYING principal investigator
UdonThani 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 10 % lidocaine spray without adrenaline in people with Pain, Procedural and Lidocaine, run by UdonThani Hospital at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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 Thailand. 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?
Results are not available in the source record.
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 score during manual vauum aspiration (time frame: during surgery). The study lists 2 primary outcomes in all. 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 3 Apr 2024.