HysteroscopyNCT02863679
Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel
A study testing Tetracaine hydrochloride gel in people with Hysteroscopy, run by Wenzhou Medical University at 1 site in China.
Trial summary
This study was taken out to assess the postoperative analgesic efficacy of tetracaine hydrochloride gel in patients with intrauterine adhesion treating with intrauterine balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel group and control group. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Tetracaine hydrochloride gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Sep 2016
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- no previous history of hysteroscopic adhesiolysis or surgery on the cervix
- inserted intrauterine balloon in the uterine cavity after hysteroscopic adhesiolysis
- no other diseases
Who cannot join
- Allergy to local anesthetics
- Patients with chronic pain
- Patients with abnormal blood coagulation function
- Patients with mental illness that can not cooperate
- Patients with previous hysteroscopic adhesiolysis or cervical surgery
Trial locations and contacts
1 site in 1 country.
China1 site
the 1st Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
About this study
Official title: Topical Anesthesia of Tetracaine Hydrochloride Jelly on Cervix After Hysteroscopic Uterine Stent Insertion
This study was taken out to assess the postoperative analgesic efficacy of tetracaine hydrochloride gel in patients with intrauterine adhesion treating with intrauterine balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel group and control group.
Read the detailed description
Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics. Patients in getracaine hydrochloride gel group were covered with a gauze of tetracaine hydrochloride gel on the external cervical orifice after insert an utrauterine balloon in the uterine cavity. While patients in the control group were covered with a blank gauze after hysteroscopic adhesiolysis. Compare the postoperative analgesic scor and patients' analgesic satisfaction of the two groups and asess the analgesic efficacy of tetracaine hydrochloride gel.
- Conditions
- Hysteroscopy
- Being tested
- Tetracaine hydrochloride gel
- Keywords
- tetracaine hydrochloride gel, analgesia, intrauterine balloon, hysteroscope operation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracaine hydrochloride gelDrug
Also called Tetracaine HCL
Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| Tetracaine hydrochloride gel group | Experimental | Patients in getracaine hydrochloride gel group were covered with a gauze with tetracaine hydrochloride gel on the cervix after hysteroscopic insertion of utrauterine balloon stent. Receives: Drug: Tetracaine hydrochloride gel |
| Control group | Placebo comparator | Patients in control group were covered with a gauze with saline on the cervix after hysteroscopic insertion of utrauterine balloon stent. Receives: Drug: Tetracaine hydrochloride gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) score
Measured: 7 days
Secondary outcomes (1)
patients received balloon volume reduction
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies 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, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Lin, Wenzhou Medical University
- Investigators
- Feng Lin, MD, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863679
- Sponsor's protocol ID
- Tetracaine hydrochloride gel
- Status last verified
- Oct 2016
- First submitted
- 8 Aug 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Weaver CS, Rusyniak DE, Brizendine EJ, Abel S, Somerville GG, Howard JD, Root T. A prospective, randomized, double-blind comparison of buffered versus plain tetracaine in reducing the pain of topical ophthalmic anesthesia. Ann Emerg Med. 2003 Jun;41(6):827-31. doi: 10.1067/mem.2003.192.
PubMed 12764338Amiel H, Koch PS. Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery: comparative clinical trial. J Cataract Refract Surg. 2007 Jan;33(1):98-100. doi: 10.1016/j.jcrs.2006.09.013.
PubMed 17189801
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthesia of Tetracaine Hydrochloride Jelly on Cervix After Hysteroscopic Uterine Stent Insertion
- ClinicalTrials.gov ID
- NCT02863679
- Acronym / sponsor ID
- Tetracaine hydrochloride gel
- Conditions
- Hysteroscopy
- Keywords
- tetracaine hydrochloride gel, analgesia, intrauterine balloon, hysteroscope operation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Aug 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.
This study was taken out to assess the postoperative analgesic efficacy of tetracaine hydrochloride gel in patients with intrauterine adhesion treating with intrauterine balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel group and control group.
Detailed description
Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics. Patients in getracaine hydrochloride gel group were covered with a gauze of tetracaine hydrochloride gel on the external cervical orifice after insert an utrauterine balloon in the uterine cavity. While patients in the control group were covered with a blank gauze after hysteroscopic adhesiolysis. Compare the postoperative analgesic scor and patients' analgesic satisfaction of the two groups and asess the analgesic efficacy of tetracaine hydrochloride gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracaine hydrochloride gel group | Experimental | Drug: Tetracaine hydrochloride gelPatients in getracaine hydrochloride gel group were covered with a gauze with tetracaine hydrochloride gel on the cervix after hysteroscopic insertion of utrauterine balloon stent. |
| Control group | Placebo comparator | Drug: Tetracaine hydrochloride gelPatients in control group were covered with a gauze with saline on the cervix after hysteroscopic insertion of utrauterine balloon stent. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- no previous history of hysteroscopic adhesiolysis or surgery on the cervix
- inserted intrauterine balloon in the uterine cavity after hysteroscopic adhesiolysis
- no other diseases
Key exclusion criteria (5 listed)
- Allergy to local anesthetics
- Patients with chronic pain
- Patients with abnormal blood coagulation function
- Patients with mental illness that can not cooperate
- Patients with previous hysteroscopic adhesiolysis or cervical surgery
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 |
|---|---|---|
| Tetracaine hydrochloride gelAlso: Tetracaine HCLTetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics. | Drug | Control group, Tetracaine hydrochloride gel group |
Primary outcome
Numerical Rating Scale (NRS) score
Time frame: 7 days
1 secondary outcome
patients received balloon volume reduction
Time frame: 1 day
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 12 Oct 2016.
- Background: PubMed 12764338Weaver CS, Rusyniak DE, Brizendine EJ, Abel S, Somerville GG, Howard JD, Root T. A prospective, randomized, double-blind comparison of buffered versus plain tetracaine in reducing the pain of topical ophthalmic anesthesia. Ann Emerg Med. 2003 Jun;41(6):827-31. doi: 10.1067/mem.2003.192.
- Background: PubMed 17189801Amiel H, Koch PS. Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery: comparative clinical trial. J Cataract Refract Surg. 2007 Jan;33(1):98-100. doi: 10.1016/j.jcrs.2006.09.013.
- Individual participant dataSharing planned: No
Related trials for Hysteroscopy
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Uterine Polyps, Uterine Fibroids
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
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Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
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.
Feng Lin, MD principal investigator
First Affiliated Hospital of Wenzhou Medical 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 Tetracaine hydrochloride gel in people with Hysteroscopy, run by Wenzhou Medical University at 1 site in China.
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 3 inclusion and 5 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 12 Oct 2016. 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 China. 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?
Numerical Rating Scale (NRS) score (time frame: 7 days). 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 NCT02863679, which also lists 2 linked publications.
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 12 Oct 2016.