Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topical Anesthesia of Tetracaine Hydrochloride Jelly on Cervix After Hysteroscopic Uterine Stent Insertion

Conditions
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Hysteroscopy

Intervention / Treatment
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* Drug: Tetracaine hydrochloride gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no previous history of hysteroscopic adhesiolysis or surgery on the cervix inserted intrauterine balloon in the uterine cavity after hysteroscopic adhesiolysis no other diseases Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tetracaine hydrochloride gel group<br>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. | Drug: Tetracaine hydrochloride gel<br>* Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.<br>* Other names: Tetracaine HCL;|
| Placebo Comparator: Control group<br>Patients in control group were covered with a gauze with saline on the cervix after hysteroscopic insertion of utrauterine balloon stent. | Drug: Tetracaine hydrochloride gel<br>* Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.<br>* Other names: Tetracaine HCL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) score |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients received balloon volume reduction |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tetracaine hydrochloride gel, analgesia, intrauterine balloon, hysteroscope operation