Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

NCT ID: NCT02863679

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-09-30

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.

Conditions

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Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tetracaine hydrochloride gel group

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.

Group Type EXPERIMENTAL

Tetracaine hydrochloride gel

Intervention Type DRUG

Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.

Control group

Patients in control group were covered with a gauze with saline on the cervix after hysteroscopic insertion of utrauterine balloon stent.

Group Type PLACEBO_COMPARATOR

Tetracaine hydrochloride gel

Intervention Type DRUG

Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.

Interventions

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Tetracaine hydrochloride gel

Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.

Intervention Type DRUG

Other Intervention Names

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Tetracaine HCL

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Feng Lin

attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Lin, MD

Role: PRINCIPAL_INVESTIGATOR

The 1st Affiliated Hospital of Wenzhou Medical University

Locations

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the 1st Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 12764338 (View on PubMed)

Amiel 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.

Reference Type BACKGROUND
PMID: 17189801 (View on PubMed)

Other Identifiers

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Tetracaine hydrochloride gel

Identifier Type: -

Identifier Source: org_study_id

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