Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863679
• Other study ID #: Tetracaine hydrochloride gel
• Status: Completed
• Phase: N/A
• First received: August 8, 2016
• Last updated: October 11, 2016
• Start date: May 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	the 1st Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) score		7 days
Secondary	patients received balloon volume reduction		1 day