Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

Not Applicable

Completed

• Conditions: Hysteroscopy
• Interventions: Drug: Tetracaine hydrochloride gel

• Registration Number: NCT02863679
• Lead Sponsor: Wenzhou Medical University

Brief 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tetracaine hydrochloride gel group	Tetracaine hydrochloride gel	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.
Control group	Tetracaine hydrochloride gel	Patients in control group were covered with a gauze with saline on the cervix after hysteroscopic insertion of utrauterine balloon stent.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) score	7 days

Secondary Outcome Measures

Name	Time	Method
patients received balloon volume reduction	1 day

Trial Locations

Locations (1)

the 1st Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China