Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

Wenzhou Medical University

Status: Completed

Conditions: Hysteroscopy

Treatments: Drug: Tetracaine hydrochloride gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02863679

Tetracaine hydrochloride gel

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Tetracaine hydrochloride gel group

Experimental group

Description:

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.

Treatment:

Drug: Tetracaine hydrochloride gel

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Tetracaine hydrochloride gel