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NCT Number: NCT02863679

Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

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.

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Key information

Conditions

Hysteroscopy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

the 1st Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetracaine hydrochloride gel

Drug

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

Other names: Tetracaine HCL

Primary outcomes

  1. Numerical Rating Scale (NRS) score

    Time frame: 7 days

Secondary outcomes

  1. patients received balloon volume reduction

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2016
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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