NCT02863679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

August 8, 2016

Last Update Submit

October 11, 2016

Conditions

Hysteroscopy

Keywords

tetracaine hydrochloride gelanalgesiaintrauterine balloonhysteroscope operation

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) score

    7 days

Secondary Outcomes (1)

  • patients received balloon volume reduction

    1 day

Study Arms (2)

Tetracaine hydrochloride gel group

EXPERIMENTAL

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.

Drug: Tetracaine hydrochloride gel

Control group

PLACEBO COMPARATOR

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

Drug: Tetracaine hydrochloride gel

Interventions

Tetracaine hydrochloride gelDRUG

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

Also known as: Tetracaine HCL
Control groupTetracaine hydrochloride gel group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • no previous history of hysteroscopic adhesiolysis or surgery on the cervix
  • inserted intrauterine balloon in the uterine cavity after hysteroscopic adhesiolysis
  • no other diseases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 1st Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (2)

  • 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.

    PMID: 12764338BACKGROUND

  • 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.

    PMID: 17189801BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Tetracaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Feng Lin, MD

    The 1st Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)