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Pilot Study of effect of topical anaesthetic on cervical compliance.

A pilot study to evaluate the effects of topical anaesthetic fluid, injected into the cervical canal, to relax the fibro-elastic tissues of the cervix to increase patient comfort and safety for outpatient hysteroscopy.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000713695
Enrollment
40
Registered
2005-11-04
Start date
2005-01-11
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Following the introduction of anaesthetic ***INTO THE UTERINE CAVITY*** the patient will be cleaned and draped for their procedure in routine fashion whilst the surgeons scrub. The agent must be left within the endometrial cavity for 6 minutes prior to testing cervical compliance. After 6 minutes a disposable intra-uterine catheter (usually used for performing hystero-salpingograms) will be passed into the endometrial cavity. A small balloon at the end of the device will be inflated with ***1.0*

Following the introduction of anaesthetic ***INTO THE UTERINE CAVITY*** the patient will be cleaned and draped for their procedure in routine fashion whilst the surgeons scrub. The agent must be left within the endometrial cavity for 6 minutes prior to testing cervical compliance. After 6 minutes a disposable intra-uterine catheter (usually used for performing hystero-salpingograms) will be passed into the endometrial cavity. A small balloon at the end of the device will be inflated with ***1.0*** ml saline and the balloon withdrawn till some resistance is felt as the balloon reaches the internal cervical os. At this point a force gauge (supplied by department of biomedical engineering, sensitive to within 10 grams) is attached to the end of the catheter. The inflated balloon is then withdrawn through the cervix and the maximum force required to pass the balloon through the internal cervical os is recorded

Sponsors

Associate Professor Thierry Vancaillie
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Having elective laparoscopic or hysteroscopic surgeryIntact uterus.

Exclusion criteria

Currently menstruatingSuspected diagnosis of gynaecological malignancies or precursorsPossibility of current pregnancy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026