NCT02355522

Brief Summary

This is a randomized, double-blinded, double placebo-controlled trial. Patients undergoing saline infusion sonohysterography (SIS) will be recruited and randomized into three groups to receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline; (b) 3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY jelly on the cervix and 5mL of intrauterine normal saline prior to SIS. Pain levels will be recorded to evaluate the efficacy of local lidocaine gel and intrauterine lidocaine infusion in reducing pain during the SIS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

January 30, 2015

Last Update Submit

March 23, 2016

Conditions

Pain

Keywords

saline infusion sonohysterography

Outcome Measures

Primary Outcomes (1)

  • Pain level as assessed by the visual analog scale

    Pain level during and after the saline infusion sonohysterography procedure as assessed by the visual analog scale

    Up to 20 minutues after the procedure

Secondary Outcomes (3)

  • Distress as evaluated by the physician with a 3-point observer scale

    Just after the procedure

  • Analgesics

    1 hour

  • Side effects

    1 hour

Study Arms (3)

Lidocaine gel group

ACTIVE COMPARATOR

3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline

Drug: Lidocaine gelDrug: Intrauterine normal saline

Intrauterine lidocaine group

ACTIVE COMPARATOR

3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine

Drug: Intrauterine lidocaineDrug: KY jelly

Placebo group

PLACEBO COMPARATOR

3ml of KY jelly on the cervix and 5mL of intrauterine normal saline

Drug: KY jellyDrug: Intrauterine normal saline

Interventions

Intrauterine lidocaineDRUG
Intrauterine lidocaine group
Lidocaine gelDRUG
Lidocaine gel group
KY jellyDRUG
Intrauterine lidocaine groupPlacebo group
Intrauterine normal salineDRUG
Lidocaine gel groupPlacebo group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 years or older being scheduled for saline infusion sonohysterography

You may not qualify if:

  • History of cervical stenosis
  • Known allergy to lidocaine
  • Pregnancy
  • Acute cervicitis
  • Profuse vaginal bleeding
  • Consumption of pain killers on the day of procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Pain

Interventions

K-Y jelly

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sofie SF Yung, MBBS, MRCOG, FHKAM(O&G)

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

CN(1)