Pain Management During Diagnostic Office Hysteroscopy in... | NCT06767085

Studies
Pain Management During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Study

NCT06767085

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Jan 9, 2025Actual

Enrollment

106Estimated

Phase

Phase 4

Conditions

Office Hysteroscopy

Interventions

Lidocaine-Prilocaine Topical
Saline spray

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2025Estimated

Primary Completion Date

Jul 5, 2025Estimated

Completion Date

Jul 25, 2025Estimated

First Submitted Date

Jan 5, 2025

First Submission Date that Met QC Criteria

Jan 5, 2025

First Posted Date

Jan 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2025

Last Update Posted Date

Jan 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine prilocaine	Experimental		Drug: Lidocaine-Prilocaine Topical
placebo	Placebo Comparator		Drug: Saline spray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine-Prilocaine Topical	Drug	lidocaine-prilocaine spray on the cervix and cervical canal 5-7 minutes prior to the procedure	lidocaine prilocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity of pain	Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Intensity of pain	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10	20 minutes
ease of insertion	ease of insertion by 10 CM VAS LIKE SCORE in which 10 means terribly difficult entry and 0 means very easy entry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AHMED SAMY ALI ASHOUR, MD	Contact	01100681167		ahmedsamy8233@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077442	Lidocaine, Prilocaine Drug Combination

Ancestor Terms

ID	Term
D008012	Lidocaine
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided