NCT03298646

Brief Summary

Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

August 30, 2017

Last Update Submit

September 29, 2017

Conditions

Nulliparity

Outcome Measures

Primary Outcomes (1)

  • Pain reduction using Visual Analogue Scale

    Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain

    30 minutes

Study Arms (2)

Lidacaine hydrochloride

EXPERIMENTAL

Adding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain. 22 women.

Drug: Lidocaine Hydrochloride

Diclofenac

ACTIVE COMPARATOR

100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain. 22 women.

Drug: Diclofenac

Interventions

Lidocaine HydrochlorideDRUG

10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.

Lidacaine hydrochloride
DiclofenacDRUG

100 mg Diclofenac oral tablet one hour before the procedure.

Diclofenac

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-35 years.
  • BMI 18.5-30 Kg.
  • Nulliparous women assigned for diagnostic hysteroscopy.
  • Informed written consent.

You may not qualify if:

  • Previous cervical surgery.
  • Cervical stenosis.
  • Known gastritis.
  • Recent or active PID.
  • Cardiac patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

LidocaineDiclofenac

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

October 2, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

EG(1)