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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03298646
Other study ID # Hysteroscopy
Secondary ID
Status Recruiting
Phase N/A
First received August 30, 2017
Last updated September 29, 2017
Start date October 2017
Est. completion date January 2018

Study information

Verified date September 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date January 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Age: 18-35 years.

- BMI 18.5-30 Kg.

- Nulliparous women assigned for diagnostic hysteroscopy.

- Informed written consent.

Exclusion Criteria:

- Previous cervical surgery.

- Cervical stenosis.

- Known gastritis.

- Recent or active PID.

- Cardiac patients.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine Hydrochloride
10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.
Diclofenac
100 mg Diclofenac oral tablet one hour before the procedure.

Locations

Country Name City State
Egypt Ain Shams maternity hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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