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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03701984
Other study ID # hysteroscopy
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 15, 2018
Est. completion date August 15, 2019

Study information

Verified date November 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women.


Description:

The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women. Postmenopausal Women undergoing outpatient hysteroscopy in Cairo university will be divided into three groups, the first group will receive Tramadol 5mg 1 hour before the procedure, the second group will receive 20 ml lidocaine in 1000 ml normal saline infusion during the procedure, and the third will receive a placebo. A visual analog scale will assess pain.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date August 15, 2019
Est. primary completion date August 10, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

- Consent to the procedure

Exclusion Criteria:

- Positive Chlamydia culture.

- patients who have an Allergy to local anesthesia or tramadol.

- A previous adverse reaction to any of the drugs used in the study.

- Patients were receiving any form of analgesia or current use of monoamine oxidase inhibitors.

- Nulliparous patients and patients with cervical pathology, retroverted uterus (detected by transvaginal ultrasound), and previous cervical surgery.

- Patients who have severe vaginal bleeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
The lidocaine group will be administered a 1,000 ml distention medium containing 5 ml lidocaine per 250 ml (DEBOCAINE (LIDOCAINE) 2% 1 VIAL 50 ML, Sigma-Tec pharmaceutical Industry. Co. Egypt) and oral placebo similar to tramadol(given 1 hour before the procedure).
Tramadol
an oral tramadol tablet (Tramal®, Memphis, Giza, Egypt) 1 h before the procedure and with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml.
placebo
a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).

Locations

Country Name City State
Egypt faculty of medicine Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain perception during the procedure The pain will be assessed using a visual analogue scale(VAS) after inserting the hysteroscope through the cervical canal.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. The pain VAS is self-completed by the patients. The patients are asked to place a line perpendicular to the VAS line at the point that represents their pain intensity 10 minutes after starting the procedure.
Secondary Pain perception after the procedure Pain will be assessed using a visual analog scale(VAS) 10 minutes after the procedure.
VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.
The pain VAS is self-completed by the patient. The patients are asked to place a line perpendicular to the VAS line at the point that represents their pain intensity
10 minutes after the procedure.
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