The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy

Hysteroscopy Clinical Trial

Official title:

The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy in Postmenopausal Women: Randomized Double-Blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701984
• Other study ID #: hysteroscopy
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Hysteroscopy

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.