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

Phase 4

Completed

• Conditions: Hysteroscopy
• Interventions: Drug: Tramadol; Drug: placebo; Drug: Lidocaine

• Registration Number: NCT03701984
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-10
• Study Start: 2018-10-15
• Primary Completion: 2019-08-10
• Study Completion: 2019-08-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tramadol arm	Tramadol	will be administered with 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 group	placebo	will be administered with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
lidocaine infusion arm	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).

Primary Outcome Measures

Name	Time	Method
Pain perception during the procedure	10 minutes after starting 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

Secondary Outcome Measures

Name	Time	Method
Pain perception after the procedure	10 minutes 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

Trial Locations

Locations (1)

faculty of medicine Cairo university; 🇪🇬 Giza, Egypt