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

NCT03701984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2019-11-18

No results posted yet for this study

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.

Conditions

  • Hysteroscopy

Interventions

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).

DRUG

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.

DRUG

placebo

a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED S ASHOUR, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2019-08-10
Completion
2019-08-15

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701984 on ClinicalTrials.gov