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NCT Number: NCT03701984

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

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.

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Key information

Conditions

Hysteroscopy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine Cairo university

Giza, 11231, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

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).

Other names: lidocaine infusion arm

Tramadol

Drug

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.

Other names: tramadol HCL arm

Placebo

Drug

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

Other names: placebo arm

Primary outcomes

  1. Pain perception during the procedure

    Time frame: 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 outcomes

  1. Pain perception after the procedure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2018
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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