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

Phase 4CompletedNCT03701984

Cairo University156 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

156

Conditions

Hysteroscopy

Interventions

LidocaineDRUG

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).

TramadolDRUG

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.

placeboDRUG

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

faculty of medicine Cairo university

Giza, Egypt

Outcomes

Primary Outcomes

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

Time frame: 10 minutes after starting the procedure.

Secondary Outcomes

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

Time frame: 10 minutes after the procedure.

Data from ClinicalTrials.gov

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