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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Hysteroscopy

Treatments: Drug: Tramadol; Drug: Lidocaine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03701984

hysteroscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 3 patient groups, including a placebo group

lidocaine infusion arm

Experimental group

Description:

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).

Treatment:

Drug: Lidocaine

tramadol arm

Active Comparator group

Description:

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.

Treatment:

Drug: Tramadol

placebo group

Placebo Comparator group

Description:

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).

Treatment:

Drug: placebo