Hysteroscopy
Conditions
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.
Interventions
DRUGLidocaine
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).
DRUGTramadol
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.
DRUGplacebo
a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed