Hysteroscopy Clinical Trial
Official title:
The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy in Postmenopausal Women: Randomized Double-Blind Controlled Study
Verified date | November 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | August 15, 2019 |
Est. primary completion date | August 10, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of medicine Cairo university | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 10 minutes after starting the procedure. | |
Secondary | 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 |
10 minutes after the procedure. |
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