Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography
Phase 2
Completed
- Conditions
- Pain Relief
- Interventions
- Drug: oral hyoscine butyl bromide tablets plus lidocaine creamDrug: oral placebo tablets plus placebo cream
- Registration Number
- NCT02710305
- Lead Sponsor
- Assiut University
- Brief Summary
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 140
Inclusion Criteria
• The infertile women who indicated for HSG
Exclusion Criteria
- contraindications to Hyoscine or lidocaine
- known sensitivity to contrast media
- abnormal uterine bleeding
- genital tract infection
- suspected pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A oral hyoscine butyl bromide tablets plus lidocaine cream oral hyoscine butyl bromide tablets plus lidocaine cream Group B oral placebo tablets plus placebo cream oral placebo tablets plus placebo cream
- Primary Outcome Measures
Name Time Method Mean pain score during HSG intraoperative
- Secondary Outcome Measures
Name Time Method rate of side effects 30 minutes Mean pain score after HSG 30 minutes
Trial Locations
- Locations (1)
Ahmed Abbas
🇪🇬Assiut, Cairo, Egypt