Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography (HBTB)

Assiut University

Status and phase: Completed; Phase 2

Conditions: Pain Relief

Treatments: Drug: oral hyoscine butyl bromide tablets plus lidocaine cream; Drug: oral placebo tablets plus placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02710305

HS1

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

oral hyoscine butyl bromide tablets plus lidocaine cream

Treatment:

Drug: oral hyoscine butyl bromide tablets plus lidocaine cream

Group B

Placebo Comparator group

Description:

oral placebo tablets plus placebo cream

Treatment:

Drug: oral placebo tablets plus placebo cream