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

Pain Relief Clinical Trial

— HBTB  

Official title:

Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710305
• Other study ID #: HS1
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2016
• Last updated: January 8, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain Relief

Intervention

Drug:
• oral hyoscine butyl bromide tablets plus lidocaine cream
patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure
• oral placebo tablets plus placebo cream
patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain score during HSG		intraoperative	Yes
Secondary	Mean pain score after HSG		30 minutes	Yes
Secondary	rate of side effects		30 minutes	Yes