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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02710305

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Relief	Drug: oral hyoscine butyl bromide tablets plus lidocaine cream Drug: oral placebo tablets plus placebo cream	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A oral hyoscine butyl bromide tablets plus lidocaine cream	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
Placebo Comparator: Group B oral placebo tablets plus placebo cream	Drug: 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

Arm

Intervention/Treatment

Active Comparator: Group A

oral hyoscine butyl bromide tablets plus lidocaine cream

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

Placebo Comparator: Group B

oral placebo tablets plus placebo cream

Drug: 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

Outcome Measures

Primary Outcome Measures

Mean pain score during HSG [intraoperative]

Secondary Outcome Measures

Mean pain score after HSG [30 minutes]
rate of side effects [30 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02710305

Other Study ID Numbers:

First Posted:

Mar 16, 2016

Last Update Posted:

Jan 10, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Lidocaine

Scopolamine

Bromides

Butylscopolammonium Bromide

Study Results

No Results Posted as of Jan 10, 2017