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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Relief
• Intervention / Treatment: Drug: oral hyoscine butyl bromide tablets plus lidocaine cream; Drug: oral placebo tablets plus placebo cream

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain score during HSG	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean pain score after HSG	30 minutes
rate of side effects	30 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 8, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Membrane Transport Modulators; Adjuvants, Anesthesia; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Mydriatics; Lidocaine; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: HS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided