Topical Analgesia for Pain Relief in Hysterosalpingography

NCT03802032 | Completed

• 1 other identifier: Ahmadu Bello University
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study will involve giving topical analgesia or placebo and then assessing pain and satisfaction during and after the procedure in order to see wed to the placebo.hether the topical analgesia has helped in decreasing pain associated with the procedure and also whether it has increasedd satisfaction with the procedure compar

Conditions

Infertility, Female

Keywords

infertility; hysterosalpingography; pain

Outcome Measures

Primary Outcomes (1)

• Pain perception

  The pain score based on visual pain scale that assesses pain perception. It is a scale of 0 to 10. 0 = absence of pain. 1. = discomfort 2. = mild pain. 3. = annoying pain. 4. = nagging pain. 5. = distressing pain. 6. = miserable. 7. = intense 8. = Dreadful. 9. = worse possible 10. = unbearable

  witthin 45 minutes of the procedure

Secondary Outcomes (1)

• Patients Satisfaction with procedure

  witthin 45 minutes of the procedure

Study Arms (2)

Study Group

EXPERIMENTAL

15g of Topical Xylocaine gel

Drug: Lidocaine Gel

Control group

PLACEBO COMPARATOR

15g of KY Jelly

Drug: KY jelly

Interventions

Lidocaine Gel DRUG

topical lidocaine gel

Study Group

KY jelly DRUG

topical KY jelly

Control group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: based on biological gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All women that are sent in to the department of radiology for Hysterosalpingogram as part of evaluation for infertility that give consent.

You may not qualify if:

• Women that present for hysterosalpingography for other indications apart from infertility and those that have history of allergy to xylocaine and/or K-Y jelly.

Sponsors & Collaborators

• Ahmadu Bello University Teaching Hospital: lead

Study Sites (1)

Ahmadu Bello University Teaching Hospital Shika-Zaria

Zaria, Kaduna State, PMB 06, Nigeria

Location

MeSH Terms

Conditions

Infertility, Female; Infertility; Pain

Interventions

K-Y jelly

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anisah Yahya, MBBS

  Ahmadu Bello University Zaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A randomised controlled trial

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: February 1, 2019
• Primary Completion: December 22, 2019
• Study Completion: December 22, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: within 6 months of completion
• Access Criteria: free

Locations

NG (1)