Topical Analgesia for Pain Relief in Hysterosalpingography

NCT ID: NCT03802032

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-12-22

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

Detailed Description

STUDY DESIGN:

The study will be a double blind randomized controlled trial. Group A:The study group will be given topical Xylocaine (2% Lidocaine) before the procedure.

Group B:The control group will be given topical K-Y jelly (water based lubricant) before the procedure.

The participants and the radiologist will be blinded at the point of drug administration.

SAMPLE SIZE DETERMINATION:

The formula below was used to calculate the sample size n= (Zα + Zβ)2S2 d2

Assuming a difference in mean pain score among groups of 1.5 and using a standard deviation of of 3.15.

Zα = standard normal deviate. Zβ = power = 95% = 1.64. S = standard deviation = 3.1. D = mean difference in pain score = 1.5 n = (1.96 + 1.64)2 x 3.12 1.52

n = 55 Sample size per group will be rounded up to 60

SAMPLING APPROACH:

A probability sampling method will be used. Simple random sampling using a computer generated table of random numbers will be used. The WINPEPI version 11.65 software will generate the table of random numbers. The numbers 001-140 will be randomly allocated to two groups A and B. Group A will be the study group and group B will be the control group (see appendix). Each number from the table of random numbers will be copied on separate paper and then sealed in a brown envelope. The envelopes will then be kept inside a box after shuffling.

Each patient will be allocated to the group that the number she picks corresponds to on the computer printout. The numbers were made up to 140 to make up for patients that may eventually drop out from the study.

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SAMPLING RECRUITEMENT:

Women that fulfil the inclusion criteria will be recruited from radiology department as they present for Hysterosalpingogram. After obtaining a written consent, participants will be requested to pick one of the brown envelopes which will contain the randomization group.

BLINDING The drugs to be used (K-Y Jelly and Xylocaine gel) are identical.

DATA COLLECTION METHOD:

An informed written consent will be obtained from participants. Psychological support will be given to the participant by a nurse after the procedure has been explained to the participant. A questionnaire will then be filled. The participant will then be requested to pick an envelope that represents the study number. A detailed explanation about the VAS and its application was given personally to each woman before the procedure. An interviewer administered questionnaire will be used to obtain information on socio-demographic characteristics, reproductive profile, previous history of the procedure and experience with analgesia.

The analgesic or placebo will be applied to the cervix (15ml) using a vaginal applicator 10 minutes before the procedure.

The procedure will then be done using standard clinical protocol. The pain rating scale will be used to evaluate pain during from zero (no pain) to ten (worst possible pain) will be explained to the client. The visual scale comparison to happy, glum, sad and horrified faces will also be explained to the patient.

Pain assessment will be done during the procedure at the following steps:

1. After application of speculum.

2. After cervical manipulation (application of tenaculum and catheter).

3. After filling the uterus with contrast medium.

4. After withdrawal of speculum and catheter.

5. Thirty minutes after completing the procedure.

The Likert scale will be used to assess patient satisfaction following pain management.

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Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Group

15g of Topical Xylocaine gel

Group Type: EXPERIMENTAL

Lidocaine Gel

Intervention Type: DRUG

topical lidocaine gel

Control group

15g of KY Jelly

Group Type: PLACEBO_COMPARATOR

KY jelly

Intervention Type: DRUG

topical KY jelly

Interventions

Lidocaine Gel

topical lidocaine gel

Intervention Type: DRUG

KY jelly

topical KY jelly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ahmadu Bello University Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anisah Yahya

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anisah Yahya, MBBS

Role: PRINCIPAL_INVESTIGATOR

Ahmadu Bello University Zaria

Locations

Ahmadu Bello University Teaching Hospital Shika-Zaria

Zaria, Kaduna State, Nigeria

Countries

Nigeria

Other Identifiers

Ahmadu Bello University

Identifier Type: -

Identifier Source: org_study_id