Infertility, FemaleHSGNCT03802032
Topical Analgesia for Pain Relief in Hysterosalpingography
A study testing Lidocaine Gel and KY jelly in people with Infertility, Female, run by Ahmadu Bello University Teaching Hospital at 1 site in Nigeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Lidocaine Gel and KY jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Feb 2019to 22 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women that are sent in to the department of radiology for Hysterosalpingogram as part of evaluation for infertility that give consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Ahmadu Bello University Teaching Hospital Shika-Zaria
Zaria, Kaduna State, PMB 06
About this study
Official title: Effect of Topical Xylocaine for Pain Relief During Hysterosalpingography Among Infertile Women in Zaria, Nigeria: A Randomised Controlled Trial.
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
Read the 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.
.
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:
- After application of speculum.
- After cervical manipulation (application of tenaculum and catheter).
- After filling the uterus with contrast medium.
- After withdrawal of speculum and catheter.
- Thirty minutes after completing the procedure.
The Likert scale will be used to assess patient satisfaction following pain management.
.
- Conditions
- Infertility, Female
- Being tested
- Lidocaine Gel, KY jelly
- Keywords
- infertility, hysterosalpingography, pain
- Medical subject headings
- Infertility, Female, Infertility, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine GelDrug
topical lidocaine gel
KY jellyDrug
topical KY jelly
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 15g of Topical Xylocaine gel Receives: Drug: Lidocaine Gel |
| Control group | Placebo comparator | 15g of KY Jelly Receives: Drug: KY jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- = discomfort
- = mild pain.
- = annoying pain.
- = nagging pain.
- = distressing pain.
- = miserable.
- = intense
- = Dreadful.
- = worse possible
- = unbearable
Measured: witthin 45 minutes of the procedure
Secondary outcomes (1)
Patients Satisfaction with procedure
Satisfaction with the procedure based on Likert scale. The scale is from 1 to 5.
- = Very dissatisfied.
- = Dissatisfied..
- = Neither satisfied nor dissatisfied.
- = Satisfied.
- = Very satisfied.
Measured: witthin 45 minutes of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Feb 2019
- Primary completion22 Dec 2019
- Study completion22 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmadu Bello University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisah Yahya, Ahmadu Bello University Teaching Hospital
- Investigators
- Anisah Yahya, MBBS, Principal investigator, Ahmadu Bello University Zaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802032
- Sponsor's protocol ID
- Ahmadu Bello University
- Acronym
- HSG
- Status last verified
- Aug 2020
- First submitted
- 10 Jan 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: obtained data and result will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Xylocaine for Pain Relief During Hysterosalpingography Among Infertile Women in Zaria, Nigeria: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03802032
- Acronym / sponsor ID
- HSG / Ahmadu Bello University
- Conditions
- Infertility, Female
- Keywords
- infertility, hysterosalpingography, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ahmadu Bello University Teaching HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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:
- After application of speculum.
- After cervical manipulation (application of tenaculum and catheter).
- After filling the uterus with contrast medium.
- After withdrawal of speculum and catheter.
- Thirty minutes after completing the procedure.
The Likert scale will be used to assess patient satisfaction following pain management.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Lidocaine Gel15g of Topical Xylocaine gel |
| Control group | Placebo comparator | Drug: KY jelly15g of KY Jelly |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women that are sent in to the department of radiology for Hysterosalpingogram as part of evaluation for infertility that give consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine Geltopical lidocaine gel | Drug | Study Group |
| KY jellytopical KY jelly | Drug | Control group |
Primary outcome
Pain perception
Time frame: witthin 45 minutes of the procedure
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
1 secondary outcome
Patients Satisfaction with procedure
Time frame: witthin 45 minutes of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: Yes. obtained data and result will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anisah Yahya, MBBS principal investigator
Ahmadu Bello University Zaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Gel and KY jelly in people with Infertility, Female, run by Ahmadu Bello University Teaching Hospital at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: witthin 45 minutes of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.