Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203697292254 Date of Approval: 03/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of paracervical block for pain relief in women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomized control trial
Official scientific title Effectiveness of paracervical block for pain relief in women undergoing hysterosalpingography in Bayelsa State, South-South Nigeria: a randomized control trial
Brief summary describing the background and objectives of the trial Infertility is defined as the inability to achieve pregnancy after ≥12 months of regular unprotected sexual intercourse. To investigate women with infertility, hysterosalpingography plays a central role. One of the drawbacks of hysterosalpingography is the procedure pain associated with it, which sometimes influences the decision of patients to decline to carry out this investigative modality. This study aims to compare the effectiveness of paracervical block with 2% lignocaine and placebo in pain reduction when undergoing hysterosalpingography. It is a prospective randomized controlled study. This study is conducted at the Departments of Obstetrics and Gynaecology, and Radiology of the two tertiary hospitals in Bayelsa State, Nigeria, over a one-year period. The hospitals are the Federal Medical Centre, Yenagoa and Niger Delta University Teaching Hospital, Okolobiri. The core mandate of these tertiary health institutions revolves around service, training and research, and serve as referral centres for hospitals in Bayelsa State and neighbouring Delta and Rivers States. Three hundred and eighty infertile patients undergoing hysterosalpingography will be included in the study. The inclusion criteria include all women of reproductive age group between 15 and 49 years, and women with primary or secondary infertility. The exclusion criteria include those that declined participation, have an allergy to dye, allergy to lignocaine, pelvic inflammatory disease, cyst on ultrasound scan, and chronic pelvic pain Randomized into two groups: Group I (n = 190) for a paracervical block with 2% lignocaine just before the introduction of the cannula, and Group II (n = 190) for placebo (controls). To access the level of pain, the visual assessment scale and numerical rating scale are being used. The results from this research work will be published in a widely read Journal as it will add to the body of knowledge, and improve patient care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2021
Actual trial start date 09/08/2021
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 380
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Paracervical block before the start of hysterosalpingography With 2 percent lidocaine once A single dose This procedure was carried out in the proliferative phase of the menstrual cycle (between the 7th and 10th day). After selecting the participant for the study, written informed consent was obtained having explained the nature of the study, the procedure and the likely benefits to the patient. Her biodata was obtained at recruitment. Protective lead apron and eyeshield were put on. After passing urine to empty her urinary bladder, the patient was initially placed in the supine position on the X-ray table. The scout radiograph of the antero-posterior view of the pelvis was taken. She was then placed in the lithotomy position, and draped to ensure privacy. With a good light source, a lubricated plastic disposable sterile speculum was inserted into the vagina to expose the cervix. This group (Group I) had paracervical block with 2 percent lidocaine at the 5 and 7 o’ clock positions of the cervix. After hand-washing and putting on sterile gloves, the ecto-cervix was cleaned with savlon solution, and the anterior lip grasped with a tenaculum. The Cohen cannula was inserted into the cervix, and the speculum was removed for the patient’s comfort. The water-based contrast medium (10 – 20 ml) was warmed to body temperature, and injected slowly into the endometrial cavity. Three radiographs to outline the endometrial cavity, fallopian tubes and intraperitoneal spillage were obtained respectively. The cannula was removed, the vulva was cleaned. She was asked to dress up, and observed for two hours before allowing her home. At various points during the procedure, the visual assessment scale was used to assess pain. The numerical pain scale was used to assess pain 20 minutes after the procedure. 190
Control Group Paracervical block with placebo A single dose The procedure is the same as for those in the experimental group, except that in this group (Group II), a paracervical block was given with a placebo. 190 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women of reproductive age group between 15 and 49 years. Women with primary or secondary infertility. Patients that declined participation. Allergy to dye. Allergy to lignocaine. Pelvic inflammatory disease. Cyst on ultrasound scan. Chronic pelvic pain Adult: 19 Year-44 Year 15 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/08/2021 Health Research Ethics Committee Federal Medical Centre Yenagoa
Ethics Committee Address
Street address City Postal code Country
1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 561001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score during and immediately after the procedure. During and after the procedure
Secondary Outcome Difference in pain scores in the two groups During and after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Yenagoa and Niger Delta University Teaching Hospital Okolobiri 1, Hospital Road, Ovom, Yenagoa and Okolobiri community, Bayelsa State. Yenagoa 561001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Peter Chibuzor Oriji Department of Obstetrics and Gynaecology Federal Medical Centre Yenagoa Bayelsa State Nigeria Yenagoa 561001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Federal Medical Centre Yenagoa Yenagoa 561001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 Federal Medical Centre Yenagoa
City Postal code Country Position/Affiliation
Yenagoa 561001 Nigeria Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Public Enquiries Enefia Kelvin Kiridi kiridienefia@gmail.com +2348037249828 Niger Delta University Teaching Hospital Okolobiri
City Postal code Country Position/Affiliation
Yenagoa 561001 Nigeria Consultant Radiologist
Role Name Email Phone Street address
Scientific Enquiries Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 Federal Medical Centre Yenagoa
City Postal code Country Position/Affiliation
Yenagoa 561001 Nigeria Consultant Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The participants' data will be available in the results after data analysis. The study protocol and participants' data that underlie the results reported in this article (text, table, figures and appendices), after de-identification will be available. Data will be available immediately after publication. No end date. Data will be available to anyone who wishes to access it, for any purpose, and indefinitely. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol This research data will be shared immediately after publication. This research will be open access to everyone.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information