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.: PACTR201904530885595 Date of Approval: 01/04/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomized placebo Controlled Trial comparing the efficacy of rectal diclofenac, EMLA with a placebo in pain control for hysterosalpingography (HSG).
Official scientific title Pain relief for HSG: A Randomized Controlled Trial comparing the effectiveness of rectal Diclofenac, EMLA and Placebo in pain control during hysterosalpingography (HSG).
Brief summary describing the background and objectives of the trial The burden of infertility is high in our environment. The condition constitutes social, emotional, financial and psychological problems to the affected couple. HSG, a first line investigative test carried out on the majority of these women is dreadful and associated with significant anxiety due to pain. These women deserve the right to enjoy the highest attainable standard of physical and mental health including painless procedures. There is no standardized international protocol for HSG pain relief as available evidence is inconclusive regarding the best analgesia for HSG. The study is aimed at comparing the effectiveness of suppository diclofenac (100mg), cervical lidocaine 25mg –prilocaine 25mg cream (5% EMLA) and placebo in pain relief during and after hysterosalpingography procedure.
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 Treatment: Drugs
Anticipated trial start date 14/10/2018
Actual trial start date 04/11/2018
Anticipated date of last follow up 09/03/2019
Actual Last follow-up date 08/03/2019
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rectal diclofenac. 100mg stat 1 hour before the procedure Participants self-administer suppository diclofenac given to them in a sealed numbered opaque envelop according to their randomization. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with prominent anti-inflammatory, analgesic and antipyretic properties. It acts by inhibiting prostaglandin biosynthesis, making it a drug of choice for post-traumatic and post-operative inflammatory conditions. It relieves both spontaneous pain and pain on movement and reduces inflammatory swelling and wound oedema. The suppositories show a rapid onset of absorption with maximum plasma concentration achieved within one hour of administration. 30
Experimental Group EMLA cream 5mg stat 15 minutes before the procedure. Each gram of EMLA contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), and sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and transmission of impulses, thereby achieving local anesthetic action. When 5 to 10 g of the cream is applied to genital mucous membranes between 1 and 75 minutes before surgery (with a median time of 15 minutes), it provides an effective local anesthesia for minor superficial surgical procedures. 30
Control Group Placebo Placebo suppository 1 stat Placebo cream 5mls Placebo suppository 1 hour before procedure. Placebo cream 15 minutes before procedure. Placebo suppositories specially prepared from the same excipient and have the same shape, colour and size with diclofenac suppositories, . Placebo cream Placebo also specially prepared from the same excipient and have same colour and smell with EMLA cream. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All women between the ages of 18 and 49 years undergoing hysterosalpingography as part of their infertility work-up at National Hospital Abuja during the study period. 2. Women already investigated and/or treated for PID. 3. Women with no cervical stenosis or congenital uterine anomaly 1. Non consenting patients. 2. Patients with active pelvic inflammatory disease 3. Patients with history of any allergy to radiopaque dye, local anaesthetics or anti-inflammatory medications. 4. Patients with previous cervical surgery. 5. Patients younger than 18 years or older than 49 years. 6. Patient who took any form of analgesic within 48 hours before presentation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 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 09/11/2018 Health Research Ethics Committee National Hospital Abuja.
Ethics Committee Address
Street address City Postal code Country
Plot 132, Independence Avenue, Central Business District, Abuja. Abuja 900211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the differences in mean pain scores during the procedure in the three groups. Pain score at 4 different stages of the procedure i.e before beginning the procedure, after speculum application, after tenaculum and metal cannula application and at the end of uterine filling
Secondary Outcome The differences in pain scores at 30minutes and 24 hours after the procedure, level of satisfaction and side effects During the procedure, at 30 minutes and 24 hours after the procedure.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hospital Abuja. Plot 132, Independence Avenue, Central Business District. Abuja 900211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
BABANDI Rukayya M Block 6, Mubende Estate, Tamale Street, Zone, Wuse I, Abuja 900211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Hospital Abuja Plot 132, independence avenue, CBD. Abuja 900211 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Chris Agboghoroma Independence Avenue, Central Business District. Abuja 900911 Nigeria
Dr Jimoh Kamaldeen Independence Avenue, Central Business District. Abuja 900911 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rukayya M Babandi rmbabandi@yahoo.com +2348032280518 Bamenda Street, Off Abidjan Street, Zone 3, Wuse.
City Postal code Country Position/Affiliation
Abuja 900283 Nigeria Senior Regitrar National Hospital Abuja
Role Name Email Phone Street address
Scientific Enquiries Chris Agboghoroma agboschris@yahoo.com +2348023342476 Independence Avenue, Central Business District.
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Chief Consultant National Hospital Abuja
Role Name Email Phone Street address
Public Enquiries Rukayya M Babandi rmbabandi@yahoo.com +2348032280518 Bamenda Street, Off Abidjan Street, Zone 3, Wuse.
City Postal code Country Position/Affiliation
Abuja 200283 Nigeria Senior Regitrar National Hospital Abuja
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD collected for the research purpose following de-identification Clinical Study Report,Study Protocol From 8months after publication Open access
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