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.: PACTR202303663072593 Date of Approval: 22/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative assessment on the effectiveness of paracervical block and rectal diclofenac for pain relief during diagnostic hysteroscopy.
Official scientific title A comparative assessment on the effectiveness of paracervical block and rectal diclofenac for pain relief during diagnostic hysteroscopy.
Brief summary describing the background and objectives of the trial Hysteroscopy a form of endoscopy has relegated blind procedures for the investigation and treatment of intrauterine cavity pathologies and in some instances obviated the need for open surgeries. Hysteroscopy is a fast evolving and invaluable tool in today’s gynaecological care. The cost of procedure, convenience, accuracy and reliability, along with individual acceptability tend to be clearly superior to conventional surgical procedures. As with any surgical procedure, hysteroscopy is also associated with pain which prevents completion of the procedure in some situations. Pain physiology in hysteroscopy as well as a good understanding of anatomy is important in the management of pain during hysteroscopy. The pain of hysteroscopy is a combination of pain due to cervical manipulation, uterine distension and anxiety. Paracervical block is thought to block pain conduction via Frankenhauser’s Plexus, resulting in blockade of conduction causing loss of pain sensation around the area supplied by the nerve hereby decreasing pain. Diclofenac is an NSAID which acts by cyclooxygenase (COX) inhibition and does not discriminate the COX 1 and 2 enzymes. The lack of consensus regarding the ideal pain relief during diagnostic hysteroscopy that would be effective and tolerable by the women, informed the need for this work. This study will be aimed at determining the efficacy of paracervical block versus rectal diclofenac for pain relief during diagnostic hysteroscopy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied No
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2023
Actual trial start date 03/04/2023
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date 24/07/2024
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Paracervical block group Each participant will receive paracervical block with 20 millilitres of 1% xylocaine. Stat dose PCB will be performed by researcher, research assistants or supervising consultants with 18G cannula needle on a 20ml syringe using a standard dose of 200 mg (20 ml) of 1% Lidocaine per participant. To perform the PCB, cervix and vagina will be cleaned with dilute chlorhexidine solution and a sterile Cusco speculum introduced into the vagina to expose the cervix. Two (2) ml of 1% lignocaine will be injected at 120 clock position of the cervix to a depth of 1.5 to 3 cm. The anterior lip of the cervix will be grasped at the injection site with a Volsellum forceps and a gentle traction applied downwards to stabilize it. Five (5) ml of 1% lidocaine will be injected into cervico-vaginal junction a depth of 1.5-3 cm at 4 and 8 0clock positions32, care being taken to aspirate before injection to avoid intravascular injection. A latency period of about 5 minutes will be allowed before the procedure is commenced to allow for onset of action of the agent. 50 Active-Treatment of Control Group
Experimental Group Rectal Diclofenac group Each of the participants will be given 200mg of rectal diclofenac before diagnostic hysterescopy. Stat dose Diclofenac sodium will be inserted rectally into the rectum by the researcher or research assistants using double gloved index and middle fingers with participants in Sim’s position, a general dose of 200 mg will be used. A latency period of about 30 minutes will be allowed before the hysteroscopy is commenced to give room for the onset of analgesic action of the drug. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women undergoing diagnostic hysteroscopy and gave consent for the study 1.Women who are allergic to lignocaine/diclofenac 2.Women who had failed attempts at previous hysteroscopy 3.Women with cervicitis or active pelvic inflammatory disease Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 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 26/12/2022 Health Research Ethics Committee University of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu 40001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome, measured the mean pain scores in the participants who will receive rectal diclofenac or PCB during diagnostic hysteroscopy 30 minutes after either the paracervical block or rectal diclofenac insertion
Secondary Outcome 1.patient satisfaction 2.Side effects during diagnostic hysteroscopy 30 minutes after either the paracervical block or rectal diclofenac insertion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 40001 Nigeria
Blessed Assurance Specialist Hospital Awkinanaw Enugu 400106 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Duru Victor Ituku-Ozalla Enugu 40001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Duru Victor Chinazom UNTH Enugu 40001 Nigeria Individual
Secondary Sponsor Ezegwui Hyginus Uzo UNTH Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victor Duru duvic27@gmail.com +2348033947328 UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Hyginus Ezegwui hyginus.ezegwui@unn.edu.ng +2347030489009 UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 UNTH
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Reader
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics and Gynaecology. Data or samples shared will be coded with the personal identification excluded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 2 years. Extension can be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a study protocol,Statistical Analysis Plan ,informed consent form and clinical study report. For more information or to submit a request, please contact pactradmin@mrc.ac.za.
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