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.: PACTR202205816144149 Date of Approval: 23/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RECTAL DICLOFENAC VERSUS PARACERVICAL BLOCK FOR PAIN RELIEF DURING MANUAL VACUUM ASPIRATION: AN OPEN-LABEL RANDOMISED TRIAL
Official scientific title RECTAL DICLOFENAC VERSUS PARACERVICAL BLOCK FOR PAIN RELIEF DURING MANUAL VACUUM ASPIRATION: AN OPEN-LABEL RANDOMISED TRIAL
Brief summary describing the background and objectives of the trial This shall be a hospital-based open-label randomised trial where eighty-four patients with a missed miscarriage, incomplete miscarriage or anembryonic gestation (who satisfy the inclusion criteria and elect to have manual vacuum aspiration performed on them) would be recruited as they are seen in the gynaecological emergency unit. Forty-two patients in each group shall be randomly assigned to receive either 100 mg of rectal diclofenac (Group A) or 10 ml of 1% plain lignocaine (100 mg) for para-cervical block (Group B) as pain control. Their demographic data and clinical parameters such as age and parity, as well as other parameters such as pain perception (on a scale of 0 to 10) at application of the tenaculum forceps at the anterior lip of the cervix, during cervical dilatation (where indicated) and during the evacuation, shall be collected and recorded into a proforma. Degree of satisfaction with the assigned analgesic option on a scale of 1 to 5 would also be collated. The primary outcome measure shall be the mean pain scores for the two forms of analgesics and the secondary outcome measure shall be the patient satisfaction with the assigned analgesic, and the side effect profile of each agent
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2022
Actual trial start date 01/10/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 84
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 Rectal diclofenac 100 mg Single dose Analgesic for manual vacuum aspiration 42 Active-Treatment of Control Group
Experimental Group Plain lignocaine 10 ml of 1% (100 mg) Single dose Para-cervical block as analgesic during manual vacuum aspiration 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Missed miscarriage Incomplete miscarriage Anembryonic gestation Septic miscarriage Hemodynamic instability Allergy to lignocaine Allergy to diclofenac Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 45 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 13/09/2021 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Center Birnin Kebbi Birnin Kebbi 860101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Median pain scores for the two forms of analgesics 5 minutes after completion of the procedure
Secondary Outcome Patient Satisfaction with assigned analgesic Side effect profile of each analgesic agent 30 minutes after completion of the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Center Birnin Kebbi Nigeria FMC/Dukku Barracks Road Birnin Kebbi 860101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obiokonkwo Augustus Chimezie FMC/Dukku Barracks Road Birnin Kebbi 860101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obiokonkwo Augustus Chimezie FMC/Dukku Barracks Road Birnin Kebbi 860101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Aisha Nana Adamu FMC/Dukku Barracks Road Birnin Kebbi 860101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Augustus Chimezie Obiokonkwo macchimei@yahoo.com +2348180439189 FMC/Dukku Barracks Road
City Postal code Country Position/Affiliation
Birnin Kebbi 860101 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Augustus Chimezie Obiokonkwo macchimei@yahoo.com +2348180439189 FMC/Dukku Barracks Road
City Postal code Country Position/Affiliation
Birnin Kebbi 860101 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Augustus Chimezie Obiokonkwo macchimei@yahoo.com +2348180439189 FMC/Dukku Barracks Road
City Postal code Country Position/Affiliation
Birnin Kebbi 860101 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Open
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