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.: PACTR202206556144219 Date of Approval: 10/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RECTAL DICLOFENAC VERSUS INTRAMUSCULAR DICLOFENAC FOR POST OPERATIVE ANALGESIA AFTER MYOMECTOMY: A RANDOMISED STUDY
Official scientific title RECTAL DICLOFENAC VERSUS INTRAMUSCULAR DICLOFENAC FOR POST OPERATIVE ANALGESIA AFTER MYOMECTOMY: A RANDOMISED STUDY
Brief summary describing the background and objectives of the trial BACKGROUND: Pain management following myomectomy still remains a challenge in our environment. This is because various drug combinations have been used by different Gynaecologists but there is no gold standard analgesia for post operative pain relief after myomectomy. The use of multimodal approach is central in the management of acute post myomectomy pain. However, the use of two modalities given through intramuscular route increases the number of injection doses, causes more discomfort to the patient and likelihood of complications like injection abscess, injection site reactions and pain with reduced patient’ssatisfaction. It also involves the use of injection devices and requirement of skilled health workers to administer. Rectal diclofenac, on the other hand, could be self- administered,reducing the likelihood of complications from multiple injections from intramuscular combinations and may increase overall patient’s satisfaction. Even though, insertion of rectal diclofenac involves exposure of intimate body part which may be distressing and embarrassing to the patient and though it may cause rectal irritation in some patients, it still merits evaluation for use in managing acute post myomectomy pain.Aim: To determine the effectiveness of rectal diclofenac versus intramuscular diclofenac in reducing post operative pain in the first 24 hours after myomectomy surgeries
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 Post operative pain management following Myomectomy
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/06/2022
Actual trial start date 12/06/2022
Anticipated date of last follow up 06/09/2022
Actual Last follow-up date 11/12/2022
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intramuscular Diclofenac group Intramuscular Diclofenac 75mg 12hourly for 24 hours and Anusol suppository 2 doses 12 hourly for 12 hours 24 hours post operatively at time 0, 6hrs, 12hrs, 18hrs and 24 hours post operatively The intermuscular Diclofenac group will receive intramuscular diclofenac 75mg 12 hourly for 24 hours and Anusol suppository 2 doses 12 hourly for 24 hours. Both groups will receive intramuscular pentazocine 30mg 6 hourly for 24 hours as primary analgesic after myomectomy. Pain will be assessed using a Ten-Point Visual Analogue Scale. Patient’s satisfaction of the mode of the pain relief will beassessed using the Likert scale after 24 hours in the postnatal ward. 45
Control Group Suppository Rectal Diclofenac group 75mg of suppository Rectal Diclofenac 12 hourly for 24 hours and 5mls of intramuscular injection water 12 hourly 24 hours post operatively at time 0, 6hrs, 12hrs, 18hrs and 24hrs following Myomectomy The suppository Rectal Diclofenac group will receive 75 mg of diclofenac suppository 12 hourly for 24 hours and 5mls of intramuscular injection water 12 hourly. Both groups will receive intramuscular pentazocine 30mg 6 hourly for 24 hours as primary analgesic after myomectomy. Pain will be assessed usinga Ten-Point Visual Analogue Scale. Patient’s satisfaction of the mode of the pain relief will beassessed using the Likert scale after 24 hours in the postnatal ward. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants willingness to participate in the study 1. Women that declined consent 2. Women with significant diseases like rectal disorders, peptic ulcer disease, hepatic,hematological and cardiovascular diseases.3. History of chronic pain 4. History of bleeding coagulopathies 5. Use of general anaesthesia 6. Adverse reaction or hypersensitivity to diclofenac or pentazocine Adult: 19 Year-44 Year 18 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 14/07/2021 Alex Ekwueme Federal University Teaching Hospital Abakiliki Nigeria
Ethics Committee Address
Street address City Postal code Country
FMC Road Abakiliki Nigeria Abakiliki 480211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be the pain score assessed using the visual analogue scale. Post operatively at time 0, 6hrs, 12hrs, 18hrs and 24hrs post operatively
Secondary Outcome The secondary outcome measures will be patients’ satisfaction which will be assessed after 24 hours of administration of the drugs, the need and frequency of rescue analgesia and maternal side effects Post operatively 24 hours following Myomectomy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakiliki Nigeria FMC Road Abakiliki Nigeria Abakiliki Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Chiadikobi Irechukwu FMC Road Abakiliki Nigeria Abakiliki Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Chiadikobi John Irechukwu FMC Road Abakiliki Nigeria Abakiliki Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Joseph I. Ikechebelu Nnewi Onitsha road Nnewi Anambra State Nigeria Nnewi Nigeria
Dr Chukwuemeka C. Okoro Nnewi Onitsha road Nnewi Anambra State Nigeria Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Nnewi Onitsha road Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +2348068117444 Nnewi Onitsha road Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Role Name Email Phone Street address
Principal Investigator Chiadikobi Irechukwu irechukwucj@gmail.com +2348030855911 FMC Road Abakiliki Nigeria
City Postal code Country Position/Affiliation
Abakiliki Nigeria Senior Registrar Department of Obstetrics and Gynaecology Alex Ekwueme Federal University Teaching Hospital Abakiliki Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Individual participant data that underlie the results reported in this article, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date. Data are available indefinitely at (Link to be included)
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