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.: PACTR202206670556358 Date of Approval: 21/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The TraD Trial
Official scientific title Study to assess the feasibility, safety, and effectiveness of high-dose oral tramadol and rectal diclofenac in controlling post-caesarian section pain in women admitted at Nkhata Bay district hospital: protocol for a randomized controlled trial
Brief summary describing the background and objectives of the trial Introduction Post-caesarian section (CS) analgesia has traditionally involved intramuscular Pethidine and diclofenac in Malawi. However, perceived low satisfaction from patients, implementation challenges, and evidence of the effectiveness of high dose tramadol and rectal diclofenac has warranted a need to assess the efficacy, safety, cost-effectiveness, and acceptability of this regimen as a post-CS analgesic protocol at Nkhata Bay District Hospital in comparison to intramuscular Pethidine and diclofenac. Methods A two-arm parallel single-blinded non-inferiority trial involving at least 70 post-operative women will be conducted in the postnatal ward, at Nkhata Bay District Hospital from July to September 2022. The study will include women 18 years or older, without pre-eclampsia, obstetric or surgical complications, ASA III or IV, use of general anesthesia, history of peptic ulcer disease, gastric bleeding, and recent opioid use (within 30 days), renal, liver disease or chronic pain disorders. Intervention (TraD) will involve receiving 100 milligrams of oral tramadol and rectal diclofenac every 8 hours. Control group participants will receive intramuscularly 100mg of Pethidine every 6 hours and 50mg of Diclofenac 8 hourly. The primary outcome will be a change in pain scores at rest and with movement in the first 24 hours. Secondary outcomes will be analgesic sparing measured by the risk of supplemental analgesia, the proportion of reported side effects, and incremental net monitory benefit and satisfaction scores in the first 24 hours.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TraD
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Post-operative Pain
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/07/2022
Actual trial start date
Anticipated date of last follow up 10/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Not yet 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral Tramadol and rectal diclofenac Tramadol 100 milligrams and Diclofenac 50 milligrams 24 hours Patients who will be allocated to the intervention group will, in addition to the above basic procedures, receive 100 milligrams of oral tramadol 8 hourly and rectal diclofenac every 12 hours. Once a participant’s group is revealed, the nurse will admit the patient to the isolation bays of the postnatal ward. These bays are separated from the main bays by a door. Before every administration, the participant’s level of pain and occurrence of any side-effect will be ascertained. Once the intervention is administered, an extra injection will be given at 8 and 24 hours after surgery. These injections will contain a placebo (water for injection) in order to facilitate participant blinding. At 24 hours after surgery, participants will be asked about their level of satisfaction with pain control. 35
Control Group Standard Care Pethidine (100 milligrams) and diclofenac (50 milligrams) every 6 and 8 hours 24 hours Participants in the control group will be given intramuscular Pethidine (100 milligrams) and diclofenac (50 milligrams) every 6 and 8 hours respectively. Before every administration, the participant’s level of pain and occurrence of any side-effect will be ascertained. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years or older, elective or emergency caesarian section without pre-eclampsia, intra-operative or obstetric complications such as post-partum hemorrhage (PPH), surgical infections, ASA III or IV, use of general anesthesia, history of peptic ulcer disease, gastric bleeding, recent opioid use (within 30 days), renal or liver disease, chronic pain disorders or those who refuse consent 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
No 04/07/2022 National Research Council Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Capital Hill, Lilongwe Lilongwe 30377 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in self-reported pain scores at rest 24 hours
Secondary Outcome risk of analgesic supplementation within 24 hours
Secondary Outcome the relative cost-effectiveness of intervention regimens first 24 hours
Secondary Outcome Odds Ratio of drug-related side effects first 24 hours
Secondary Outcome mean difference in patient satisfaction scores 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nkhata Bay District Hospital Along M5 Road, Mkondezi Nkhata Bay P.O. Box Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministry of Health Ministry of Health, Capital Hill Lilongwe 30377 Malawi Public Sector
COLLABORATORS
Name Street address City Postal code Country
Wongani K. Mumba Mkondezi Nkhata Bay Box 4 Malawi
Sibongile Kaphaizi Research Department Lilongwe 30377 Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dumisani Nkhoma dumisaninkhoma7@gmail.com +265888996065 Nkhata Bay District Hospital
City Postal code Country Position/Affiliation
Nkhata Bay Box 4 Malawi Senior Medical Officer Nkhata Bay District Hospital
Role Name Email Phone Street address
Public Enquiries Sibongile Kaphaizi skaphaizi@gmail.com +265998595308 Research Department, Ministry of Health
City Postal code Country Position/Affiliation
Lilongwe 30377 Malawi Research Officer
Role Name Email Phone Street address
Scientific Enquiries Wongani Mumba kangabakako@gmail.com +265998382629 Nkhata Bay District Hospital
City Postal code Country Position/Affiliation
Nkhata Bay Box 4 Malawi Senior Medical Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study data will be kept on a research google drive with backup data on the investigator’s computer with a password. Data will be de-identified by abbreviating names. Data collection tools will be kept in a locked room controlled by the principal investigator at Nkhata District Hospital. Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Data will be available for prospective researchers, upon being granted access by the Nkhata Bay District Health Office Research Committee.
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