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.: PACTR202405780450172 Date of Approval: 14/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transdermal diclofenac patch versus intramuscular pentazocine for postoperative analgesia in caesarean section at Nnamdi Azikiwe University Hospital Nnewi, Nigeria: a randomized control trial
Official scientific title Transdermal diclofenac patch versus intramuscular pentazocine for postoperative analgesia in caesarean section at Nnamdi Azikiwe University Hospital Nnewi, Nigeria: a randomized control trial
Brief summary describing the background and objectives of the trial Background: Pain is one of the debilitating events in the postoperative period after caesarean section, as such, optimal postoperative analgesia is required to make the event a tolerable and satisfying experience. Two major groups of analgesics are commonly employed to that purpose, the opioids and the non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac is one of the commonly used NSAIDs and can be delivered through several routes including the oral, rectal and topical (patch, cream) routes. The use of the diclofenac patch has not been extensively studied despite obvious advantages which include offering adequate analgesia in the postoperative period, and elimination of some of the side effects known to be associated with other routes of diclofenac administration and the traditional opioids like pentazocine. There is a paucity of studies directly comparing the analgesic effects of diclofenac patch as against intramuscular pentazocine. Objective: To compare the effectiveness of transdermal diclofenac patch and intramuscular pentazocine in providing postoperative analgesia after caesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
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 31/10/2021
Actual trial start date 01/01/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 126
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 IM pentazocine group A dose of intramuscular pentazocine 30mg was given every 4 hours and the placebo patch applied every 12 hours 48 hours A dose of intramuscular pentazocine 30mg was given every 4 hours and the placebo patch applied every 12 hour 63 Active-Treatment of Control Group
Experimental Group Transdermal diclofenac group A transdermal diclofenac patch 140mg was applied to the anterior abdominal wall about 5cm from the operation site dressing at the midline, this was changed every 12 hours with intramuscular injection of 1ml of water for injection every 4 hours 48 hours A transdermal diclofenac patch 140mg was applied to the anterior abdominal wall about 5cm from the operation site dressing at the midline, this was changed every 12 hours with intramuscular injection of 1ml of water for injection every 4 hours 63
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting women for lower segment caesarean section under spinal anaesthesia Those excluded include women with American Society of Anaesthesiologists (ASA) grade level > iii, duration of surgery beyond 90 minutes, failed spinal anaesthesia, previous allergy to NSAIDS, bronchial asthma, history of sickle cell disease, preterm gestation, unconscious state, and history of peptic ulcer Adult: 19 Year-44 Year 19 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 26/10/2021 Nnamdi Azikiwe University Teaching Hospital Ethics and Research C ommittee
Ethics Committee Address
Street address City Postal code Country
Nnewi IBETO Rd Nnewi NNEWI 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measure was mean visual analogue pain score. Pain assessment using VAS at 2nd, 6th, 10th, 16th, 24th and 48th hours post CS
Secondary Outcome Secondary outcome measures included patient need for rescue analgesia, maternal side effect profile, patient satisfaction and timing of initiation of breastfeeding. Paiin assessment using VAS at the 2nd, 6th, 10th, 16th, 24th and 48th hours post
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital 10 Nnewi road nnewi Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR Osuafor 10 Nnewi IBETO Rd Nnewi Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Osuafor Ugochukwu Harrison 10 Nnewi IBETO Rd Nnewi Nnewi 435101 Nigeria Individual
Secondary Sponsor dDr Anikwe Chidebe Christian 10 Nnewi IBETO Rd Nnewi Nnewi 435101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Anikwe Chidebe C 10 Nnewi IBETO Rd Nnewi Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ugochukwu H Osuafor ugochukwuosuafor@gmail.com 08035841986 10 Nnewi IBETO Rd Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Chidebe C Anikwe drchideanikwechristian@gmail.com 08064165965 10 Nnewi IBETO Nnewi
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Ugochukwu H Osuafor ugochukwuosuafor@gmail.com 08035841986 10 Nnewi IBETO Nnewi
City Postal code Country Position/Affiliation
nnewi 435101 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result reported in the article after deidentification ( text , tables,figures) Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months to end at 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/05/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 01/05/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information