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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609467782861 Date of Registration: 07/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of double versus triple analgesia on post-caesarean pain relief at Rivers State University Teaching Hospital
Official scientific title Effect of double versus triple analgesia on post-caesarean pain relief at Rivers State University Teaching Hospital
Brief summary describing the background and objectives of the trial Background Caesarean section remains one of the most frequently performed surgical procedures worldwide and constitutes a major component of modern obstetric practice. Although advances in surgical techniques, anaesthesia and perioperative care have significantly improved maternal outcomes and postoperative pain following caesarean delivery remains a major challenge. Effective post-caesarean analgesia facilitates early ambulation, promotes maternal-infant bonding, enhances breastfeeding success, reduces postoperative complications and improves maternal satisfaction. Conversely, inadequate pain control may delay recovery, impair neonatal care, prolong hospital stay, increase complication risks and healthcare costs. Multimodal analgesia, involving the combination of analgesics with different mechanisms of action, has become the recommended approach for postoperative pain management. At the Rivers State University Teaching Hospital, a combination of rectal diclofenac and intramuscular pentazocine is commonly employed for post-caesarean pain relief. However, some clinicians additionally administer intramuscular paracetamol as part of a triple-agent analgesic regimen. Despite the widespread use of both regimens, there is limited evidence within the local environment regarding their comparative effectiveness. SPECIFIC OBJECTIVES 1. To compare the mean postoperative pain scores among women receiving double-agent analgesia (rectal diclofenac and intramuscular pentazocine) and those receiving triple-agent analgesia (rectal diclofenac, intramuscular pentazocine and intramuscular paracetamol) following caesarean section. 2. To compare the proportion of women requiring rescue (additional) analgesia in double-agent versus triple-agent groups. 3. To compare maternal satisfaction with postoperative pain management between the two groups. 4. To compare postoperative recovery outcomes, including time to ambulation and duration of hospital stay, between the two groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DVTA
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2026
Actual trial start date 01/10/2026
Anticipated date of last follow up 31/03/2027
Actual Last follow-up date 31/03/2027
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rectal diclofenac intramuscular pentazocine and intramuscular paracetamol rectal diclofenac 100 mg, intramuscular pentazocine 30 mg and intramuscular paracetamol 600 mg STAT DOSES Participants allocated to the triple-agent analgesia group will receive rectal diclofenac 100 mg, intramuscular pentazocine 30 mg and intramuscular paracetamol 600 mg according to the study protocol. 50
Control Group Rectal diclofenac intramuscular pentazocine and placebo Rectal diclofenac 100 mg and intramuscular pentazocine 30 mg and Sterile water for injection STAT DOSES Participants allocated to the double-agent analgesia group will receive rectal diclofenac 100 mg and intramuscular pentazocine 30 mg according to the departmental postoperative analgesia protocol. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with live singleton pregnancies beyond the age of viability undergoing elective or emergency caesarean section. 1. Women with known hypersensitivity or contraindication to diclofenac, pentazocine, paracetamol, or any component of the study medications. 2. Women with significant medical disorders such as severe hepatic, renal, cardiovascular, or respiratory disease. 3. Women who develop major intraoperative or immediate postoperative complications, including postpartum haemorrhage or need for re-laparotomy. 4. Women who did not consent to the study. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 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 13/08/2026 RIVERS STATE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
6-8 Harley Street, Old GRA Port Harcourt 500241 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score in the two groups (double agent vs triple agent) At 6, 12, 18, and 24 hours following caesarean section
Secondary Outcome • Need for rescue analgesia • Interval for rescue analgesia • Frequency of rescue analgesia • Time to first ambulation • Duration of postoperative hospital stay. • Maternal satisfaction At 6, 12, 18, and 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
RIVERS STATE UNIVERSITY TEACHING HOSPITAL 6-8 Harley Street, Old GRA Port Harcourt 500241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Martin nde 62 Stadium road Port Harcourt 500101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Martin Nde 62 Stadium Road Port Harcourt 500102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Martin Nde martnde@gmail.com +2348063661668 62 Stadium road
City Postal code Country Position/Affiliation
Port Harcourt 500102 Nigeria Senior Resident Doctor Obsterics and Gynaecology Rivers State University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Esther Nonye Enyidah hernsi@yahoo.com +2348033410619 6-8 Harley Street, Old GRA
City Postal code Country Position/Affiliation
Port Harcourt 500241 Nigeria Consultant Obstetrician and Gynaecologist Rivers State University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Simeon Amadi amachijio@yahoo.com +2348060203587 6-8 Harley Street, Old GRA
City Postal code Country Position/Affiliation
Port Harcourt 500241 Nigeria Consultant Obstetrician and Gynaecologist Rivers State University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Martin Nde martnde@gmail.com +2348063661668 62 Stadium road
City Postal code Country Position/Affiliation
Port Harcourt 500101 Nigeria Senior Registrar Obstetrics and Gynaecology Rivers State University Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Ethical clearance from the ethics committee has been secured . Information and raw data which are anonymous and not containing identifiers can be shared with researchers and the scientific community when needed Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 Months Open systematic reviews and meta analysis. Researchers that have passed ethics course on good clinical practice.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 07/09/2026 PACTR Admin EFFECT OF DOUBLE VERSUS TRIPLE ANALGESIA ON POST-CAESAREAN PAIN RELIEF AT RIVERS STATE UNIVERSITY TEACHING HOSPITAL Effect of double versus triple analgesia on post-caesarean pain relief at Rivers State University Teaching Hospital
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 07/09/2026 PACTR Admin EFFECT OF DOUBLE VERSUS TRIPLE ANALGESIA ON POST-CAESAREAN PAIN RELIEF AT RIVERS STATE UNIVERSITY TEACHING HOSPITAL Effect of double versus triple analgesia on post-caesarean pain relief at Rivers State University Teaching Hospital