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.: PACTR202508818107780 Date of Registration: 14/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post-herniotomy pain relief: caudal block versus a combination of intravenous ketorolac and paracetamol
Official scientific title COMPARISON OF PREINCISIONAL CAUDAL BLOCK AND A COMBINATION OF INTRAVENOUS KETOROLAC AND PARACETAMOL FOR POST-HERNIOTOMY PAIN RELIEF
Brief summary describing the background and objectives of the trial Numerous methods have been employed for post-herniotomy analgesia with varying satisfaction. Caudal block is the technique of choice for post-herniotomy pain relief. Many adjuncts have been added to the local anaesthetics to prolong analgesia. Other comparable options that require less skill to administer and offer multimodal analgesia are being explored. The aim was to compare the analgesic efficacy of caudal block with a combination of intravenous ketorolac and paracetamol on the duration of post-herniotomy analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 12/04/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 08/04/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 88
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Caudal Bupivacaine 0.75ml/kg of 0.25% plain bupivacaine (Astra Zeneca®) Once dosing Stat dose The patients in group C were placed in the left lateral position with the hips and knees flexed. The sacral region was aseptically cleaned with cetrimide and methylated spirit. The sacral hiatus was identified by palpating both sacral cornua and the dimple between the cornua. Using landmark method, a 22G IV cannula was inserted into the caudal space at 60˚ angle to the skin. The cannula was adjusted to 20˚ and advanced not more than 2cm into the caudal space following penetration of the sacrococcygeal membrane. Loss of resistance and a feeling of a ‘click’ (‘give’) indicated penetration of the sacrococcygeal membrane. The stylet was withdrawn. It was aspirated to exclude subarachnoid or intravascular placement of the cannula. Thereafter, 0.75ml/kg of 0.25% plain bupivacaine (Astra Zeneca®) was injected into the caudal space. The cannula was removed and pressure dressing applied at cornual region. 44 Active-Treatment of Control Group
Experimental Group Intravenous Ketorolac plus Paracetamol 1mg/kg Ketorolac plus 15mg/kg Paracetamol infusion Once dosing Stat dose In group Ketorolac-Paracetamol (KP), after the insertion of LMA, IV ketorolac (Dolac-30®, Cadila pharmaceuticals) 1mg/kg and IV paracetamol (Surex®-1g/100ml infusion, Vixa pharmaceutical Co. Ltd) 15mg/kg were administered. The patients were turned to lateral position and pressure dressing was also applied at cornual region to ensure blinding. The patients were returned to the supine position. 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• ASA I or II patients • Age 1 to 8 years • Elective unilateral herniotomy • Parent’s or guardian’s refusal. • Body weight > 25kg. • Septic spots over sacral region. • Sacral bone deformity. • Day cases. • History of bleeding disorders. • Allergy to bupivacaine, ketorolac or paracetamol. • Patients with hepatic or renal disease. • Presence of anal abnormalities. • Co-existing neurological diseases. • Peptic ulcer disease. • Bilateral herniotomy. • History of asthma Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 8 Year(s) Male
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 07/04/2021 University of Benin Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PMB 1111 Benin-Lagos Expressway, Ugbowo Benin city 300283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients scoring either ≤ 5 points (pain-free) if self-reporting or ≤ 4 points (pain-free) if not self-reporting using the Objective Pain Scale at each pain assessment interval will form the primary outcome measure. Post-operative times: 0minute, 15minutes, 30minutes, 45minutes, 60minutes, 2hours, 4 hours, 6hours, 12hours, 24hours
Secondary Outcome Time to first analgesic requirement postoperatively. From the time study drugs were administered after induction of anaesthesia but before surgical incision, until the first post-operative 24hours
Secondary Outcome Mean analgesic consumption in 24 hours postoperatively (in milligrams) at 24hours post-operatively
Secondary Outcome Frequency of Pentazocine dosing in 24 hours postoperatively At 24hours post-operatively
Secondary Outcome Changes in baseline and intraoperative pulse rate, blood pressure, respiratory rate and oxygen saturation (SpO2). Intraoperatively during the anaesthesia and surgery
Secondary Outcome Incidence of complications associated with the use of caudal bupivacaine or intravenous ketorolac and paracetamol such as hypotension, urinary retention, leg weakness and vomiting. 24 hours post-operatively
Secondary Outcome Parental satisfaction of analgesic comfort of the children. 24 hours post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital PMB 1111 Benin-Lagos Road, Ugbowo Benin City 300283 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ifeanyichukwu Michael Chukwu 32A ILLENOTUMA STREET Ekpoma 310101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ifeanyichukwu Michael Chukwu 32A ILLENOTUMA STREET EKPOMA 310101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Nosa Philomena Edomwonyi Department of Anaesthesia, University of Benin Teaching Hospital Benin city 300283 Nigeria
Dr Julan Ojebo Department of Anaesthesia, Garki Hospital Abuja Abuja 900242 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeanyichukwu Chukwu drchukwuifeanyi@gmail.com +2348062278043 32A ILLENOTUMA STREET
City Postal code Country Position/Affiliation
Ekpoma 310101 Nigeria Consultant Anaesthetist Irrua Specialist Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Julian Ojebo ojebojulian@gmail.com +2349020284145 Anaesthesia Department, Garki Hospital Abuja
City Postal code Country Position/Affiliation
Abuja 900242 Nigeria Consultant Anaesthetist and Head of Department of Anaesthesia Garki Hospital Abuja
Role Name Email Phone Street address
Scientific Enquiries Ifeanyichukwu Chukwu drchukwuifeanyi@gmail.com +2348062278043 32A ILLENOTUMA STREET
City Postal code Country Position/Affiliation
Ekpoma 310101 Nigeria Consultant Anaesthetist Irrua Specialist Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? YES. What data in particular will be shared? ALL OF THE INDIVIDUAL PARTICIPANT DATA COLLECTED DURING THE TRIAL, AFTER DEIDENTIFICATION. What other documents will be available? STUDY PROTOCOL, STATISTICAL ANALYSIS PLAN, INFORMED CONSENT FORM, ANALYTIC CODE. When will it be available? IMMEDIATELY AFTER PUBLICATION. NO END DATE With whom? ANYONE WHO WISHES TO ACCESS THE DATA For what type of analyses? ANY PURPOSE. By what mechanism will data be made available? DATA WILL BE AVAILABLE INDEFINITELY AT THE PUBLISHING JOURNAL Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication Principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/08/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 08/08/2025 Result - 08/08/2025
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 14/08/2025 PACTR Admin POST-HERNIOTOMY PAIN RELIEF: CAUDAL BLOCK VERSUS A COMBINATION OF INTRAVENOUS KETOROLAC AND PARACETAMOL Post-herniotomy pain relief: caudal block versus a combination of intravenous ketorolac and paracetamol
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 For clarity Primary Outcome, The proportion of patients scoring either ≤ 5 points (pain-free) if self-reporting or ≤ 4 points (pain-free) if not self-reporting using the Objective Pain Scale at each pain assessment interval will form the primary outcome measure. , 0minute, 15minutes, 30minutes, 45minutes, 60minutes, 2hours, 4 hours, 6hours, 12hours, 24hours Primary Outcome, The proportion of patients scoring either ≤ 5 points (pain-free) if self-reporting or ≤ 4 points (pain-free) if not self-reporting using the Objective Pain Scale at each pain assessment interval will form the primary outcome measure. , Post-operative times: 0minute, 15minutes, 30minutes, 45minutes, 60minutes, 2hours, 4 hours, 6hours, 12hours, 24hours
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 For clarity Secondary Outcome, Time to first analgesic requirement postoperatively. , 0minute, 15minutes, 30minutes, 45minutes, 60minutes, 2hours, 4 hours, 6hours, 12hours, 24hours Secondary Outcome, Time to first analgesic requirement postoperatively. , From the time study drugs were administered after induction of anaesthesia but before surgical incision, until the first post-operative 24hours
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 For clarity Secondary Outcome, Mean analgesic consumption in 24 hours postoperatively (in milligrams), 24hours Secondary Outcome, Mean analgesic consumption in 24 hours postoperatively (in milligrams), at 24hours post-operatively
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 For clarity Secondary Outcome, Frequency of Pentazocine dosing in 24 hours postoperatively, 24hours Secondary Outcome, Frequency of Pentazocine dosing in 24 hours postoperatively, At 24hours post-operatively
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 . Secondary Outcome, Changes in baseline and intraoperative pulse rate, blood pressure, respiratory rate and oxygen saturation (SpO2)., Intraoperatively during the anaesthesia and surgery
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 . Secondary Outcome, Incidence of complications associated with the use of caudal bupivacaine or intravenous ketorolac and paracetamol such as hypotension, urinary retention, leg weakness and vomiting., 24 hours post-operatively
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/08/2025 . Secondary Outcome, Parental satisfaction of analgesic comfort of the children., 24 hours post-operatively
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 08/08/2025 Review comment 35997_25373_1045.pdf 35997_25373_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 2 08/08/2025 Review comment 35997_25373_1046.pdf