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.: PACTR202309805784870 Date of Approval: 13/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study Of Nefopam-Dexamethasone And Pethidine-Dexamethasone For Post Caesarean Section Pain Management
Official scientific title Pain Management in Post-Caesarean Sections: Nefopam vs. Pethidine
Brief summary describing the background and objectives of the trial Over the years, there has been an increase in the number of surgical procedures being performed. Many of these procedures are painful and patients increasingly require post-operative analgesia. [1] Caesarean section is both physically and psychologically demanding, with many patients feeling pain and discomfort following the procedure. Pain is a personal experience that is influenced in varying degrees by a combination of biological, psychological, and social factors. [2] Recent research suggests that perioperative glucocorticoids and nefopam have positive effects in the management of surgical pain with minimal or tolerable side effects. [4,5] The aim of this study is to compare the effectiveness of intravenous Nefopam-Dexamethasone with the Pethidine-Dexamethasone combination for post-caesarean section pain management Specific Objectives 1. To evaluate the analgesic effect of intravenous nefopam and dexamethasone for post caesarean pain management. 2. To evaluate the analgesic effect of pethidine and dexamethasone for post caesarean section pain management. 3. To compare the analgesic effect of nefopam-dexamethasone and the pethidine-dexamethasone combinations for post Caesarean section pain management. 4. To compare the total analgesic consumption between both groups within 24hours. 5. To compare the incidence of side effects between the nefopam-dexamethasone and the pethidine-dexamethasone combinations following Caesarean section pain management.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Post Cesearean setion pain
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/08/2020
Actual trial start date 05/08/2020
Anticipated date of last follow up 02/08/2021
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants) 144
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nefopam combined with Dexamethasone 20mg Nefopam plus 8mg Dexamethasone given intravenously 10 minutes The study investigator prepared syringes with drugs ND (labelled A) and drugs PD and put them into sealed envelopes according to the allocation orders. These syringes could not be distinguishable because they contained the same-coloured liquid with the same volume. Another independent anaesthesia resident injected the study drug according to the allocation order. The envelopes were opened by the trained investigator just before the drug injection. Each participant in group (ND) received 8 mg of I.V dexamethasone made up to 2ml, and 20 mg of nefopam (acupan), and those in group (PD) received 100 mg (2ml) of pethidine and 8 mg (2ml) of dexamethasone. The resident who injected the drug was also blinded. The participants in both groups received the study drugs immediately after the clamping of the umbilical cord; then oxytocin 5 IU was given slowly for about 30seconds intravenously, after which 35 IU in 500ml Saline was titrated to effect. Patients’ vital signs were monitored till the end of surgery. In one, five, and ten minutes, APGAR scores were assessed by the paediatrician and recorded Breakthrough pain, during surgery was treated with 100 mg of IV tramadol. Patients with breakthrough pain who required more than 100mg of tramadol were excluded from the study to assess the study drugs' effectiveness. At the end of the surgery, the pain was assessed and recorded and the patient transferred to the Post Anaesthesia Care Unit (PACU). Pain assessment was carried out using the NRS at 0, 15, 30, 60min, 2, 4, 6, and 12 hours after surgery. All pain assessments were carried out at rest and on movement, side effects including nausea and vomiting were documented after surgery and at 1-hour intervals in the Post-Anaesthesia Care Unit for 6 hours. The time of first analgesic request was the time from the administration of study drugs to when the patient first complained of pain and recorded as such. 72
Control Group Pethidine plus Dexamethasone 100mg pethidine plus 8mg Dexamethasone intravenously 10 minutes The study investigator prepared syringes with drugs ND (labelled A) and drugs PD and put them into sealed envelopes according to the allocation orders. These syringes could not be distinguishable because they contained the same-coloured liquid with the same volume. Another independent anaesthesia resident injected the study drug according to the allocation order. The envelopes were opened by the trained investigator just before the drug injection. Each participant in group (ND) received 8 mg of I.V dexamethasone made up to 2ml, and 20 mg of nefopam (acupan), and those in group (PD) received 100 mg (2ml) of pethidine and 8 mg (2ml) of dexamethasone. The resident who injected the drug was also blinded. The participants in both groups received the study drugs immediately after the clamping of the umbilical cord; then oxytocin 5 IU was given slowly for about 30seconds intravenously, after which 35 IU in 500ml Saline was titrated to effect. Patients’ vital signs were monitored till the end of surgery. In one, five, and ten minutes, APGAR scores were assessed by the paediatrician and recorded Breakthrough pain, during surgery was treated with 100 mg of IV tramadol. Patients with breakthrough pain who required more than 100mg of tramadol were excluded from the study to assess the study drugs' effectiveness. At the end of the surgery, the pain was assessed and recorded and the patient transferred to the Post Anaesthesia Care Unit (PACU). Pain assessment was carried out using the NRS at 0, 15, 30, 60min, 2, 4, 6, and 12 hours after surgery. All pain assessments were carried out at rest and on movement, side effects including nausea and vomiting were documented after surgery and at 1-hour intervals in the Post-Anaesthesia Care Unit for 6 hours. The time of first analgesic request was the time from the administration of study drugs to when the patient first complained of pain and recorded as such. 72 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● All ASA II and III patients at term gestation for elective Caesarean section under subarachnoid block. ASA II and III are contradictions to what are labelled as exclusion criteria (PUD, DM and uncontrolled hypertension) . ● Patient’s refusal to give written informed consent. ● Patients with known allergy or sensitivity to the study medication ● Present or past history of peptic ulcer disease ● Contraindications to spinal anaesthesia ● Diabetes mellitus Type 1 or 2 ● Systemic infection, ● Patients with coexisting hepatic, renal, or cardiovascular disease. ● History of chronic pain. ● Opioid use 48hours preceding surgery. ● Antenatal diagnosis of foetal abnormality ● Known IV drug users. ● Glaucoma ● Liver cirrhosis ● Psychiatric illnesses ● Patients on antiviral medications or live vaccines ● Uncontrolled hypertension ● Requiring more than 100mg IV Tramadol for treatment of breakthrough pain Adult: 19 Year-44 Year 19 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 04/08/2020 Ambrose Alli University Ekpoma Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
KM 70 Benin Auchi Expressway Ekpoma 310103 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome for the study was the proportion of patients scoring less than or equal to 3 using the NRS, at 6 and 12 hours after the administration of study drugs 6 and 12 hours after administration od the study drugs
Secondary Outcome a) Time to first analgesic request. The time from administration of study drugs to first analgesic request. b) Comparison of pain scores between the two groups in the first 24 hours postoperatively. c) Comparison of the Total analgesic consumption between the two groups in the first 24 hours postoperatively d) Comparison of Incidences of side effects related to study drugs such as nausea and vomiting and sedation 24 hours after administration of study drugs.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Irrua Specialist Teaching Hospital KM 87 Benin Auchi Expressway Irrua Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded KM 87 Benin Auchi Expressway Irrua Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self KM 87 Benin Auchi Expressway Irrua Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Julian Ojebo Km 87 Benin Auchi Expressway Irrua Nigeria
Dr Ifeanyichukwu Michael Chukwu KM 87 Benin Auchi Expressway Irrua Nigeria
Dr. Peter Ehizokhale Akhideno KM 87 Benin Auchi Expressway Irrua Nigeria
Dr Mercy Oboh KM 87 Benin Auchi Expressway Irrua Nigeria
Dr. Kelvin Salami KM 87 Benin Auchi Expressway Irrua Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Julian Ojebo ojebojulian@gmail.com 09020284145 KM 87 Benin Auchi expressway
City Postal code Country Position/Affiliation
Irrua Nigeria Consultant Anaesthetist at Irrua Specialist Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Christian Igibah igibah@cancad.org 08100267252 KM 87 Benin Auchi expressway
City Postal code Country Position/Affiliation
Irrua Nigeria Research Assistant at Department of Anaesthesia Irrua specialist teaching hospital
Role Name Email Phone Street address
Scientific Enquiries Julian Ojebo ojebojulian@gmail.com 09020284145 KM 87 Benin Auchi Expressway
City Postal code Country Position/Affiliation
Irrua Nigeria Consultant Anaesthetist at Irrua Specialist teaching hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Data Availability: We will make individual participant data, including de-identified datasets, available upon request to qualified researchers, clinicians, and institutions for the purposes of scientific research, verification, and reanalysis. 2. Data Access Committee: To ensure responsible data sharing, we will establish a Data Access Committee (DAC). Researchers interested in accessing our IPD should submit a formal request to the DAC. The DAC will evaluate requests based on scientific merit, ethical considerations, and data protection protocols. 3. Data Protection and Privacy: We are committed to safeguarding the privacy and confidentiality of our study participants. All shared data will be de-identified to prevent re-identification of individual participants. We will comply with applicable data protection regulations and ethics guidelines. 4. Data Sharing Timeline: Data sharing will commence no later than 30th September 2023. This timeline allows us to complete the primary analysis and publish our main findings while giving us adequate time to prepare the data for sharing responsibly. 5. Data Format: IPD will be shared in a suitable, standardized format, which may include spreadsheets or a data repository platform. Detailed data dictionaries and documentation will be provided to assist users in understanding the data. 6. Data Use Agreement: To access the IPD, researchers must sign a Data Use Agreement (DUA). The DUA will outline the terms and conditions of data usage, including restrictions on data sharing, publication, and ethical considerations. 7. Costs: There will be no charge for accessing the IPD. However, we may request reimbursement for costs associated with data preparation and sharing, such as data extraction, formatting, and secure data transfer. For inquiries related to the sharing of individual participant data from this study, please contact: Dr Julian Ojebo ojebojulian@gmail.com Irrua Specialist Teaching Hospital Informed Consent Form 12 months Research Purpose: Access to the IPD should be granted to researchers with a clear and scientifically valid research purpose related to the topic of pain management following Cesarean section surgery. The purpose should align with the objectives of the original study. Qualified Researchers: Access should be limited to qualified researchers, which may include academics, clinicians, and institutions with a demonstrated research background in the relevant field. Applicants should provide evidence of their qualifications and expertise. Ethical Approval: Researchers must provide documentation of ethical approval from their respective ethics committees or institutional review boards for their proposed research using the IPD. Data Protection Compliance: Researchers must demonstrate their ability to comply with data protection regulations and ensure the confidentiality and privacy of the study participants. This includes adherence to relevant data security and privacy standards. Data Use Agreement (DUA): Researchers should be required to sign a Data Use Agreement (DUA) that outlines the terms and conditions of data usage. The DUA should specify how the data will be used, stored, and protected, as well as any restrictions on data sharing and publication. Publication Intent: Researchers should provide information about their intent to publish the results of their analysis using the IPD. This includes details on where and how the research findings will be disseminated. Collaborative Approach: Preference may be given to researchers who express a willingness to collaborate with the original study authors or share their findings with the broader scientific community. Timeline: Researchers should provide a timeline for their research project, including milestones and expected completion dates. This helps ensure that the data is used for research in a timely manner.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information