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.: PACTR202001875909224 Date of Approval: 13/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Study between Epidural analgesia Versus subcutaneous nalbuphen For Postoperative Analgesia After Abdominal Surgeries.
Official scientific title Comparative Study between Epidural analgesia Versus subcutaneous nalbuphen For Postoperative Analgesia After Abdominal Surgeries.
Brief summary describing the background and objectives of the trial To provide effective pain relief for the patients undergoing surgery is one of the major goals of postoperative management. It is desirous to have medicines that provide effective pain relief with minimal side effects. Several medicines that can be administered by different routes are available for the management of pain during postoperative period Epidural and spinal blocks are two major regional techniques with a long history of effective use for a variety of surgical procedures and pain relief. Opioid analgesics are often used for the management of moderate-to-severe type of pain
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 Compare between Epidural analgesia Versus subcutaneous nalbuphen For Postoperative Analgesia
Anticipated trial start date 19/12/2019
Actual trial start date 19/12/2019
Anticipated date of last follow up 09/01/2020
Actual Last follow-up date 01/03/2020
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 130
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group epidural analgesia group (A) an induction dose of 18ml of bupivacaine 0.25% + 2ml fentanyl (100 Mcg) was injected in epidural catheter, top up dose 6 ml of solution followed for 24hour group (A) an induction dose of 18ml of bupivacaine 0.25% + 2ml fentanyl (100 Mcg) was injected in epidural catheter .Postoperatively, all patients were scheduled for analgesics ( paracetamol and ketorolac). The patients were evaluated for pain scores 65 Active-Treatment of Control Group
Experimental Group subcutaneous nalbuphen subcutaneous nalbuphine (0.15mg/kg) was injected and top up dose 0.05 SC nalbuphine followed for 24hour subcutaneous nalbuphen (0.15mg/kg) was injected and top up dose 0.05 SC nalbuphine.Postoperatively, all patients were scheduled for analgesics ( paracetamol and ketorolac). The patients were evaluated for pain scores 65
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
the American Society of Anesthesiologists physical status class I and II undergoing elective surgeries physical dependence to opioids; hepatic and renal disease; who were pregnant and lactating, elderly, diabetes, asthma, epilepsy, bleeding disorder, receiving central nervous system depressants, established respiratory depression; a history of hypersensitivity to study drugs; not willing to participate in the study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
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 15/12/2019 Eithical Committee.Department of anesthesiology. intensive care and pain management. faculty of medicine . menofia university
Ethics Committee Address
Street address City Postal code Country
shebin elkom shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the time of first call of analgesia from the end of the surgery.for 24hour postoperative
Secondary Outcome The amount of analgesics used in the first 24 postoperative hours, Intraoperative need of analgesics,VAS , all the patients were also evaluated for any complications and their satisfaction intraoperative and postoperative up to 24hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine . menofia university shebin elkom shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Noha abd allah elsayed afify shebin elkom shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine. menofia university shebin elkom shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Noha abd allah elsayed afify shebin elkom shebin elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 shebin elkom
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes اقر انا اننى موافق على استخدام تسكين فوق الجافية مقابل حقن عقار النالوفين تحت الجلد من أجل تسكين الام ما بعد الجراحة بعد العمليات الجراحية في البطن. وتم توضيح الاثار الجانبيه المتعلقه سواء بهذا الحقن اوالمواد المستخدمه وتم ايضاح هذا دون اجهام منى بذلك. المقر بما فيه Patient name: I agree to use epidural analgesia or subcutaneous nalbuphen For Postoperative Analgesia After Abdominal Surgeries as a supplement to general anesthesia, and the side effects related to this injection or the materials used have been clarified and this has been clarified without me being tempted to do so. Signature : Study Protocol within two months controlled access
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