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.: PACTR202208575341765 Date of Approval: 23/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and Efficacy of Adding Nalbuphine to Bupivacaine in Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery: A Randomised Controlled Trial.
Official scientific title Efficacy of Nalbuphine in TAP Block
Brief summary describing the background and objectives of the trial Bariatric surgery is increasing, analgesia is an integral part of anesthetic practice, TAP block provides adequate analgesia; however for limited time. we expect that addition of nalbuphine will prolong and improve the analgesic profile To determine the effects of nalbuphine addition to bupivacaine on the analgesic profile.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2022
Actual trial start date 01/04/2023
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants)
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group TAP block with plain bupivacaine • Group C (control; only bupivacaine): patients will receive 20 ml 0.25% bupivacaine to produce TAP block. 24 hours postoperative • Group C (control; only bupivacaine): patients will receive 20 ml 0.25% bupivacaine to produce TAP block. 19 Active-Treatment of Control Group
Experimental Group TAP block with bupivacaine with nalbuphine • Patients will receive 20 ml of 0.25% bupivacaine with nalbuphine 0.1mg per kg to produce TAP block. • Group N (nalbuphine/bupivacaine): patients will receive 20 ml of 0.25% bupivacaine with nalbuphine 0.1mg per kg to produce TAP block, done once only and followed for 24 hours postoperative. • Group N (nalbuphine/bupivacaine): patients will receive 20 ml of 0.25% bupivacaine with nalbuphine 0.1mg per kg to produce TAP block. 19
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Obese patients with BMI ≥ 35 kg/m2 Obese patients aged between 19 and 65 years of age Elective laparoscopic bariatric surgery. American Society of Anesthesiology physical status II and III Known allergy to nalbuphine and/or Bupivacaine Chronic opioid users Chronic pain conditions (consuming regular analgesics > 3 months) History of neurological diseases Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 20/02/2022 Cairo University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1st Kasralainy Street, Almanial Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to first full ambulation 2 hours, 4, hours, 6 hours, 8 hours, 12 hours
Secondary Outcome a. Hemodynamic monitoring every 10 minutes intraoperative, every 2 hours postoperative till 24 hours
Secondary Outcome b. First time to request analgesic post-operative hourly till 24 hours postoperative
Secondary Outcome d. Visual analogue score (VAS) every 2 hours till 24 hours postoperative
Secondary Outcome e. Total opioid consumption every 4 hours till 24 hours postoperative
Secondary Outcome g. Time of hospital stay. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals 1st Kasralainy Street, Almanial Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ATEF KAMEL 7th district Maadi Cairo 11534 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals 1st Kasralainy street, Almanial Cairo 11562 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Kamel atef.kamel@kasralainy.edu.eg +201001155851 7th district, Cairo-Swiess road
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of anaesthesia Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Mahmoud mohamed_mahmoud@kasralainy.edu.eg +201003714635 7th district, maadi
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hala Amer halaamer1@hotmail.com +201004972691 Ahram Street
City Postal code Country Position/Affiliation
Giza Egypt Master degree in anaesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data IPD collected during this trial will be available and will be shared. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication, no end date. researchers who provide a sound methodology
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