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.: PACTR201407000849363 Date of Approval: 03/07/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intravenous fentanyl patient controlled analgesia versus combined transversus abdominis plane and rectus sheath block
Official scientific title Intravenous fentanyl patient controlled analgesia versus combined transversus abdominis plane and rectus sheath block in cirrhotic patients after liver resection
Brief summary describing the background and objectives of the trial Comparison between analgesic efficacy of fentanyl patient controlled analgesia versus combined transeversus abdominis plane and rectus sheath block in cirrhotic patients after liver resection using visual analogue scale for assessment of pain score, in this study we use the local anaethetic bubivacaine in the inserted catheters and measure its level in plasma to avoid its toxicity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cirrhotic patients after liver resection,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2014
Actual trial start date 01/05/2014
Anticipated date of last follow up 01/05/2015
Actual Last follow-up date 01/05/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status 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 Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IVPCA+TAP+RSB 500 mic in 50 ml saline and the dose will be on demand of maximum 90 mic/hr + 1 mg/kg 0.25% bupivacaine in TAP and RSB catheters Every 8 hours for 48 hours Fentanly patient controlled analgesia + Combined surgically assisted Transversus Abdominis Plane block, Rectus Sheath Block (IVPCA+TAP+RSB). 25
Control Group fentanyl patient controlled analgesia 500 mic in 50 ml saline and the dose will be on demand of maximum 90 mic/hr For 48 hours 500 mic in 50 ml saline and the dose will be on demand of maximum 90 mic/hr 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists physical status class II-III. Patients categorized as Child classification ¿A¿ with a Model for End-Stage Liver Disease (MELD) score <10 Modified Moemen Score calculated. If there is any allergy/sensitivity to Local Anaesthetic (LA). Psychatric disease Patients with low Albumin level or had (altered Plasma Protein Binding). Previous surgical scar Patient in need for post-operative ventilation (Malnutrition, Intraoperative complications). Opioid addiction 18 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 01/05/2014 Menoufyia University National Liver Institute (NLI) IRB
Ethics Committee Address
Street address City Postal code Country
Yasin abd elghafar, st SHEBIN el kom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS for pain control after liver resection in cirrhotic patients Every 6 hours posteroperatively for 48 hours
Primary Outcome Total fentanyl consumption For 48 hours postoperatively
Primary Outcome Time for 1st dose rescue analgesic For 48 hours postoperatively
Secondary Outcome nausea and vomiting For 48 hours postoperatively
Secondary Outcome Sedation score For 48 hours postoperatively
Secondary Outcome MELD score and Modified Moemen Score For 48 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the National Liver Institute, Faculty of Medicine, Menoufiya University. Yasin abd elghafar, st Shbin elkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute, Menoufiya University Yasin abd elghafar, st Shbin elkom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute, Menoufiya University Yasin abd elghafar, st Shbin elkom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Helmy Afifi Tanta Tanta Egypt
Khaled Ahmed Yassin Alexandria Alexandria Egypt
Eman hegazy Yasin abd elghafar, st Shbin elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled Yassen kyassen61@hotmail.com 002-01063080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anesthesia and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Eman Hegazy Emanhegazy@windowslive.com 002-01011584753 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Residant of Anaethesia and ICU
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information