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.: PACTR201807214613900 Date of Approval: 26/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector spinae plane block
Official scientific title Ultrasound guided Erector Spinae Plane Block for percutaneous radiofrequency ablation of liver tumors
Brief summary describing the background and objectives of the trial Percutaneous radiofrequency ablation (PRFA) is a fundemnetal technique for management of primary and secondary malignant liver tumours.Anaesthesia for PRFA of liver tumours usually involves local anaesthesia and intravenous sedation .However, intraoperative and early postoperative pain is frequently reported by the majority of patients undergoing such procedures .The ultrasound-guided erector spinae plane block (ESPB) is a novel technique that involves local anesthetic injection into the fascial plane deep to the erector spinae (ES) muscle. The aim of the current study is to compare the effects of right ultrasound guided ESPB versus local anesthetic infiltration for pain relief in patients undergoing PRFA of liver tumors.
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: Other
Anticipated trial start date 01/08/2018
Actual trial start date
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date 26/12/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Control Group local anesthetic infiltration once once local anesthetic infiltration along the path of the ablation device will be given 30 Active-Treatment of Control Group
Experimental Group Ultrasound guided erector spinae plane block once once Right ultrasound guided erector spinae plane block is performed with injection of 20 ml bupivacaine 0.25% into the erector spinae plane 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-adult patients -either gender -scheduled for percutaneous radiofrequency ablation of primary or secondary hepatic tumors -patients with a child-pugh score more than B7 -INR more than1.5 -platelet count less than 50000/mm3 -history of mental disorders -allergy to local anesthetics -chest wall deformity -regular use of analgesics 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 80 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 18/03/2018 Research ethics committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain scores up to 24 hours
Secondary Outcome number of patients requiring general anesthesia once
Secondary Outcome postoperative rescue analgesic consumption once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El Geish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta university El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk Abdelkader Mostafa El Geish Tanta 31527 Egypt
Mona Blough El Mourad El Geish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0020402225257 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Mona El Mourad monamorad80@gmail.com 0020402225257 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com 0020403332033 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia and Surgical Intensive Care Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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