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.: PACTR202101816486275 Date of Approval: 26/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector Spinae Block with Opioid Free Anesthesia in cirrhotic patients undergoing hepatic resection: A randomized controlled trial
Official scientific title Erector Spinae Block with Opioid Free Anesthesia in cirrhotic patients undergoing hepatic resection: A randomized controlled trial
Brief summary describing the background and objectives of the trial The erector spinae block constitutes a relatively new truncal block that aims to deposit local anesthetic (LA) between the thoracic transverse process and the erector spinae muscle. The significant advantages of ESP block compared to epidural or paravertebral block relate to the relative ease, simplicity, and safety of the block with fewer risks of pneumothorax. Ultrasound is used to determine the vertebral level of insertion and identify the erector spinae muscle over the transverse process. Opioid Free Anesthesia is multimodal anesthesia associating drugs and/or techniques that allow a good quality general anesthesia with no need for opioids. It’s based on the aim that avoids the negative impact of the intraoperative opioid on patient’s postoperative outcomes and also on the physiology of pathways involved in intraoperative nociception. This study aiming investigate the effect of Erector Spiane block with opioid-free anesthesia in cirrhotic patients scheduled for liver resection on intraoperative and postoperative hemodynamics. The secondary goal to assess the total intra-operative, postoperative fentanyl consumption and postoperative nausea and vomiting in the control group, and time to first request for analgesia according to 10 cm VAS in the study group within 24h after surgery.
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: Drugs
Anticipated trial start date 01/02/2021
Actual trial start date
Anticipated date of last follow up 31/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 Permuted block randomization 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 Erector Spinae Block with Opioid Free Anesthesia the local anesthetic dose will be 20ml Bupivacaine 0.25% on each side with additive Dexmetedomidine ( 0.5 µg/kg ) Once After induction of anesthesia Bilateral Erector Spiane block guided by ultrasound under local anesthesia at the level of thoracic vertebrae (T 7-8). 20
Control Group Conventional balanced anaesthesia and postoperative analgesia According to hemodynamics From start of anesthesia and 24 h postoperative Conventional balanced anaesthesia and postoperative analgesia 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cirrhotic patients candidate for hepatic resection with Child classification (A) -Patients with a pre-existing significant pulmonary disease as moderate to severe pleural effusion and moderate to severe pulmonary hypertension and significant cardiac dysfunction as heart failure and moderate to severe pericardial effusion. - Acute liver failure - Allergy to any of the study drugs - Opioid addiction - Major intraoperative events (e.g. severe hemodynamic instability, massive blood loss, massive blood products transfusion). - Body-mass index is higher than 40 kg/m² - Unwilling to participate in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 15/12/2020 IRB National Liver Institute Menoufia University
Ethics Committee Address
Street address City Postal code Country
Yassin Abdel Ghaffar Street fro mGamal Abdel Nasar Street Shebin Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean Arterial Blood Pressure Continuous intraoperative measurement and 24h postoperative
Primary Outcome Heart rate Continuous intraoperative measurement and 24h postoperative
Secondary Outcome Total fentanyl consumption Intraoperative and Within 24h after surgery
Secondary Outcome Nausea and vomiting During the first 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Inpatient of department of surgery national liver institute Menoufia university Yassen abd elghaffar Sheben Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menna aly mohamed elshafie Yassen abd elghaffar Shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin Abdelghafar street from Gamal Abdel Nasser Street Sheben Elkom Menoufia governorate 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Menna Allah Aly ElShafie Yassin Abdel Ghaffar Street From Gamal Abdel Nassar Street Sheben ElKom 32511 Egypt
Magdy khalil Yassin Abdel Ghaffar Street From Gamal Abdel Nassar Street Sheben ElKom 32511 Egypt
Nagwa ibrahim mwafi Yassin Abdel Ghaffar Street From Gamal Abdel Nassar Street Sheben ElKom 32511 Egypt
CONTACT PEOPLE
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 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Menna elshafie menna80mas@gmail.com 00201112248935 Yassen abd elghaffar
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of anesthesia and Surgical Intensive Care National Liver Institute Menoufia University
Role Name Email Phone Street address
Principal Investigator Magdy Khalil magdykhalil20@yahoo.com 00201001466228 Yassen abd elghaffar
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Professor of anesthesia and Surgical Intensive Care National Liver Institute Menoufia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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