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.: PACTR202401895179563 Date of Approval: 15/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analgesic Effect of Erector Spinae Plane Block versus Subcostal Transversus Abdominis Plane Block in Cirrhotic Patients Undergoing Liver Resection Surgery
Official scientific title Analgesic Effect of Erector Spinae Plane Block versus Subcostal Transversus Abdominis Plane Block in Cirrhotic Patients Undergoing Liver Resection Surgery: A Randomized-Controlled Study
Brief summary describing the background and objectives of the trial Liver resection in cirrhotic patients is a major abdominal surgery with challenging pain management due to extended subcostal incision, rib retraction, as well as diaphragmatic and peritoneal irritation which have both visceral and somatic components The objevtives 1- is to assess the analgesic effect of ESP block, Subcostal TAP block and conventional fentanyl analgesia) in cirrhotic patients scheduled for liver resection surgery regarding 2- postoperative pain by visual analogue scale (VAS) 3-time to first request of analgesia postoperative 4- correlation between Analgesia Nociception Index (ANI) measurements and hemodynamic variables (HR, MAP and cardiometry derived variables), 5-post operative complications as postoperative nausea and vomiting (PONV)
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPS TAB
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 01/04/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
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 Plane Block Technique 20 ml 0.25% Bupivacaine+ 4 mg dexamethasone in each side ultrasound guided. once preoperative The patients will be placed in the lateral position, then the skin will be disinfected with 2% chlorhexidine in 70% alcohol, C7 will be detected then we will count down to T5 and a 2- to 5-MHz curved-array ultrasound transducer (SonoSite Edge, Bothell, Washington) will be placed in a longitudinal parasagittal orientation over the transverse processes of T5. The trapezius and erector spinae muscles will be identified superficial to the acoustic shadow of the transverse processes. A 22- gauge, 80-mm block needle (Pajunk, Geisingen, Germany) will be inserted in a cephalad-to-caudal direction until the tip lay on the tip of the transverse process. Fluid, 0.5–1 cm saline, will be injected to confirm correct needle tip position by visualizing spread under erector spinae muscle, then local anesthetic will be injected. The local anesthetic dose will be 20 mL Bupivacaine 0.25% and will add dexamethasone (4mg) .The procedure will repeated following the same steps on the other side 25
Experimental Group Transversus Abdominis plane block Technique 20 ml bupivacaine 0.25% and will add dexamethasone(4mg). once preoperative In supine position after preparing the skin with 2% chlorhexidine solution in 70% alcohol, we will place a high frequency (5–10 MHz) ultrasound probe (SonoSite x- Porte transducer) obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, we gradually move the ultrasound probe laterally along the subcostal margin until we identify the transverses abdominis muscle lying posterior to the rectus muscle. A 22-G Quinck needle will then be introduced medially in the plane of the ultrasound beam and direct towards the transverses abdominis plane. On entering the neuro facial plane, we will give the patients 20 ml bupivacaine 0.25% and will add dexamethasone (4mg). Success of the injection will be confirmed by separation of the rectus abdominis and transversus abdominis with a distinct pocket of local anesthetic in- between. The procedure will be repeated following the same steps on the other side 25
Control Group conventional balanced analgesia preoperative and postoperative according to patient need IV pethidine (50mg) will be given to the patient . 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age: Patients age 18–65 years, of both sexes. 2- Cirrhotic candidates for hepatic resection with Child-Pugh classification (A). 1- Patient refusal to participate in the study. 2- Patients with severe coagulation disorders and those on anticoagulants. 3- Body mass index higher than 40 kg/m2 4- Patients with pacemakers and cardiac arrythmia. 5- Patients with skin infection at puncture site. 6- Patients who are allergic to any of the study drugs, those with opioid addiction. 7- Patients who will develop major intraoperative events (eg, severe hemodynamic instability, massive blood loss and massive blood transfusion. 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 01/02/2023 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessment of pain by visual analogue scale (VAS) Postoperative after patient transportation and stabilization in ICU and after 2,6,12,18 and 24 hours in the ICU
Secondary Outcome time to first request of analgesia, postoperative consumption of additional opioids within the first 24 hours after surgery, correlation between Analgesia Nociception Index (ANI) measurements and hemodynamic variables (HR, MAP and cardiometry derived variables), and any post operative complications as postoperative nausea and vomiting (PONV) . Postoperative after patient transportation and stabilization in ICU and after 2,6,12,18 and 24 hours in the ICU . The following data will be recorded: Total intra operative opioid needed to keep ANI b
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Saied Mohamed Saber Younes hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt assisstent lecture of anasthesia
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
Role Name Email Phone Street address
Scientific Enquiries Eman Saied Mohamed Saber Younes hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend for sharing individual trial participant data ,the study protocol,patient and methods also results to international journal or who will need the data for sientific research Study Protocol when results be available EPS ,block
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia and analgesia journal 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