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.: PACTR202109777479068 Date of Approval: 08/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A prospective non-inferiority study of Different bupivacaine concentrations in Erector spinae plane block during hepatic tumor ablation
Official scientific title A prospective non-inferiority study of Different bupivacaine concentrations in Erector spinae plane block during hepatic tumor ablation
Brief summary describing the background and objectives of the trial Percutaneous radiofrequency ablation (PRFA) has been gaining importance in recent years as the mainstay of management, at most centers, for patients with primary and secondary malignant liver tumors. Anesthesia for PRFA of liver tumors usually involves local anesthesia 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) initially described by Forero et al. 4, is an interfascial plane block with deposition of local anesthetic solution at the tip of the transverse process deep to the erector spinae (ES) muscle. Injecting the local anesthetic solution at the level of the T5 transverse process has been associated with spread of the injectate between the C7 and T8 vertebral levels. ESPB can thus provide thoracic analgesia. The analgesic efficacy of the ESPB has been proven in various thoracic and abdominal procedures. Interestingly, ESPB has been effectively used for analgesia after PRFA of hepatic tumors using a mixture of 0.5% bupivacaine and 2% lidocaine. Because most of patients undergoing liver tumor ablation suffers a considerable degree of liver function impairment, it is thought that lower dose of LA would be safer to avoid relevant side effects and possible complications. The aim of the current study is to compare different concentrations of Bupivacaine used in ESPB 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 Prevention
Anticipated trial start date 15/09/2021
Actual trial start date 15/09/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group L 20 ml of bupivacaine 0.25% 24 hours after the procedure Regional techniques will be implemented under aseptic conditions, patients will be initially placed in the sitting position and the spinous process of T7 is located. A high-frequency linear array probe will be placed in a longitudinal orientation adjacent to the spinous process, and then the probe will be moved laterally to visualize the anatomical landmarks including the T7 transverse process with the overlying trapezius and erector spinae muscles. A 22 G needle subsequently introduced in plane through the skin and subcutaneous tissue and advanced with the aid of ultrasound guidance till it came in contact with T7 transverse process, followed by injection of 20 ml of bupivacaine 0.25% according to the study group. 25
Control Group Grup C 20 ml of bupivacaine 0.5% 24 hours after the procedure Regional techniques will be implemented under aseptic conditions, patients were initially placed in the sitting position and the spinous process of T7 is located. A high-frequency linear array probe (6–12 MHz – Xario™ 200, Toshipa, Japan) will be placed in a longitudinal orientation adjacent to the spinous process, and then the probe will be moved laterally to visualize the anatomical landmarks including the T7 transverse process with the overlying trapezius and erector spinae muscles. The skin is then infiltrated with 3 ml lidocaine 2% and a 50 mm, 22 G needle subsequently introduced in plane through the skin and subcutaneous tissue and advanced with the aid of ultrasound guidance till it came in contact with T7 transverse process. Accurate placement of the needle tip deep to the erector spinae muscles was verified by injecting 0.5–1 ml saline 0.9% while observing the injectate separating the erector spinae muscles from the transverse process with a satisfactory caudal and cephalic extension. Negative aspiration of blood will be assured, followed by injection of 20 ml of bupivacaine 0.5% according to the study group. patients will be instructed to rest in a supine position to allow percutaneous infiltration of either 10 ml of a local anesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.5%) along the track of insertion of the ablative device. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients, of either gender, with a Child-Pugh score not more than B and scheduled for ultrasound-guided PRFA of primary or secondary hepatic tumors a single focal hepatic lesion will be enrolled in the study. Patients with an INR value exceeding 1.5, platelet count less than 50,000/mm3, body mass index (BMI)>35, history of mental disorders or psychiatric illness, those with chronic pain or on regular remedies of analgesics, allergy to local anesthetics and spine deformity will be excluded from the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 22/08/2021 Institutional review board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 22555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-procedural pain at 30 min, 1, 2, 4, 8, 12, 18 and 24 h after the procedure
Secondary Outcome analgesic consumption first day after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospitals Elgomhoreya Mansoura 22555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Elgomhoreya Mansoura 22555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhoareya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator lrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor of anesthesia
Role Name Email Phone Street address
Public Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Alrefaey alrefaey refa3ey2@yahoo.com +201064203475 Geihan street
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes researchers intend to share the study protocol, statistical plan, clinical study report Clinical Study Report,Statistical Analysis Plan,Study Protocol within 12 months after completion of the study any researcher or institution covered by ethical committee
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