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.: PACTR202109527452994 Date of Approval: 08/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between Ultrasound-Guided Erector Spinae Plane Block and Thoracic Paravertebral Block for Postoperative Analgesia after Video-Assisted Thoracic Surgery; An Equivalance Study
Official scientific title Comparative Study between Ultrasound-Guided Erector Spinae Plane Block and Thoracic Paravertebral Block for Postoperative Analgesia after Video-Assisted Thoracic Surgery; An Equivalance Study
Brief summary describing the background and objectives of the trial Video-assisted thoracoscopic surgery (VATS) is a commonly performed minimally invasive procedure that has led to lower levels of pain. However, VATS require analgesia that blocks both visceral and somatic nerve fibers for more effective pain control. Postoperative pain management is becoming an integral part of anesthesia care. Optimal pain control in patients undergoing VATS is imperative for good rehabilitation and functional outcomes. Current modalities in use aims at reducing postoperative opioid consumption to control postoperative pain thus minimizing its complications in what is recently known as multimodal analgesia techniques. As a result, newer pain control modalities have been used providing adequate pain relief and not affecting muscle strength. Thoracic paravertebral block (TPVB) was introduced as an excellent solution for multimodal analgesia peri-operatively. In this study we will compare the analgesic efficacies of erector spinae plane block (ESPB) and TPVB after VATS and postoperative morphine requirement.
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 01/05/2021
Actual trial start date 01/06/2021
Anticipated date of last follow up 30/05/2022
Actual Last follow-up date 30/05/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL https://doi.org/10.1186/s42077-023-00339-1
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group thoracic paravertebral group 20 mL of 0.25% bupivacaine will be administered for block performance for intera and postoperative period A high-frequency linear ultrasound probe covered with sterile sheath (Sonoscape® SSI 6000, China with 12 6 MHz high frequency linear probe) will be placed in a vertical orientation 2–3 cm lateral to the midline. Once the transverse process, internal intercostal membrane and parietal pleura identified, A 22g 100 mm needle (B- Braun Medical Inc., Bethlehem, PA, USA) will be inserted after standard skin disinfection and infiltration of lidocaine 2% subcutaneously laterally to medically Use a sterile probe cover until the tip lay in the thoracic paravertebral space beyond the internal intercostal membrane. After injection with normal saline, to confirm ventral pressing of the parietal pleura, 20 mL of 0.25% bupivacaine will be administered for block performance 40 Active-Treatment of Control Group
Experimental Group erector spinae plane block 20 milliliters (mL) of 0.25% bupivacaine will be administered for block performance intra and post operative period A high-frequency linear ultrasound probe covered with sterile sheath (Sonoscape® SSI 6000, China with 12 6 MHz high frequency linear probe) will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified A 22g 100 mm needle (B- Braun Medical Inc., Bethlehem, PA, USA) will be inserted after standard skin disinfection and infiltration of lidocaine 2% subcutaneously in a caudad-to-cephalad direction using a sterile probe cover until the tip lay in the interfacial plane deep to the erector spinae muscle. After hydrolocalization with normal saline, this plane will be opened. 20 milliliters (mL) of 0.25% bupivacaine will be administered for block performance 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- 18 years or older of either sex. 2- Patients with American Society of Anesthesiologists (ASA) physical status 1–2 who will be scheduled for video assisted thoracic surgery. 1- History of allergy to the medications used in the study. 2- Contraindication to regional anesthesia (including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection). 3- Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2). 4- Renal dysfunction (GFR < 50ml/min). 5- Psychiatric disorder. 6- Pregnancy. 7- Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2. 8- VATS procedure converted to open. 9- Patient with history of thoracic spine surgery. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 27/04/2021 research ethics committee at the faculity of medicine ain shams university
Ethics Committee Address
Street address City Postal code Country
abbasia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cumulative post-operative morphine consumption in the first 48 hr post-operatively. postopertive for 48 hours
Secondary Outcome 1- Post-operative pain severity assessed by VAS (at 0 point (the full recovery state), 1 hr, 2 hr, 4 hr, 6 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr at rest and during cough). 2- Procedure time from scanning to injection of local anesthetic (LA) correctly. 3- The onset of the block. 4- Patient satisfaction during procedure (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)) (17). 5- Patient satisfaction after 1st post-operative day (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)). 6- Incidence of post-operative nausea and vomiting. 7- Incidence of complications (hematoma, procedure induced pneumothorax, LA toxicity, respiratory depression). postoperative for 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculity of medicine ain shams university abbasia cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed anwer sobhy abbasia cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculity of medicine ain shams university abbasia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
farouk kamal eldin abbasia cairo 11591 Egypt
samia ibrahim sharaf abbasia cairo 11591 Egypt
Ayman Mokhtar Kamaly abbasia cairo 11591 Egypt
Amr Mohamed Hilal Abdou abbasia cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed shendy ahmedanwer@med.asu.edu.eg 0201273214325 ain shams
City Postal code Country Position/Affiliation
cairo 11591 Egypt assistent lecturer of Anesthesia Intensive Care and Pain Management
Role Name Email Phone Street address
Scientific Enquiries samia sharaf samia_sharaf@yahoo.com 0201223108085 abbasia
City Postal code Country Position/Affiliation
cairo 11591 Egypt Professor of Anesthesia Intensive Care and Pain Management
Role Name Email Phone Street address
Public Enquiries farouk abd elaziz Dr.faroukkamal@med.asu.edu.eg 0201066241179 abbasia
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer of Anesthesia Intensive Care and Pain Management
Role Name Email Phone Street address
Scientific Enquiries ayman kamaly kamaly333@med.asu.edu.eg 0201001453563 abbasia
City Postal code Country Position/Affiliation
cairo 11591 Egypt Professor of Anesthesia Intensive Care and Pain Management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be avilable Study Protocol not applicable not applicable
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