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.: PACTR202302491451057 Date of Approval: 08/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between Ultrasound guided External Oblique Intercostal Plane Block and Thoracic Erector Spinae block for Post Thoracotomy Pain
Official scientific title Comparison between Ultrasound guided External Oblique Intercostal Plane Block and Thoracic Erector Spinae block for Post Thoracotomy Pain: A Randomized Prospective Study
Brief summary describing the background and objectives of the trial This prospective double-blinded randomized study will be conducted to evaluate the analgesic efficacy of Ultrasound-guided External Oblique Intercostal Plane Block (EOIB) versus The analgesia provided by erector spinal block after Thoracotomy incision and possible complications in both groups. This prospective double-blinded randomized study will be carried out in Tanta University Hospitals in the Cardiothoracic Surgery Department for 6 months from November 2022 to April 2023 on 60 patients of both genders scheduled for thoracic surgery operated through open thoracotomy incision. Study duration: 6 months from November 2022 to April 2023 Inclusion criteria: Patients scheduled for Thoracic surgery aged between 21- 65 years of both genders, and have ASA I and II. Exclusion criteria: Patient refusal, presence of Infection at the injection site and patients with a history of allergy to local anaesthetics. 60 patients will be equally divided to two equal groups (30 patients for each group) Group 1: Ultrasound-guided External Oblique Intercostal Plane Block Group 2: Ultrasound-guided Erector Spinae Block (ESB) Block will be performed after General anaesthesia induction using the same anaesthetic mixture (30 ml plain bupivacaine 0.25%) injected at the level of the 5th rib in the post-axillary line. - the following will be measured:- 1- Demographic data as (age, sex, Weight, BMI, indication and duration of surgery). 2- Hemodynamic Parameters: mean arterial blood pressure, and heart rate (MAP & HR) will be recorded before block performance at T0 after surgery at T (0, 6, 12, 18, 24 hours) where T0 = before discharge from PACU. 3- Total opioid consumption (morphine) at the first 24 h after surgery. 4- Numeric Rating scale (NRS): NRS will be assessed after surgery over 24 hours during rest and with cough 5- Time to first rescue analgesic requirement after surgery 6- Adverse events as Pneumothorax, and local Anaesthetic systemic toxicity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 15/02/2023
Actual trial start date 15/02/2023
Anticipated date of last follow up 21/10/2023
Actual Last follow-up date 21/10/2023
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Erector Spinae Block 30 ml plain bupivacaine 0.25% single injection Block will be performed after General anesthesia induction using the same anesthetic mixture (30 ml plain bupivacaine 0.25%) injected at T5 level. 30 Active-Treatment of Control Group
Experimental Group External Oblique Intercostal Plane Block 30 ml plain bupivacaine 0.25% single injection after GA induction before skin incision External Oblique Intercostal Plane Block: Block will be performed after General anesthesia induction, using the same anesthetic mixture (30 ml plain bupivacaine 0.25%) injected at T5 level under Ultrasound guidence. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients scheduled for Thoracic surgery aged between 21- 65 years of both genders - ASA physical status I and II. Patient refusal presence of Infection at the injection site patients with a history of allergy to local anesthetics coagulopathy 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 10/11/2022 Faculty of medicine Tanta university research ethics committee
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total opioid consumption in the first 24 hours after surgery. 24 hours after surgery
Secondary Outcome • Time to first rescue analgesic demand after surgery. hourly after end of surgery
Secondary Outcome • Numeric Rating Score (NRS) during rest and with coughing T1 at PACU,T 2 2 Hour after discharge from PACU, T3 at 4h, T4 at 6h,T5 at 12 h, T6 at 18 h,T7 at 24 h
Secondary Outcome • Complications occur as (hypotension, pneumothorax, Local Anaesthetic Systemic Toxicity (LAST)). any incidence during performing the block or after that
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El-Gharbia Govenorate,Tanta . El-Gash st. Medical Campus The Faculty of Medicine Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal investigator 5th,Medhat mahmoud st, Tanta 31111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Saad moharam 5th medhat mahmoud, elestad, tanta Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. amgad shaban elsheikh elgeish st, tanta tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saad Moharam saad2hmed@gmail.com +201090663262 5th medhat mahmoud, tanta, elgharpeya
City Postal code Country Position/Affiliation
tanta 31527 Egypt Lecturer of anesthesia and surgical icu at faculty of medicine Tanta university hospital
Role Name Email Phone Street address
Public Enquiries amgad elsheikh amgad.elsheikh@gmail.com +201099204343 elestad
City Postal code Country Position/Affiliation
tanta Egypt lecturer of anesthesia and surgical icu
Role Name Email Phone Street address
Scientific Enquiries saad moharam saad2hmed@gmail.com 201090663262 5th medhat mahmoud, tanta
City Postal code Country Position/Affiliation
tanta Egypt lecturer of anesthesia and surgical icu
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data will be shared after the complete recruitment of the patients in our study and a summary of the results will be available and shared as well. I will also publish these analyzed data within 12 months after ending the study. Informed Consent Form,Statistical Analysis Plan 1 year controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
saad2hmed@gmail,com 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