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.: PACTR202203540692904 Date of Approval: 30/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF ULTRASOUND-GUIDED BILATERAL ERECTOR SPINE PLANE BLOCK VERSUS RECTUS SHEATH BLOCK ON POSTOPERATIVE ANALGESIA FOR MIDLINE ABDOMINAL SURGERY: A RANDOMISED CONTROLLED TRIAL STUDY
Official scientific title EFFECTIVENESS OF ULTRASOUND-GUIDED BILATERAL ERECTOR SPINE PLANE BLOCK VERSUS RECTUS SHEATH BLOCK ON POSTOPERATIVE ANALGESIA FOR MIDLINE ABDOMINAL SURGERY AT WOLAITA SODO UNIVERSITY COMPREHENSIVE SPECIALIZED HOSPITAL, SOUTHERN ETHIOPIA: A RANDOMISED CONTROLLED TRIAL STUDY
Brief summary describing the background and objectives of the trial In surgeries involving the midline abdominal incision, the use of erector spine plane block and rectus sheath block for postoperative pain management is becoming increasingly popular. However, the most effective, safe, and suitable type of this regional analgesic approach remains unanswered. The main aim of this study is to compare the effects of ultrasound-guided bilateral Erector spinae plane block versus rectus sheath block on postoperative analgesia for a midline abdominal surgery from February to June 2022 at wolaita sodo university comprehensive specialized hospital, Southern Ethiopia
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: Other
Anticipated trial start date 04/04/2022
Actual trial start date
Anticipated date of last follow up 07/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL http://doi.org/10.1111/anae.16421
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound guided Erector spine plane block A total of 20mL of 0.25% bupivacaine will be injected on one side. The same procedure will be performed on the opposite side with 20mL of 0.25% bupivacaine. single injection The patient will be positioned in either a sitting or lateral decubitus position. After that, the skin will be prepared and the linear ultrasound transducer will be placed in a longitudinal orientation three cm lateral to the T9 spinous process. Then, the fascia of the erector spinae muscle will be recognized as superficial to the top of the transverse process. Under aseptic situations, a 22-gauge needle will be inserted in a caudal-to-cephalad course by using an in-plane approach and advanced until the needle tip touches the top of the transverse process of T9 vertebrae. The needle tip position will be confirmed via a visualized linear distribution of fluid lifting the erector spinae muscle from the transverse process on ultrasonography imaging. Then A total of 20mL of 0.25% bupivacaine will be injected on one side. The same procedure will be performed on the opposite side with 20mL of 0.25% bupivacaine. Negative aspiration will be confirmed for every 5 mL injection. 36
Control Group Ultrasound guided bilateral rectus sheath block Then, 20mL of 0.25% bupivacaine will be administered under the aseptic technique. The same procedure will be repeated on the opposite side. single injection Rectus sheath block will be performed in a supine position. After preparing the skin, the rectus abdominis muscle will be identified by placing the linear ultrasound probe in a longitudinal orientation next to the incision site above the level of the umbilicus, and a 22-gauge needle will be inserted in an in-plane approach, medial-to-lateral direction, to place the needle tip in the plane between the lateral side of the rectus abdominis muscle and the posterior rectus sheath. After that, the position of the needle tip will be confirmed via a visualizing linear distribution of fluid lifting the rectus abdominis muscle from the posterior rectus sheath on ultrasonography imaging. Then, 20mL of 0.25% bupivacaine will be administered under the aseptic technique. The same procedure will be repeated on the opposite side. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Voluntary patients aged from 18 to 65 years undergoing midline abdominal incisions patient refusal Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR> 1.5) History of allergic reactions to lidocaine or/and bupivacaine Signs of infection at the injection site Emergency surgery History of chronic pain Surgery under spinal anesthesia Adolescent: 13 Year-18 Year,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 28/03/2022 Wolaita Sodo University college of health science Ethical Review Committe
Ethics Committee Address
Street address City Postal code Country
wolaita sodo, Ethiopia wolaita sodo 400 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome .Severity of postoperative pain 24 hours after an ultrasound-guided bilateral erector spine plane or rectus sheath block.
Primary Outcome Time to first rescue analgesic administration 24 hours after an ultrasound-guided bilateral erector spine plane or rectus sheath block.
Primary Outcome Total postoperative analgesia consumption during the first 24 hours following the ESPB or RSB performance
Secondary Outcome Postoperative complications 24 hours after an ultrasound-guided bilateral erector spine plane or rectus sheath block.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wolaita Sodo University Comprehensive Specialized Hospital SNNP sodo town 4620 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Alemu Urmale wolaita, sodo sodo Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wolaita Sodo University SNNP, Ethiopia sodo 134 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alemu Urmale alemuurmale45@gmail.com +251945832063 wolaita sodo, SNNP, Ethiopia
City Postal code Country Position/Affiliation
sodo Ethiopia lecturer in advanced clinical anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohammed Sulaiman msuleiman43@gmail.com +251911379793 Wolaita Soddo, Ethiopia
City Postal code Country Position/Affiliation
sodo Ethiopia He is a senior research consultant at the Federal Ministry of Health
Role Name Email Phone Street address
Public Enquiries Mebratu Legesse mebleg@gmail.com +251926105896 Wolaita Sodo, Ethiopia
City Postal code Country Position/Affiliation
sodo Ethiopia Associate Professor of Clinical Pharmacy and Continuous Professional Development Director at WSU College of Health Sciences and Medicine
Role Name Email Phone Street address
Public Enquiries Andualem Assefa andualem2011@gmail.com +251911815212 wolaita sodo, Ethiopia
City Postal code Country Position/Affiliation
sodo Ethiopia lecturer in advanced clinical anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article will be available to researchers whose proposed use of the data has been approved by an independent review committee, after de-identification. Data requestors should direct the proposal to alemuurmale45@gmail.com and will need to sign a data access agreement to gain access. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication open access
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