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.: PACTR202211734022792 Date of Registration: 28/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF ERECTOR SPINAE PLANE BLOCK ON POSTOPERATIVE PAIN MANAGEMENT AFTER OPEN CHOLECYSTECTOMY A RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFECTS OF ERECTOR SPINAE PLANE BLOCK ON POSTOPERATIVE PAIN MANAGEMENT AFTER OPEN CHOLECYSTECTOMY A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Background: Postoperative pain after open cholecystectomy is associated with severe pain. Ineffective post cholecystectomy pain management is associated with delayed recovery and complications associated with respiratory system. This increases the incidence of morbidity and hospital stay. Erector spinae plane block is an effective technique for postoperative pain management. The erector spinae block is expected to provide perioperative analgesia, decreased 24 hours opioid consumption and decreased intraoperative opioid consumption for cholecystectomy surgeries. Objectives: The aim of this study is to evaluate the effect of erector spinae plane block on management of post cholecystectomy pain as part of postoperative pain management in Dessie referral hospital. Evaluation of the effects of ESPB on postoperative pain, opioid consumption, and nausea and vomiting was the secondary objective.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESPB
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 20/12/2022
Actual trial start date 02/01/2023
Anticipated date of last follow up 15/06/2023
Actual Last follow-up date 30/06/2023
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ERECTOR SPINAE PLANE BLOCK 30-40 ml, one time 5 minutes The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally 36
Control Group opioid analgesia one time 5 minutes Intravenous (IV) opioids are commonly used to provide analgesia and supplement sedation during general anesthesia or monitored anesthesia care (MAC) and are the most widely used agents for treatment of acute pain in the immediate postoperative period. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• ASA physical status I and II . • Age between 18-45 years • Patients with hypersensitivity to drugs to be used in the study • Patients with a Coagulation disorder • History of using analgesics within 24 hours before surgery • Alcohol and substance abuse • Morbid obesity (BMI>40) Adult: 19 Year-44 Year 18 Year(s) 45 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
No 02/12/2022 Wollo University and Dessie referral hospital ethical committee
Ethics Committee Address
Street address City Postal code Country
Melaku Dessie 1145 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post-operative pain in Numerical Rating Scale 5 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours
Secondary Outcome post operative 24 opioid consumption 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dessie referral hospital Melaku Dessie 1111 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wollo University Menafesha Dessie 1145 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wollo University Melaku Dessie 1145 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sara Timerga sara03tn@gmail.com +251925044807 Menafesha
City Postal code Country Position/Affiliation
Dessie 1145 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Aynalem Befikadu aynalembefkadu31@mail.com +251916583316 Menafesha
City Postal code Country Position/Affiliation
Dessie 1145 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Fasil Mihretu fasilmihretu@gmail.com +251923743831 Menafesha
City Postal code Country Position/Affiliation
Dessie 1145 Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes All of the individual participant data collected during the trial, after deidentification will be available. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal
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