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.: PACTR202008752287119 Date of Approval: 11/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector spinae plane block for upper limb surgery
Official scientific title Erector spinae plane block for upper limb surgery
Brief summary describing the background and objectives of the trial Different regional anesthetic technique has been used for pain control after upper limb surgeries, aiming to reduce opioid requirements and allow earlier start of physiotherapy. The most commonly used approach is brachial plexus block (ISB), since it provides effective postoperative analgesia upto 12 hours. Erector spinae plane block (ESPB) has been reported for a variety of indications such as thoracic and abdominal surgery, and recently, was used as an alternative to a BP block for an upper extremity surgical procedure. The study investigates efficacy of cervical ESP block for perioperative analgesia in upper limb suregries
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESPB for UL suregry
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/07/2020
Actual trial start date 20/08/2020
Anticipated date of last follow up 10/09/2020
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group General anesthesia 24 hours after surgery patient will undergo his surgery under general anesthesia 25 Active-Treatment of Control Group
Experimental Group ESPB group ESPB will be performed under ultrasound guidance before the induction of anesthesia thirty min prior to the induction of general anesthesia, using an in-plane approach at the T5 transverse process, and after saline hydrodissection of the fascial plane deep to the erector spinae muscle, a10-15 mL 0.250% bupivacaine will be injected followed by the catheter was threaded 10 cm past the cephalad-oriented needle tip into the space 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients scheduled for upper limb orthopedic surgery Kyphoscoliosis Uncooperative patient infection at site of injection drug addiction Adolescent: 13 Year-18 Year,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 21/07/2020 Institutional research board Mansoura University
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative morphine consumption in milligrams first postoperative day
Secondary Outcome postoperative pain scores at 2,4,8,12, 24 hours after surgery first postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospitals Elgomhoreya street Egypt Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrefaey Alreafey Geihan street Mansoura 55333 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alreafey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Public Enquiries Alrefaey Alreafey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Alreafey Alreafey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Masnoura Egypt Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Sharing the study protocol,clinical data, results tables when requested by researchers or institutions covered by an ethical committee or review board Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 month after completion of the study searchers or institutions covered by an ethical committee or review board
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