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.: PACTR201912917762180 Date of Registration: 23/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ESPB for hip surgery
Official scientific title Continuous erector spinae plane block for analgesia after hip surgery.
Brief summary describing the background and objectives of the trial Postoperative pain control after orthopedic hip surgery has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction. Moreover; optimal pain management can reduce the duration of hospitalization and the risk of adverse events, such as deep vein thrombus(Bugada et al., 2018; Tulgar, Selvi, et al., 2018). The Erector Spinae Plane (ESP) block was first reported to treat chronic thoracic pain in 2016. Since then, this block has been utilized not only for chronic pain, but also acute postoperative pain for thoracic and abdominal surgeries. Recently, there have been a few case reports describing an ESP Block for hip surgeries. Lumbar ESPB can be used successfully for postoperative analgesia in hip surgery, with similar results when compared to other regional anesthesia techniques such as psoas compartment block and quadratus lumborum block(Forero et al., 2016; El-Boghdadly and Pawa, 2017). ESP block advantages include its simplicity, easy identifiable US landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Regarding the block safety, there have been no specific reported complications of ESPB as there is no direct contact with any nerves in lumbar ESPB(Tulgar, Selvi, et al., 2018; Kinjo and Schultz, 2019; Singh, Ranjan and Lalin, 2019). In this study, continuous ESPB will be assessed as a multimodal analgesia for patients undergoing hip orthopedic surgery. The primary objective will be the Total morphine consumption in the first [postoperative day. Secondary variables include visual analogue scale, analgesia duration, and the incidence of complications. 
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESPB
Disease(s) or condition(s) being studied Anaesthesia,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/12/2019
Actual trial start date 15/12/2019
Anticipated date of last follow up 15/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
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 Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Erector spinae plane block 20 ml of 0.5% bupivecaine 24 hours The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 18-G Tuohy needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction to contact o L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side. Afterwards the catheter will be threaded about 3 cm beyond the needle tip 20
Control Group No intervention control group control group 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients scheduled for hip and proximal femur surgery, age from 21 to 65, with ASA status (I-III). Patient refusal, infection at site of injection, spine deformities, and neurological diseases affecting patient expression of pain will be excluded from the study, contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. ), BMI > 35, known allergy to local anesthetics, ASA IV, and patients with difficulty in evaluating their level of pain Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 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 14/12/2019 institutional research board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 22555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total morphine consumption in the first postoperative day in milligrams 24 hours
Secondary Outcome visual analogue scale 2 hours post admission, at 6 hours and 12 hours post-procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Elgomhoreya Mansoura 22555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrefaey Alrefaey Mansoura university Faculty of Medecine Elgomhoreya Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alreafey Alreafey Elgomhoreya Mansoura Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Heba Abizeid Elgomhoreya Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alreafey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Public Enquiries Alreafey 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 alrefaey refa3ey2@yahoo.com 00201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Manoyra Egypt Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Tables of the results will be available within 12 months of the study start date Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months. controlled. Data can be requested through email of the principal investigator after being approved by an independent review committee.
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