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.: PACTR202301914053306 Date of Approval: 26/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lumbar erector spinae plane block versus iliopsoas plane block for hip arthroplasty analgesia
Official scientific title Efficacy of the Lumbar erector spinae plane block on the quality of analgesia after hip arthroplasty; a prospective randomized comparative study with iliopsoas plane block
Brief summary describing the background and objectives of the trial Hip surgeries are associated with moderate to severe pain, which hinders early mobilization and extends the hospital stay. (1) Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation, and respiratory depression. (2) There are many options for post hip arthroplasty analgesia Including: spinal morphine; femoral, obturator and lateral femoral cutaneous nerve block; lumbar plexus block; continuous epidural block; and fascia iliaca block. Intrathecal morphine has some adverse effects: pruritus, urinary retention, nausea and vomiting. The fascia iliaca block may be accompanied by partial failure. Blockade of femoral, obturator, and lateral femoral cutaneous nerves requires 3 injections and a larger volume of local anesthetic. The epidural technique may lead to hypotension and motor weekness. Lumbar plexus block is a deep block, with greater risk of complications such as retroperitoneal hematoma, deep bleeding, of greater technical difficulty, and erratic local anesthetic spread. (3,4-7). All these blocks could weaken the strength of the quadriceps muscle and increase the risk of fall. Recent motor sparing regional anesthetic blocks have been proved effective in providing postoperative analgesia in hip surgeries including; lumber erector spinae (LESP) block (8-10) and iliopsoas plane block (IPB). (11) To our best knowledge, there is the first study to compare the efficacy of LESP block and IPB for postoperative hip arthroplasty analgesia. The aim of this study is to compare the analgesic effect of LESP block and IPB in patients subjected to hip arthroplasty.
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 Prevention
Anticipated trial start date 07/01/2023
Actual trial start date 07/01/2023
Anticipated date of last follow up 06/04/2023
Actual Last follow-up date 06/04/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL unavailable
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lumbar erector spinae plane block 30 ml bupivacaine 0.25%) before spinal anesthesia At the level of the 4th lumbar vertebra. A convex ultrasound transducer will be placed at the mid-vertebral line in the sagittal plane. The transducer will be moved laterally from the midline, 3.5–4 cm on the same side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-plane technique a 22G spinal needle will be advanced until reaching the transverse process, then 0.5–1 ml of the prepared local (LA) solution (30 ml bupivacaine 0.25%) will be administered to make hydro dissection to confirm correct position. All LA was administered to this location between the transverse process and the erector spinae muscle 30 Active-Treatment of Control Group
Experimental Group Iliopsoas plane block 10 ml of 0.25% bupivacaine before spinal anesthesia With the patient is in the supine position, the ultrasound probe will be placed in the horizontal plane distal to the anterior superior iliac spine. Then, the probe will be rotated approximately 30° anticlockwise and slid along the inguinal ligament until visualizing the enterance of the femoral head into the edge of the acetabulum. The needle will be passed through the sartorius and iliopsoas muscles until reaching the iliopsoas plane between the iliopsoas muscle and the iliofemoral ligament, then 10 ml of 0.25% bupivacaine will be injected after confirming the correct needle place. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
either sex, aging > 18 , ASA I–III undergoing hip arthroplasty under spinal anesthesia * Patients who refuse to participate, * Have a history of bleeding disorder, *Receiving anticoagulant medications, * Polytrauma patients * Patients who had chronic pain or had received opioid analgesic in the preceeding two weeks, * Patients with an infection at the sites of injections, and * Patients who are unable to communicate. 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 29/10/2022 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
ElGomhoria street Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The cumulative PCA morphine consumption after surgery 24 - h after surgery
Secondary Outcome 1. Pain scores at rest and on movement evaluated by VAS score at PACU,1, 2, 4, 6, 12 and 24h after surgery. 2. Time to first rescue analgesia (the duration of postoperative analgesia). 3. Quadriceps strength will be assessed using manual muscle testing grades (MMT grades) (0–5; 0: no muscle contraction, 5: can bear full resistance). 4. Adverse effects; sedation, nausea, vomiting, pruritus and needle trauma. 24h after surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals ElGomhoria street Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self ElGomhoria street Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura faculty of Medicine ElGomhoria Mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samah Elkenany sk_20022000@yahoo.com 002010022624557 Mecca street Hay El Gamaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mohamed Eslam El shehawia melshehawi@gmail.com 00201000035990 ElGomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Sherin Bakrey Rosh_2000@yahoo.com 00201022544897 Abd elsalam Areef
City Postal code Country Position/Affiliation
Mansoura 35514 Egypt Lecturer
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, after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol immediately following publication, No end date . open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable 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