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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202409764079235 Date of Registration: 06/09/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Postoperative Analgesic Effect of Lumbar Erector Spinae Plane Block versus Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
Official scientific title The Postoperative Analgesic Effect of Lumbar Erector Spinae Plane Block versus Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries
Brief summary describing the background and objectives of the trial Orthopedic procedures involving the hip have remained challenging for regional anesthesia due to the complex innervation, painful nature contributing to difficulty positioning, and a desire to maintain mobility to hasten postoperative recovery. Multimodal anesthesia is of great importance to limit the use of opioids and their associated adverse effects such as respiratory depression, nausea, and vomiting. Utilizing regional anesthesia helps to limit the use of opioids, however, which technique is best has yet to be determined. The erector spine plane block (ESPB), a relatively new block, was effective in providing hip analgesia without a motor block for the quadriceps muscles. Two major benefits to this block are its relatively low risk of complications due to its anatomical position and the lack of risk of mechanical nerve damage as there is no direct contact with any nerves. Previous studies have found histologically that the anterior capsule has predominantly nociceptive fibers, while the posterior capsule is largely made up of mechanoreceptors. The pericapsular nerve group (PENG) block targets the block of these articular branches that provide hip innervation. This regional anesthetic technique was described by Giron-Arango et al in 2018 for acute analgesia of hip fractures. The PENG block targets the sensory branches only and doesn't target the posterior mechanoreceptors; it has a motor-sparing effect which is preferable for early ambulation and discharge and better physical therapy. We aimed to compare the analgesic effect of ESPB and PENG block in hip surgery pain control.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) phase 3
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date 01/08/2024
Anticipated target sample size (number of participants) 69
Actual target sample size (number of participants) 69
Recruitment status Completed
Publication URL N/A
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pericapsular nerve group block Before anesthesia With patients in a supine position, group 1patients will receive PENG block under USG guidance using curvilinear low-frequency ultrasound probe (2–5 MHz) initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees to visualize the Iliopubic Eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle. A 22Gauge 80 mm needle will be inserted in-plane and the needle tip will be positioned in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. 30 mL of 0.25% bupivacaine will be injected in increments while observing for an adequate fluid spread in this plane. 23
Experimental Group Erector spinae plane block Before anesthesia Group 2 (ESPB) patients will receive preoperative lumbar ESPB. ESPB will be performed on the ipsilateral surgical side under ultrasound with a curvilinear transducer (5–2 MHz) and a 22-gauge, 3.5-in needle (Chiba). The patient will be placed in the lateral decubitus position with the operative side facing up. The transducer will be placed in a parasagittal plane along the spinous process. After identifying the spinous process of the L4 vertebrae, the probe will be moved laterally to identify the L4 transverse process. If the L4 level was not easily visible, the ultrasound probe will be moved cephalad to identify either the L3 or L2 transverse processes. Using an out-of-plane technique, the needle will be inserted and advanced until making contact with the transverse process, after which it will be withdrawn slightly. Once negative aspiration is confirmed, 30 ml of 0.25% bupivacaine will be administered. A craniocaudal spread of local anesthetic providess confirmation of appropriate needle position. Block success will be assessed by the loss of cold sensation in the posterolateral distribution of the hip 15 minutes after block placement. 23
Control Group Control group Before operation Spinal anesthesia will be chosen as the main anesthetic technique and will be provided with 0.5% bupivacaine at the L3–L4 interspace, and the sensory block will be controlled at T8–T10. No nerve block will be administered 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who will undergo hip surgery. Patients of either sex. Patients above the age of 18. Patients with the American Society of Anesthesiologists (ASA) classes I and II. Patient refusal for regional anesthesia. History of local anesthetic allergy, bleeding disorder or anticoagulant therapy. local-site infection. Clinical significant neurological disease. ASA Clases III and IV. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 01/02/2023 Menoufia University Faculty of Medicine Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Menoufia University 32511 Shebin ElKom Menoufia Egypt. Shebin ElKom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The numerical rating scale NRS at the time before and 30 min after the blockade (by passive internal rotation of the fractured lower limb to neutral position from its typical external rotation deformity), and at 3, 6, 12, 18, 24 and 48 hours postoperative of both resting and dynamic pain. 30 minutes after the blockade and at 3, 6, 12, 18, 24 and 48 hours postoperative
Secondary Outcome The strength of the quadriceps, the total morphine consumption, the first time of postoperative out-of-bed mobilization and any complications will be recorded. At the time before and 30 min after the blockade, and at 3 hours, 6 hours, 12 hours, 18 hours, 24 hours and 48 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospital Menoufia governorate Egypt Faculty of Medicine, Menoufia University, 32511 Shebin El-Kom, Menoufia, Egypt. Shebin ElKom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nonfundable study Faculty of Medicine Menoufia University 32511 Shebin ElKom Menoufia, Egypt. Shebin ElKom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Menoufia University Faculty of Medicine Menoufia University 32511 Shebin El-Kom Menoufia Egypt. Shebin ElKom Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Islam ElDesoky islamdesoky@gmail.com +201092447887 Faculty of Medicine, Menoufia University, 32511 Shebin El-Kom, Menoufia, Egypt
City Postal code Country Position/Affiliation
hebin ElKom Egypt Department of Anesthesiology Intensive Care and Pain Management Faculty of Medicine Menoufia University 32511 Shebin ElKom Menoufia Egypt.
Role Name Email Phone Street address
Public Enquiries Islam ElDesoky islamdesoky@gmail.com +201092447887 Faculty of Medicine, Menoufia University, 32511 Shebin El-Kom, Menoufia, Egypt
City Postal code Country Position/Affiliation
Shebin Elkom Egypt Department of Anesthesiology Intensive Care and Pain Management Faculty of Medicine Menoufia University 32511 Shebin ElKom Menoufia Egypt.
Role Name Email Phone Street address
Scientific Enquiries Islam ElDesoky islamdesoky@gmail.com +201092447887 Faculty of Medicine, Menoufia University, 32511 Shebin El-Kom, Menoufia, Egypt
City Postal code Country Position/Affiliation
Shebin Elkom Egypt Department of Anesthesiology Intensive Care and Pain Management Faculty of Medicine Menoufia University 32511 Shebin ElKom Menoufia Egypt.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with an academic interest in nerve block techniques. Data or samples shared will be coded, with no personal information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Statistical Analysis Plan Data requests can be submitted 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis plan and execution of a Data Sharing Agreement
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