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.: PACTR202209850411320 Date of Approval: 16/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study between postoperative analgesia of suprainguinal fascia iliaca compartment block (SIFI) and lumbar Erector spinae plane block (ESPB) in hip arthroplasty
Official scientific title A comparative study between postoperative analgesia of suprainguinal fascia iliaca compartment block (SIFI) and lumbar Erector spinae plane block (ESPB) in hip arthroplasty
Brief summary describing the background and objectives of the trial Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Adequate analgesia with minimal side-effects allows for early postoperative mobility, optimal functional recovery and decreased postoperative morbidity Peripheral nerve blocks are effective adjuvant options for pain management for hip arthroplasty. The use of nerve blocks has been proven to be very effective at controlling pain and minimizing narcotic requirements after hip arthroplasty. In this study, suprainguinal fascia iliaca compartment block will be compared to erector spinae plane block, both will be done Ultrasound guided using bupivacaine (0.25%) for postoperative analgesia at the end of surgery
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 Treatment: Drugs
Anticipated trial start date 15/09/2022
Actual trial start date
Anticipated date of last follow up 15/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants)
Recruitment status Completed
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group suprainguinal fascia iliaca plane block 40 ml bupivacaine 0.25 in each site of injection single injection for 10 - 15 mins at end of surgery After surgery regarding suprainguinal fascia iliaca block: The approach to the suprainguinal fascia iliaca block will be very similar to that described by Hebbard in 2011. The patient is positioned supine with extended hip, The anterior superior iliac spine (ASIS) is palpated, the ultrasound probe is placed slightly inferior and medial to it. typical probe positioning over the inguinal ligament with an angle more perpendicular to the inguinal ligament is often preferable. A high-frequency linear ultrasound probe is typically sufficient, although a lower frequency curved probe may be desirable for obese patients. (Hebbard et al., 2011) Using Desmet technique an echogenic B-bevel needle is inserted with an in-plane technique from the inferior aspect of the probe just superior to the ligament with a significantly steeper angle, which enhances the tactile loss of resistance that is typically felt upon traversing the fascia iliaca and entering the iliacus muscle below (Desmet et al., 2017). After the “pop” through fascia iliaca, the needle may need to be withdrawn slightly to rest at the superficial border of the iliacus. Then, 1-2 ml of saline or local anesthetic is injected to confirm spread between the hyperechoic fascia iliaca and the more heterogeneous iliacus muscle beneath it. With appropriate spread, the needle is further advanced into the pocket of local anesthetic, moving in the cephalad direction as the iliacus muscle is hydro dissected away from the overlying fascia iliaca. 28 Active-Treatment of Control Group
Experimental Group Erector spinae plane block 40 ml of bupivacaine 0.25 at each site of injection single shot for 10-15 mins at end of surgery Regarding the Erector spinae plane block: The approach will be very similar to that described by Tulgar S, Senturk O 2017. the patient will be placed in the lateral position. A high-frequency linear probe or a curved probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2–3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of L4, the erector spinae muscle, and the psoas muscle will be identified. An echogenic B-bevel needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, local anesthetic will be injected behind the erector spinae muscle. (Tulgar and Senturk.2017) Before proceeding with the nerve block, and after sterilization, skin infiltration with local anesthetic (1 ml of 2% lidocaine) will be done. The needle used for the block will be an echogenic needle of 22 Gauge and 4 inches. In both groups, A volume of 40 mL of (0.25% bupivacaine) taking into consideration not to exceed the toxic dose for every patient (2.5mg/kg) will be administered after negative aspiration to avoid accidental intravascular injection, and spread of drug solution will be observed in tissue planes under ultrasound imaging 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a- Patients American Society of Anesthesiologists physical status (ASA) Ⅰ to Ⅲ b- Both sexes. c- Aged ≥ 20 to ≤ 70. d- Scheduled for hip arthroplasty under spinal anesthesia. a) Patients with major spine deformities. b) Patient`s refusal c) Patients with bleeding disorders and coagulopathy. d) Infection at the injection site. e) known allergy to local anesthetics. f) Patients having multiple fractures. g) Patients with pre-existing myopathy or neuropathy. h) Patients with significant cognitive dysfunction. i) Patients who received long-acting opioids preoperatively. j) Failed spinal anesthesia. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 02/07/2022 research ethics committee faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38, abbassia square next to masjed Alnour Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare total opioid consumption between the two groups. from the end of surgery till 24 hours post operative
Secondary Outcome will be time of the 1st request dose of opioid, VAS score , onset of ambulation and complication of nerve block for the first 24 hrs postoperative of the study. from the end of surgery till 24 hours post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38, abbassia square, next to masjed Alnour cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle investigator district 8, Obour City ,Qaluopia Government obour 11828 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of Medicine Ain Shams University 38, abbassia square next to masjed Alnour cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdelaziz Abdelaziz Mansour block 17023 ,District 8 , Obour City , Qaluopia Government obour 11828 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mai Mohsen maimohsen79@yahoo.com +201006219121 abbas alaqad st, Naser city
City Postal code Country Position/Affiliation
CAiro 02 Egypt assistant professor of Anesthesia and intensive care at faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ahmed Abdelaziz ahmed.a.mansour@med.asu.edu.eg +201069589852 district 8 , Obour city
City Postal code Country Position/Affiliation
Obour City 11828 Egypt assistant lecturer of Anesthesia and intensive care at faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Principal Investigator Tamer Samir drtasamir@hotmail.com +201154601505 Naser cty
City Postal code Country Position/Affiliation
Cairo 1181 Egypt lecturer of Anesthesia and intensive care at faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual data collected during the trial , after de-identification Study Protocol following publication any purpose
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