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.: PACTR202305920421968 Date of Approval: 10/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Suprainguinal Fascia Iliaca Block (SIFB) Vs Multimodal analgesia for pain control following hip hemiarthroplasty
Official scientific title Suprainguinal Fascia Iliaca Block (SIFB) Vs Multimodal analgesia for pain control following hip hemiarthroplasty
Brief summary describing the background and objectives of the trial Optimal perioperative pain management of hip surgery improves the long-term quality of life (Young et al.,2014). Nerve blocks are expected to be more effective for peri-operative pain management than other analgesic techniques (Guay et al.,2017). Although epidural anesthesia and lumbar plexus nerve block for hip surgery were effective analgesics in the perioperative period, performing these nerve blocks was associated with hypotension. Femoral neve block and local infiltration analgesia are not ideal because they don’t cover the full extent of analgesia required for hip surgery (Johnson et al.,2017) (Kuchálik et al.,2017). The fascia iliaca compartment block (FICB) was initially described by (Dalens et al.,1989) on children using a landmark technique. It is an easy to perform and a low-cost procedure which provides efficient perioperative analgesia for patients who suffer from hip or femur fractures. Increased success rates are due to the facilitation of the block via ultrasound which is easily accessible in many operation theaters (Onur et al., 2019). The ultrasound-guided suprainguinal fascia iliaca block, described by Hebbard in 2011, further built on earlier anatomic discoveries to more reliably anesthetize the 3 nerves originally targeted by Winnie: femoral, lateral femoral cutaneous, and obturator. (Hebbard et al., 2011) (Winnie et al., 1973) This relatively simple block has most notably been shown to provide opioid- sparing analgesia in the setting of hip surgery. (Desmet et al., 2017) Aim of this study is to analyze the effectiveness of ultrasound-guided supra inguinal fascia iliaca compartment block (SIFI) versus multimodal analgesia for postoperative pain relief in hip hemiarthroplaty. Main variables will be the total amount of opioid consumption by the patient, analgesic requirements and ambulation.
Type of trial CCT
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 01/12/2022
Actual trial start date 02/06/2023
Anticipated date of last follow up 15/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FWA 000017585
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
Experimental Group Supra Inguinal Fascia Iliaca block 40 ml bupivicaine not exceeding the toxic dose Just one dose at the end of surgery Patients will receive ultrasound guided suprainguinal fascia iliaca block with 0.25% bupivacaine 40 ml (not exceeding toxic dose of bupivacaine 2.5mg/kg) at the end of surgery. 30
Control Group Multimodal analgesia For two days post operative Patients will receive 1-hour pre-operatively oral pregabalin 75 mg, oral celecoxib 200mg and at the end of surgery IV 1gm paracetamol and repeated every 6hours in the first 24 hours after surgery, 30 mg ketorolac IV and repeated every 6 hours not exceeding 120 mg/day in the first 24 hours after surgery, 3mg Morphine IV once. On day 2 patient will receive oral paracetamol 500mg every 6 hours. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a- Patients American Society of Anesthesiologists physical status (ASA 1,2,3) b- Both sexes. c- Aged ≥ 40 to ≤ 70. d- Scheduled for hip hemiarthroplasty under spinal anesthesia. a) Patients with major spine deformities. b) Patient 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. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 08/01/2023 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study is to compare total opioid consumption between the two groups. 24 hours post-operative
Secondary Outcome The secondary outcome will be the time of the fist request for receiving opioid, VAS score, onset of ambulation and complication of nerve block for the first 24 hrs postoperative of the study for both groups. 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 Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principle investigator 114 saqr qorish , sheraton Cairo 11799 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sarah Hamdy 36 hussein ibn ali hegaz street Cairo 11843 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Prof dr Gamal Fouad gamalzaki@gmail.com +201222401438 114 sakr qorish, sheraton
City Postal code Country Position/Affiliation
Cairo 11799 Egypt Professor of anesthesia intensive care and pain management faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Waleed Al Taher Waleedaltaher@hotmail.com +201094785713 32 Mostafa elnahas Elhay eltamen, nasr city
City Postal code Country Position/Affiliation
Cairo 11762 Egypt Professor of anesthesia intensive care and pain management faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Sarah Hamdy Hamdysarah.84@Gmail.com +201002895835 36 hussein ibn ali hegaz street
City Postal code Country Position/Affiliation
Cairo 11482 Egypt Lecturer of anesthesia intensive care and pain management faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification 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