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.: PACTR202307810865219 Date of Approval: 19/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study Between The impact of Ultrasound Guided Pericapsular Nerve Group Block (PENG) Versus Fascia Iliaca Compartment Block (FICB) On The quality of Postoperative Analgesia and Ambulation in Hip Arthroplasty
Official scientific title A Comparative Study Between The impact of Ultrasound Guided Pericapsular Nerve Group Block (PENG) Versus Fascia Iliaca Compartment Block (FICB) On The quality of Postoperative Analgesia and Ambulation in Hip Arthroplasty
Brief summary describing the background and objectives of the trial Hip surgeries are one of the common orthopedic surgeries, especially in the geriatric population following trauma and central neuraxial block such as spinal anesthesia is the preferred technique for providing anesthesia. Correct positioning during central neuraxial block is an important prerequisite for a successful procedure. However, limb immobility and extreme pain are the deterrents for an ideal positioning for this procedure. Postoperative pain is a nightmare so adequate analgesia by variable regional nerve blocks with local anesthetic have been advocated to reduce the pain. In this study, Pericapsular Nerve Group block will be compared to Fascia Iliaca Compartment block, both will be done Ultrasound guided using bupivacaine (0.25%).
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: Other
Anticipated trial start date 01/10/2022
Actual trial start date
Anticipated date of last follow up 01/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound Guided Pericapsular Nerve Group Block volume of 20 mL of (0.25% bupivacaine) taking into consideration not to exceed the toxic dose for every patient (2.5mg/kg) after spinal anesthesia and before surgical intervention it will be performed under complete aseptic precautions, using an ultrasound device with a linear transducer positioned on the thigh over a line just beneath the inguinal ligament and parallel to it. It will be subsequently rotated 45° to identify anterior inferior iliac spine, the ilio pubic eminence and the psoas tendon. 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. It will be introduced in plane to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. volume of 20 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. 15
Control Group Fascia Iliaca Compartment Block volume of 20 mL of (0.25% bupivacaine) taking into consideration not to exceed the toxic dose for every patient (2.5mg/kg) after spinal anaesthesia and before surgical intervention the fascia iliaca compartment block will be performed under complete aseptic precautions, using an ultrasound device with a linear transducer positioned on the thigh below the inguinal ligament in a transverse orientation one third of the distance between anterior superior iliac spine and pubic tubercle. 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. It will be introduced in plane. The needle tip will be visualized penetrating firstly fascia lata then fascia iliaca with the feeling of two pops respectively. , volume of 20 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. 15 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) I to II. b- Both sexes. c- Age group: 21 to 70 years old. d- Scheduled for unilateral hip arthroplasty under spinal anesthesia. a) Patients with major spine deformities. b) Patients with bleeding disorders and coagulopathy. c) Infection at the injection site. d) known allergy to local anesthetics. e) Patients having multiple fractures. f) Patients with pre-existing myopathy or neuropathy. g) Patients with significant cognitive dysfunction. h) Body Mass Index (BMI) ≥40 or ≤ 18 Kg/m². i) patient refusal , Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 24/09/2022 Research Ethics Commitee at the faculty of medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia square, Next to Alnour Mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome early postoperative ambulation and the postoperative pain free interval (till the 1st dose of rescue analgesia required in both groups) 12hr, 24hr, 48hr
Secondary Outcome total dose of rescue analgesia consumption VAS in 1/2hr, 2hr, 4hr, 8hr, 12hr, 24hr, 48hr postoperatively
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 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle inverstigator 374 gardenia city compound cairo 1181 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 Al Nour Mosque cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Abdelmoneim Fouly 5th settlement cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mostafa Abdelsattar moustafamahmoud@med.asu.edu.eg +201142626177 374 Gardenia city compound
City Postal code Country Position/Affiliation
cairo Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohsen Basiouny mohsenbassiony@hotmail.com +201223188512 5th settlement
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Principal Investigator Tamer Nabil tamernabil610@gmail.com +201018303438 october city
City Postal code Country Position/Affiliation
Giza Egypt assistant professor
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 Immediately following publication No end data An one who wishes to access the data For 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