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.: PACTR202211633784671 Date of Approval: 24/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title analgesia for hip surgery
Official scientific title Pericapsular Nerve Group Block VS Femoral Nerve Block in Hip Surgery: Comparative Study, Double Blind Clinical Trial
Brief summary describing the background and objectives of the trial Femoral nerve block has been considered the block of choice for patients with hip surgery. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia. objectives: 1) Assessment the efficacy of PENG and femoral nerve block as analgesic and preserving motor functioning in hip surgery. 2) Assessment the safety of PENG and femoral nerve block in as analgesic and preserving motor functioning in hip 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 newly introduced block for post hip surgery analgesia
Anticipated trial start date 01/12/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 74
Actual target sample size (number of participants) 74
Recruitment status Not yet 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group femoral nerve block it is a peripheral nerve block that will be adminstered preoperatively 20 ml of local anesthetic (LA) solution (bupivacaine 0.25%) expected block duration about 24 hrs The femoral artery and vein are medial to the femoral nerve at the level of the inguinal ligament. When using ultrasound, the transducer is placed transversely at the inguinal crease, and the femoral vessels are located. If multiple arteries are present (i.e., superficial and deep femoral arteries), then slide the probe proximally until only the common femoral artery is visualized along with its associated femoral vein. Immediately lateral to the femoral vessels, the femoral nerve classically appears as a hyperechoic wedge or ovoid structure. The femoral nerve is superficial to the iliopsoas muscle group; and it is deep to the fascia lata and fascia iliaca, respectively. Once the femoral nerve and relevant neighboring structures have been identified, a lidocaine wheal is administered before the block needle insertion into the tissue, and the needle tip is advanced below the fascia iliaca towards the femoral nerve. Either an in-plane or out-of-plane approach may be used, depending on the proceduralist’s preference. Confirming negative aspiration for heme is recommended before injection to avoid intravascular injection. The ultrasound monitor will show the spreading of local injection around the nerve. Caution is necessary with unusually high injection pressure or nerve expansion with injection, which may indicate intraneural injection 37 Active-Treatment of Control Group
Experimental Group Pericapsular Nerve Group Block 20 ml 0f 0.25% bupivacine 24 hours post technique the block as described by Girón-Arango et al. (Girón-Arango et al. 2018) will be performed with the patient in the supine position using ultrasound guidance (high-frequency probe, L7M-A probe7.5 MHz, CHISON, Jiangsu, China). The probe will be initially placed in a transverse plane over the anterior inferior iliac spine (AIIS), and then rotated 45 degrees anticlockwise to be roughly aligned with the pubic ramus. After keeping the iliopectineal imminence| (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be maintained in the view, a 22-gauge, 80-mm needle will be introduced from lateral to medial in an in-plane approach. When the tipoff the needle is visualized in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly, 20 ml of local anesthetic (LA) solution (bupivacaine 0.25%) will be injected in 5-mL increments while observing for adequate fluid spread 37
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a hip fracture presenting for surgery, aged 45 years and older, without contraindications for regional anesthesia. 1. Patients with uncontrolled hypertension, hyperthyroidism or severe dementia 2. allergy to ropivacaine 3. Regional anatomical abnormalities or infections at the site of block. 4. Bleeding disorders e.g., thrombocytopenia, high INR, high PT in patients known to have chronic liver disease or impaired kidney. 5. Patients on chronic pain medications or regularly receiving analgesics. 6. Patients with high kidney functions e.g., high serum creatinine level. Middle Aged: 45 Year(s)-64 Year(s) 45 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 14/11/2022 Research ethic committe faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road ismailia ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The postoperative NRS pain score will be followed up for 34 hours postoperatively. 1, 4, 8,12, 16, 24
Secondary Outcome • NRS pain scores on day 1 postoperatively. • Postoperative quadriceps strength. o Quadriceps strength will be assessed using the knee extension test11 and Oxford muscle strength grading12 with grouped scores of intact (5/5), reduced (1-4/5) and absent (0/5). • Perioperative opiate use. o Opiate use will be reported as use intraoperatively, on day 0, first request of analgesia postoperatively, and total use of analgesia for 6 hours postoperatively will be reported. o PCA would be used for patient when needed with bolus dose of 50 mcg and infusion rate of ≤ 10mcg/h of fentanyl, total dose of fentanyl administered to the patient over 6 hours postoperatively and its onset of action will be reported. • Postoperative complications. • Time of first request of analgesia and dosage. • Length of hospital stay. • patient satisfaction and patient-reported outcomes measures (PROMs). o On day 1, parameters of patient satisfaction, pain experienced, and quality of recovery will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks for evaluation of depression and pain interference, Brief Pain Inventory (BPI) and the Quality of Recovery (QoR-15) questionnaires (Appendix 1). o The APS assessed patient satisfaction and pain management on day 1. o Patients will be asked to recall the time the block wore off, defined as return of motor (if initially impaired) and/or sensory recovery. for 24 hrs postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road kilo 4 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the main investigator dr mina makram ring road kilo 4 ismailia 14522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mina makram ring road ismailia fuclty of medicinde ismailia 14522 Egypt Individual
Secondary Sponsor hossam atef ismailia 14522 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mina makram minamakram123456@gmail.com 0200193256308 ring road kilo 4
City Postal code Country Position/Affiliation
ismailia 14522 Egypt resident
Role Name Email Phone Street address
Public Enquiries hossam atef hossamatef@med.suez.edu.eg 02001064663086 ring road
City Postal code Country Position/Affiliation
ismailia 14522 Egypt associate prof
Role Name Email Phone Street address
Scientific Enquiries galal habib gelge@yahoo.com 02001159752897 ring road kilo 4
City Postal code Country Position/Affiliation
ismailia 14522 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes excel sheet containning patient data witout revieling identity and results Clinical Study Report by may 2023 shared pdf
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