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.: PACTR202111575647784 Date of Approval: 16/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title General Anesthesia and Femoral Nerve Block versus Spinal Anesthesia for Cemented Hip Arthroplasty in elderly patients: A randomized controlled trial
Official scientific title General Anesthesia and Femoral Nerve Block versus Spinal Anesthesia for Cemented Hip Arthroplasty in elderly patients: A randomized controlled trial
Brief summary describing the background and objectives of the trial Fracture femur is a common orthopedic problem following trauma or falling in elderly patients. Cemented hip arthroplasty may be performed under general or spinal anesthesia. The optimal anesthetic technique remains debated in patients undergoing cemented hip arthroplasty . General anesthesia can be combined with Femoral nerve block to control intra and post operative pain. The aim of this work is to compare general anesthesia combined with femoral nerve block versus spinal anesthesia for performing cemented hip arthroplasty surgeries as regards intraoperative hemodynamics , cardiovascular and respiratory complications, post operative cognitive dysfunction, acute kidney injury, and in hospital mortality.
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 Diagnosis / Prognosis
Anticipated trial start date 01/08/2021
Actual trial start date 15/08/2021
Anticipated date of last follow up 30/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
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 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
Control Group Spinal intrathecal Anesthesia 2.5 ml (12.5 mg) of 0.5% heavy bupivacaine intrathecal intra-operative and postoperative for 48 hours Spinal anesthesia is done while the patient is in the sitting position and under complete aseptic technique using a 25-gauge Quincke needle , a midline intrathecal injection of total volume 2.5 ml (12.5 mg) of 0.5% heavy bupivacaine at L 3/4 L4/5 as appropriate. After successful intrathecal injection, the patient is monitored continuously for block progression and complications. 30 Active-Treatment of Control Group
Experimental Group General Anesthesia and Femoral Nerve Block General anesthesia induction will be performed using intravenous Fentanyl 2 µg/ kg, Propofol 1-2 mg/kg titration ( slow injection till the patient can't reply and stop to use the lowest dose for anesthesia ), and Atracurim 0.5 mg / kg, combined with perineural Femoral nerve block will be performed using a volume of 15-20 mL of 0.5% bupivacaine. intra-operative and postoperative for 48 hours General anesthesia induction will be performed using intravenous Fentanyl 2 µg/ kg, Propofol 1-2 mg/kg titration ( slow injection till the patient can't reply and stop to use the lowest dose for anesthesia ), and Atracurim 0.5 mg / kg as an intubating dose after preoxygenation by 100% O2 for 3 minutes, followed by endotracheal intubation. Femoral nerve block will be performed under complete aseptic precautions, using ultrasound with a linear transducer placed on the femoral crease to obtain the images of the femoral nerve and artery. The needle used for the block will be an echogenic needle of 22 Gauge and 10cm in length. Once the femoral nerve is visualized, the needle will be inserted in-plane in a lateral to medial orientation and advanced towards the nerve. A volume of 15-20 mL of 0.5% bupivacaine (taking into consideration not to exceed the toxic dose for every patient which is 3mg/kg) will be administered around the femoral nerve after negative aspiration to avoid accidental intravascular injection, and spreading of the drug solution will be observed around the femoral nerve under ultrasound imaging. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a- Patients with American Society of Anesthesiologists physical status (ASA) I, ΙΙ, and IIΙ. b- Both genders. c- Aged ≥60 years old. d- Patients scheduled for cemented hip arthroplasty for fracture femur. a) Patients with major spine deformities. b) Patients with bleeding disorders and coagulopathy or using anticoagulants till the time of operation. c) Infection at the injection site. d) Allergy to local anesthetics. e) Patients having multiple fractures. f) Patients with pre-existing myopathy or neuropathy. g) Patients with significant cognitive dysfunction. h) Patient refusal. I) Patient with increased serum creatinine than 2 mg/ dl or urine output less than 0.5 ml/kg/ hour for 12 hours j) Sever COPD ( chronic obstructive pulmonary disease). K)Patients with history of congestive heart failure ( CHF ), EF < 40%, pulmonary hypertension with estimated RVSP > 45, and sever wall motion abnormalities in multiple walls. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 90 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 23/05/2021 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
38 Abbasia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Intraoperative hemoynamic measurments. every 15 minutes intra-operatively
Secondary Outcome intra-operative respiratory and cardiac complications after cement installment
Secondary Outcome postoperative cognitive dysfunction immediately postoperative and every 12 hours for 48 hours duration
Secondary Outcome acute kidney injury 48 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals 38 Abbasia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principle investigator 1, Abdrlwahab youssef, Gesr elsuze Cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nahla Omar Gesr Elsuze Cairo 11311 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nahla omar dr.nahlaomar@gmail.com +201018895145 1 Abd elwahab youssef st, Gesr El-suze
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Assistant lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Osama Mansour viced.research@med.asu.edu.eg 20226857539 38 Ramsis st, Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Vice dean for graduate studies and research
Role Name Email Phone Street address
Scientific Enquiries Gamal Saleh gamalfouad@gmail.com 01222401438 30 Elhegaz st
City Postal code Country Position/Affiliation
Ciro 11511 Egypt Professor of Anesthesia
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
not available 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