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.: PACTR202112605652525 Date of Approval: 14/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Study between Femoral Nerve Block and Intravenous Ketamine in Pain Management for Elderly Patients with Femur Fracture during Positioning before Spinal Anesthesia
Official scientific title A Comparative Study between Femoral Nerve Block and Intravenous Ketamine in Pain Management for Elderly Patients with Femur Fracture during Positioning before Spinal Anesthesia
Brief summary describing the background and objectives of the trial Aim of this study was to investigate the effect of Ultrasound guided femoral nerve block using 0.25% bupivacaine versus intravenous analgesic ketamine dose (0.25 mg/kg) in pain control for positioning before spinal anesthesia in patients undergoing surgery for fracture femur.
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 pain management
Anticipated trial start date 22/01/2020
Actual trial start date 30/01/2020
Anticipated date of last follow up 10/10/2021
Actual Last follow-up date 30/10/2021
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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
Experimental Group femoral nerve block 20 mL of 0.25% bupivacaine 10 minutes it was performed under complete aseptic precautions, using a transportable Fugi M-Turbo ultrasound system with linear transducer placed on the femoral crease to obtain the images of the femoral nerve & artery. Before proceeding with the nerve block, skin infiltration with LA (1 ml of 2% lidocaine) was done. The needle used for the block was an echogenic needle of 22 Gauge and 4 inches. Once the femoral nerve was visualized, the needle was inserted in-plane in a lateral to medial orientation and advanced towards the nerve. A volume of 15-20 mL of 0.25% bupivacaine (taking into consideration not to exceed the toxic dose for every patient which is 3mg/kg) was administered around the femoral nerve after negative aspiration to avoid accidental intravascular injection, and spread of drug solution was observed in tissue planes under ultrasound imaging. 33
Control Group intravenous ketamine 0.25mg/kg 1 minute intravenous 0.25 mg/kg of ketamine was given 1 minute before positioning for spinal anesthesia 33 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 genders. c- Aged ≥60 years old. d- Scheduled for femur fracture surgeries under spinal anesthesia. Patients with major spine deformities and severe truncal obesity. b) Patients with bleeding disorders and coagulopathy. c) Infection at the injection site. d) History of 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) Patients who received long acting opioids preoperatively. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 80 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 22/01/2020 Research Ethics Committee at Faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbasseya, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score less than 4 before positioning for spinal anesthesia during positioning for spinal anesthesia
Secondary Outcome postoperative analgesic effect measured postoperatively for 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine at Ain Shams University Ramsis street, Abbassia square cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mai essam mohamed 50 nakhla el motiee street, triumph square , el nozha cairo 00202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine at Ain Shams university Ramsis, Abbassia square cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mai essam mohamed maiessam@med.asu.edu.eg 01066825513 50 Nakhla el motiee street, triumph square
City Postal code Country Position/Affiliation
cairo Egypt Assistant lecturer of Anesthesiology at faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Ossama Mansour viced.research@med.asu.edu.eg +20224346344 Ramsis street
City Postal code Country Position/Affiliation
cairo 11591 Egypt Vice Dean of research committee at faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries amr gaber dramrgaber7@gmail.com 01005013194 ramsis street
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of anesthesiology at faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/12/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/12/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information