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.: PACTR202006669166858 Date of Approval: 19/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Intravenous Fentanyl, Femoral Nerve Block and Fascia Iliaca Block on Reducing Pain During Positioning for Spinal Anesthesia in Elective Adult Patients undergoing Surgery for Femoral Fracture
Official scientific title Effectiveness of Intravenous Fentanyl, Femoral Nerve Block and Fascia Iliaca Block on Reducing Pain During Positioning for Spinal Anesthesia in Elective Adult Patients undergoing Surgery for Femoral Fracture at Hawassa University Comprehensive Specialized Hospital, SNNPR, Ethiopia 2019.
Brief summary describing the background and objectives of the trial Femoral fracture is the most painful bone injury and performing spinal anesthesia is extremely challenging due to very poor positioning unless we have a very good mode of analgesia. Intravenous strong opioids are commonly used but to date nerve blocks are also utilized. Reliability and effectiveness of the aforementioned methods are not conclusive to practice worldwide. The objective of the study is to compare effectiveness of intravenous fentanyl, femoral nerve block and fascia iliaca compartment block in reducing pain during positioning for spinal anesthesia in adult patients with femoral fracture who undergo orthopedic surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 07/06/2020
Actual trial start date
Anticipated date of last follow up 30/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group IVF group Fentanyl 1μg/kg IV Five minutes before positioning single injection Fentanyl 1μg/kg IV Five minutes before positioning for spinal anesthesia 24 Active-Treatment of Control Group
Experimental Group Femoral Nerve Block group Femoral nerve block with 30 ml of 1% plain lidocaine 15 minute before positioning single injection Femoral nerve block ( FNB) will be performed with the patient positioned supine; the femoral artery pulse is palpated at the level of the inguinal ligament. After cleaning the area with alcohol and iodine a short (5-cm) insulated needle is inserted at a45° angle to the skin in a cephalad direction until a distinct quadriceps twitch (patella dancing) is elicited with a current between 0.5mA and 0.2mA then careful aspiration will be performed and 30mL of 1% plain lidocaine will be injected. 24
Experimental Group Facia Illiaca Compartment Block group 30 ml of 1% plain lidocaine single injection Facia illiaca compartment block will be performed once the inguinal ligament and femoral artery pulse are identified; the length of the inguinal ligament is divided into thirds. Two centimeters distal to the junction of the middle and outer thirds, a short, blunt-tipped needle will be inserted in a slightly cephalad direction after cleaning with alcohol and iodine. As the needle passes through the two layers of fascia in this region (fascia lata and fascia iliaca), two “pops” will be felt. Oncethe needle has passed through the fascia iliaca, careful aspiration will be performed and 30mL of 1% plain lidocaine will be injected. 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elective surgery ASA class I, II Age 18 – 65 Known allergy to lidocaine or fentanyl Contraindication to spinal anesthesia (patient refusal, bleeding problem) Patients with additional fracture other than femur Bilateral femoral fracture History of chronic pain History of opioid with in 12hrs preoperatively Morbid obesity (body mass index (BMI) > 35 kg/m2) Impaired cognition or dementia , Infection on cite of block Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 19/12/2019 Dilla university collage of medical health science institutional review board
Ethics Committee Address
Street address City Postal code Country
2912 Dilla 2912 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Numeric rating score (NRS) before, during and after intervention
Secondary Outcome time taken to perform spinal anesthesia after completion of spinal anesthesia
Secondary Outcome quality of patient positioning during positioning
Secondary Outcome patient satisfaction after spinal anesthesia and 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
HAWASSA UNIVERSITY COMPREHENSIVE SPECIALIZED HOSPITAL 2421 Hawassa 4100 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla university Dilla university Dilla 2912 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla university 2912 Dilla 2912 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MELAKU BANTIE bmelaku088@gmail.com +251929183264 2923
City Postal code Country Position/Affiliation
Dilla 2923 Ethiopia lecturer
Role Name Email Phone Street address
Scientific Enquiries SIMENEH MOLA ksimenehmola@yahoo.com +251901091414 2914
City Postal code Country Position/Affiliation
Dilla 2914 Ethiopia lecturer
Role Name Email Phone Street address
Public Enquiries TIMSEL GIRMA timsikebron15@gmail.com +251944060952 2924
City Postal code Country Position/Affiliation
Dilla 2924 Ethiopia lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share all necessary data upon request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years open
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