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.: PACTR201512001376158 Date of Approval: 03/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fascia iliaca compartment block
Official scientific title Patient controlled ultrasound guided fascia iliaca compartment block (FICB) with Levobupivacaine versus fentanyl patient controlled intravenous analgesia in patients undergoing femur fracture surgery.
Brief summary describing the background and objectives of the trial Postoperative pain may be undertreated in elderly and the use of opioid analgesics is limited because of fear of adverse events .Effective pain relief is essential for early mobility and discharge from hospital. Patient-controlled analgesia (PCA) enables patients to self titrate bolus doses of analgesics to their desired level of pain relief by using a programmable infusion pump. This individualizes the dose required to maintain adequate analgesia according to the patient¿s needs. Fascia iliaca compartment block is an anterior thigh regional block of lumbar plexus, if local anesthetics injected posterior to the fascia iliaca, it diffuse in to its internal layers then to the femoral, lateral femoral cutaneous, genitofemoral, and obturator nerves which was later confirmed by radiography. It is an alternatives to central neural blockade and provides unilateral analgesia with less side-effects than epidural analgesia. The aim of the current study is to compare the effects of patient controlled ultrasound guided fascia iliaca compartment block (FICB) with Levobupivacaine versus patient controlled intravenous fentanyl for postoperative analgesia in patients undergoing fixation of femur fractures under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,postoperative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2015
Actual trial start date 15/12/2015
Anticipated date of last follow up 01/06/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
30594/11/15 Research ethics committee, Faculty of Medicine, Tanta University
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PCA IV fentanyl group : (F) fentanyl 20 ug/ml solutions through PCA pump. PCA device will be programmed to give a bolus dose 2 ml/dose with a minimal lockout interval of 10 min with no background infusion. 24 h IV patient controlled analgesia 30
Experimental Group PCA guided FICB group PCA adjusted to deliver continous basal infusion of levobupivacaine0.125 percent 4ml per h; demand bolus increments 2ml with lockout inteval 15 min 24 hours Patient controlle FICB 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II patients aged 50-70 years either gender elective fixation of fracture femur any other fractures neurological disease (Alzheimer, dementia) any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality, or patient refusal) known allergy to the study drug. 50 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 15/11/2015 Research Ethics Committee, Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
Tanta Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue pain scale (VAS) immediate 3 h 6 h 12 h 24 h postoperative
Secondary Outcome ¿ Total consumption of rescue analgesia immediate 3 h 6 h 12 h 24 h postoperative
Secondary Outcome ¿ Sedation immediate 3 h 6 h 12 h 24 h postoperative
Secondary Outcome ¿ Postoperative mean arterial blood pressure, heart rate immediate 3 h 6 h 12 h 24 h postoperative
Secondary Outcome ¿ Any concomitant events like nausea; vomiting, shivering, pruritus or respiratory complications any time if occured
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine, Tanta University Tanta Geish Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine. Tanta University Tanta Geish Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of Anesthesia and Surgical ICU, Tanta University Tanta Geish Street Tanta Egypt Hospital
Primary Sponsor Tanta University Tanta Geish Street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk Abdelkader Mostafa 1 Moheb Street Almahalla Alkobra Egypt
Rehab Saeed Alkalla 21 Stad street Tanta Egypt
Gehan Morsy Eid 7 Tharwat Street, Hassan Radwan Tanta Egypt
Mohamed Shebl Abdelghany 9 Abdelgleel Altawab Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk ShaimaaFarouk7777@yahoo.com 01270440771 1 Moheb Street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Gehan Morsy Gehan2552011@gmail.com 01287466651 7 Tharwat Street, Hassan Radwan
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohammed Shebl moh7000@yahoo.com 01063345623 9 Abdelgleel Altawab
City Postal code Country Position/Affiliation
Tanta Egypt Assistant lecturer of anesthesia and ICU, Faculty of medicine, Tanta University
REPORTING
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