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.: PACTR201910904223565 Date of Approval: 07/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness Of Intravenous Dexamethasone On Fascia Iliaca Compartment Block with Bupivacaine As Part Of Postoperative Multimodal Analgesia For An Open Reduction And Internal Fixation Surgery Of Femoral Fracture In Hawassa University Comprehensive Specialized Hospital, South Ethiopia, 2018.
Official scientific title Effectiveness Of Intravenous Dexamethasone On Fascia Iliaca Compartment Block with Bupivacaine As Part Of Postoperative Multimodal Analgesia For An Open Reduction And Internal Fixation Surgery Of Femoral Fracture In Hawassa University Comprehensive Specialized Hospital, South Ethiopia, 2018.
Brief summary describing the background and objectives of the trial Background: Fascia iliaca compartment nerve block is used for open reduction and internal fixation surgery of femoral fracture. Though dexamethasone is added to peripheral nerve block to increase analgesia efficacy but its effect on fascia iliaca is not known. Objective: To assess the effectiveness of intravenous dexamethasone on fascia iliaca compartment block with bupivacaine as a part of postoperative multimodal analgesia for open reduction and internal fixation of femoral bone fracture in Hawassa University Comprehensive Specialized Hospital from October 01, 2018 to January 30, 2019.
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 Postoperative pain
Anticipated trial start date 01/10/2018
Actual trial start date 01/10/2018
Anticipated date of last follow up 30/01/2019
Actual Last follow-up date 30/01/2019
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
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 by using procedures such as coin-tossing or dice-rolling 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
Control Group saline 2 ml normal saline intravenously 24 hours Normal saline is the common crystalloid fluid used in clinical setup 30 Placebo
Experimental Group Dexamethasone 8 mg intravenously 24 hours Chemical properties of dexamethasone Dexamethasone is a synthetic corticosteroid and derivative of cortisol (hydrocortisone) and is also known as an anti-inflammatory 9-fluoro-glucocorticoid. Dexamethasone is a glucocorticoid drug which is used in clinical set up for somatic pain, neuropathic pain, and visceral pain; this is due to its less fluid retention (mineralocorticoid effect), longer duration of action and greater potency than other glucocorticoid drugs like prednisone or prednisolone. It is pain reducing mechanism is controversial. The proposed mechanisms are supposed to be firstly by inhibiting prostaglandin synthesis, which has great role pain transduction ant transmission process, secondly dexamethasone decrease inflammatory process, inflammation and reducing vascular permeability that results in tissue edema and pain transduction. Pharmaco vigilance of dexamethasone The complication related to drug injection is rising blood glucose level and risk of infection which may or may not occur but still to ensure safety we will use lower therapeutic dose which devoid of side effects, even higher dose for prophylaxis and management PONV will not cause such side effects in single dose. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 18 to 65 years, ASA grade 1 and 2 Allergy to local anaesthetic and steroids, peripheral neuropathy, additive to spinal anaesthesia, bleeding diathesis, previous femoral bypass surgery, inguinal hernia, inflammation or infection over injection site, diabetics, patients on previous opioid therapy, psychiatric disorders and Polytrauma. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 04/09/2018 Dilla University College of medical and health sciences institutional review board
Ethics Committee Address
Street address City Postal code Country
Dilla university Dilla 1000419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to first analgesia request between groups a time in hours it takes from loss of sensation to needle pinprick to patient request for analgesia or first analgesia is given.
Secondary Outcome 1. pain severity (in NRS) between groups 2. total 24 hour postoperative analgesics consumption between groups at 0, 3, 6, 12, 18 and 24 hours post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hawassa university comprehensive specialized hospital Anesthesia departement Hawassa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla, Ethiopia Dilla 1000419 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla, Ethiopia Dilla 1000419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Semagn Mekonnen Dilla University Dilla 1000419 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Diriba Teshome diribat2@gmail.com +251912765735 Debre Tabor University
City Postal code Country Position/Affiliation
Debre Tabor 1000272 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Semagn Mekonnen semek17@gmail.com +251913864605 Dilla University
City Postal code Country Position/Affiliation
Dilla 1000419 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ephrem Fenta ephfen2007@gmail.com +251966261787 Debre Tabor University
City Postal code Country Position/Affiliation
Debre Tabor 1000272 Ethiopia lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes collected data Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not set Yes There were statistically significant differences between the groups in time to first analgesia request p-value of =0.003, tramadol, diclofenac and morphine consumption with p-value of, 0.017, 0.036 and 0.046 respectively. Regarding pain severity score a statistical significant differences were found at 6 and 12 hours with p-values of 0.039 and 0.024 respectively while there was no statically significant difference in incidence of postoperative nausea vomiting (p =0.448). 06/09/2019 06/09/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks not set
Changes to trial information