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.: PACTR202402718826002 Date of Approval: 20/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in iliopsoas plane block for hip surgeries
Official scientific title Dexamethasone versus dexmedetomidine as a local anesthetic adjuvant to bupivacaine in ultrasound guided iliopsoas plane block for hip surgeries
Brief summary describing the background and objectives of the trial hip fracture surgeries are associated with moderate to severe pain, which hampers early mobilization, extends the hospital stay and worsens postoperative function.hip fracture surgeries are associated with moderate to severe pain, which hampers early mobilization, extends the hospital stay and worsens postoperative function.this trial will be conducted to compare dexamethasone against dexmedetomidine as adjuvant to IP .With the primary objective will be the analgesic duration for postoperative pain relief after hip surgeries . The strength of quadriceps muscle, postoperative pain scores, the hemodynamic parameters and any side effects will be considered as secondary objectives
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 Treatment: Drugs
Anticipated trial start date 20/02/2024
Actual trial start date 20/02/2024
Anticipated date of last follow up 01/05/2024
Actual Last follow-up date 01/08/2024
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 78
Recruitment status 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group Group C patients will received Ultrasound guided illiopsas plane block with the mixture containing 10 ml of 0.25%bupivacaine with 2 ml of 0.9%normal saline .The total volume 12 ml one shot intraoperative after induction of general anesthesia and before surgical incision patients will received Ultrasound guided illiopsas plane block with the mixture 12 ml volume 26 Placebo
Experimental Group Dexamethasone group Group DS the injected volume containing10 ml of 0.25%bupivacaine with 8mg dexamethasone equal 2ml.The total volume 12 ml one shot intraoperative before surgical incision patients will received Ultrasound guided illiopsas plane block with the mixture containing10 ml of 0.25%bupivacaine with 8mg dexamethasone equal 2ml.The total volume 12 ml 26
Experimental Group Dexmedetomidine group Group DM the injected volume containing 10 ml of 0.25% bupivacaine with 100 ug dexmedetomidine and 1ml of 0.9%normal saline .The total volume equal12 ml one shot intraoperative before surgical incision patients will received Ultrasound guided illiopsoas plane block with the mixture containing 10 ml of 0.25% bupivacaine with 100 ug dexmedetomidine and 1ml of 0.9%normal saline .The total volume=12 ml 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients of either sex patients aged between 21 and 80 ASA grade I, II , III scheduled for unilateral elective hip surgery repair. • Patient refusal. • Hematological diseases, bleeding or coagulation abnormality. • Sepsis and local skin infection at site of the block. • Known hypersensitivity to the study drugs. • Associated sever uncompensated diseases (cardiac, respiratory, hepatic or renal disease. • Neuromuscular diseases (as myopathies, myasthenia gravies…) • Body mass index (BMI) more than 35 kg/m2. • Psychiatric diseases. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 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 18/12/2023 institutional review board Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgomhouria street mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of analgesia calculated from the completion of injection of local anesthetic till the first demand of the rescue analgesia.
Secondary Outcome quadriceps strength and VAS pain scores 2, 4, 6, 24, 48 h postoperative
Secondary Outcome total opioids consumption, first time out of bed, patient satisfaction, and complications 48 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura Emergency Hospital Jihan street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine mansoura university Elgomhouria street mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university faculty of medicine Elgomhouria street mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reem Abdelraouf Elsharkawy reemraouf64@gmail.com 00201006151100 Elgomhouria street
City Postal code Country Position/Affiliation
Mansoura Egypt Reem AE Sharkawy
Role Name Email Phone Street address
Public Enquiries Rania Elmohamady Elbadrawy raniaelmohamady@gmail.com 00201003689480 Elgomhouria street
City Postal code Country Position/Affiliation
Mansoura Egypt Rania E Elbadrawy
Role Name Email Phone Street address
Scientific Enquiries Sherine Ali Elsayed Bakrey sherinbakrey@mans.edu.eg 00201208703575 Elgomhouria street
City Postal code Country Position/Affiliation
Mansoura Egypt Sherine A Bakry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intended sharing of individual trial participant data within 12 months completion date with a researcher covered with institutional review board Statistical Analysis Plan,Study Protocol within 12 months of the study completion date controlled with any researcher or organization covered by ethical committee
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