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.: PACTR202003487312437 Date of Approval: 17/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title dexamethasone dose as an adjuvant in supra clavicular block
Official scientific title Lower effective dose of dexamethasone as an adjuvant to bupivacaine in supra-clavicular block: comparetive study.
Brief summary describing the background and objectives of the trial The supraclavicular block is a regional anesthetic technique used as an alternative or adjuvant to general anesthesia or used for postoperative analgesia for upper limbs surgeries. dexamethasone is a one of most common additive drugs to local anaesthesia. ceiling dose of dexamethasone is questionable,In this clinical trial , we will study the ceiling dose of dexamethasone according to recent puplished meta –analysis 4 mg with sub ceiling dose 3mg as an adjuvant to bupivacaine in supra clavicular block, comparing their analgesic efficacy and possible side effects and complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) dexamethasone
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/03/2020
Actual trial start date
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacine only 25 ml isobaric bupivacaine 0.5%. single dose injection the anaesthesiologist catching sterile high-frequency (10–13 MHz) linear probe of toshiba-xario ultrasound machine is used to scan the neck transversely between the level of cricoid cartilage and supraclavicular fossa until an optimal view of the hypoechoic round images of C5 and 6 nerve roots or upper trunk is obtained , A 22-gauge 50-mm block needle is then carefully inserted parallel (in-plane from lateral to medial) for single-shot nerve blocks, 25 ml isobaric bupivacaine 0.5%. preparation will be injected and will be demonstrated by good spread relative to the plexus 20 Dose Comparison
Experimental Group bupivacine and 3 mg dexamethasone 25 ml isobaric bupivacaine 0.5%+ 3mg dexamethasone. single dose injection the anaesthesiologist catching sterile high-frequency (10–13 MHz) linear probe of toshiba-xario ultrasound machine is used to scan the neck transversely between the level of cricoid cartilage and supraclavicular fossa until an optimal view of the hypoechoic round images of C5 and 6 nerve roots or upper trunk is obtained , A 22-gauge 50-mm block needle is then carefully inserted parallel (in-plane from lateral to medial) for single-shot nerve blocks, 25 ml isobaric bupivacaine 0.5%+ 3mg dexamethasone. of study drugs preparation will be injected and will be demonstrated by good spread relative to the plexus 20
Experimental Group bupivacine and 4 mg dexamethasone 25 ml isobaric bupivacaine 0.5%+4 mg dexamethasone. single dose injection the anaesthesiologist catching sterile high-frequency (10–13 MHz) linear probe of toshiba-xario ultrasound machine is used to scan the neck transversely between the level of cricoid cartilage and supraclavicular fossa until an optimal view of the hypoechoic round images of C5 and 6 nerve roots or upper trunk is obtained , A 22-gauge 50-mm block needle is then carefully inserted parallel (in-plane from lateral to medial) for single-shot nerve blocks, 25 ml isobaric bupivacaine 0.5%+4 mg dexamethasone of study drugs preparation will be injected and will be demonstrated by good spread relative to the plexus 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults of both sex ASA I or II aging 18-65 years undergoing upper limb orthopedic surgery in mansoura university hospitals. • patient refusal • allergy to local anesthetics • infection at injection site • malignancy at the needle entry site • coagulopathy • patients maintained on anticoagulation therapy • severe pulmonary disease • preexisting neural deficits exist in the distribution of the block. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 08/03/2020 IRB mansoura university
Ethics Committee Address
Street address City Postal code Country
elghomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome analgesia duration 0,1,2,3,4,5,6 h. post operative
Secondary Outcome VAS 0,1,2,3,4,5,6 H post operative
Secondary Outcome total dose pethidine consumption 24 h, post operative 24 h. post operative
Secondary Outcome heart rate, MABP, respiratory rate, Spo2, RBS 0,1,2,4,8,12,24h. postoperative
Secondary Outcome complication like infection , delayed wound healing 7 day post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elghomhoria street elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mmohamed abouelela khatab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university elghomhoria street el mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elghomhoria elmansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university
Role Name Email Phone Street address
Public Enquiries samah elkenany sk_20022000@yahoo.com 00201002262557 elgamah street
City Postal code Country Position/Affiliation
elmansoura Egypt assistant proffesor of anaesthesia mansoua university
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study desigm, methods, results Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 month after completion of study through IRB mansoura university
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