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.: PACTR202208582938205 Date of Approval: 03/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between bupivacaine 0.5% only versus mixture of bupivacaine 0.5% with xylocaine 2% or xylocaine 1.5% only in ultrasound guided axillary brachial plexus block for creation of surgical brachio-cephalic fistulae in chronic renal failure patients on hemodialysis.
Official scientific title Comparative study between bupivacaine 0.5% only versus mixture of bupivacaine 0.5% with xylocaine 2% or xylocaine 1.5% only in ultrasound guided axillary brachial plexus block for creation of surgical brachio-cephalic fistulae in chronic renal failure patients on hemodialysis.
Brief summary describing the background and objectives of the trial In our study we are trying to reach to the local anesthetic agent, or agents, its concentration, and its volume to be used during ultrasound guided axillary brachial plexus block that will be probably the most suitable to fit the anesthetic and surgical requirements for the successful creation of brachiocephalic fistula as regarding onset of surgical anesthesia, duration of intra-operative anesthesia, the need for surgical wound infiltration, duration of postoperative analgesia and the failure rate of the fistulae.
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 In our study we are trying to reach to the local anesthetic agent, or agents, its concentration, and its volume to be used during ultrasound guided axillary brachial plexus block that will be probably the most suitable to fit the anesthetic and surgical requirements for the successful creation of brachiocephalic fistula as regarding onset of surgical anesthesia, duration of intra-operative anesthesia, the need for surgical wound infiltration, duration of postoperative analgesia and the failu
Anticipated trial start date 01/06/2021
Actual trial start date 30/06/2020
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 30/01/2022
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
Recruitment status Completed
Publication URL https://www.hindawi.com/?utm_source=google&utm_medium=cpc&utm_campaign=HDW_MRKT_GBL_SUB_ADWO_PAI_KEYW_HIND_X_BRAND_E&gclid=CjwKCAjwur-SBhB6EiwA5sKtjoTYkm1JKfp4UwZTorfIoldeVrk38GVyXE9UUOqATHFPGOUAaSO_nhoCtkAQAvD_BwE
Secondary Ids Issuing authority/Trial register
Secondary ID Issuing Authority
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group B 30 ml volume OF BUPIVACAINE 0.5% injection of local anesthetic results in anesthesia of the brachial plexus which lasts for nearly 10 hours a 50-mm 18-gauge insulated short bevel needle was directed under ultrasound guidance toward each of the three terminal nerves (medial, ulnar, and radial). The needle was moved to several points around each nerve to facilitate circumferential perineural LA spread. A total of 30 mL of LA solution was injected and then observed to make sure each nerve become surrounded. 22
Control Group Group X 30 ml of xylocaine 1.5 % anesthesia time is about 5 hours a 50-mm 18-gauge insulated short bevel needle was directed under ultrasound guidance toward each of the three terminal nerves (medial, ulnar, and radial). The needle was moved to several points around each nerve to facilitate circumferential perineural LA spread. A total of 30 mL of LA solution was injected and then observed to make sure each nerve become surrounded 22 Dose Comparison
Experimental Group group BX 15 ml of xylocaine 2% mixed with 15 ml of bupivacaine 0.5% this produces anesthesia for about 10 hrs a 50-mm 18-gauge insulated short bevel needle was directed under ultrasound guidance toward each of the three terminal nerves (medial, ulnar, and radial). The needle was moved to several points around each nerve to facilitate circumferential perineural LA spread. A total of 30 mL of LA solution was injected and then observed to make sure each nerve become surrounded. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists not more than Grade III, age 25–75 years who were scheduled for brachiocephalic AVF. Patients will be excluded if they have infection at the injection site allergy to local anesthetics, chronic use of opioids, a history of neurological neuromuscular, or severe hepatic or cardiopulmonary disease, a contraindication to regional anesthesia or patient refusal. Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 27 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 02/09/2018 Research Ethics committee Ain Shams university
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt Cairo 3753450 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the outcome is to figure out which drug or drug mixture gives better results and patient satisfaction as regard onset of the block, duration of the block and first time to inquire analgesia.in this trial we compare three patients groups every 10 minutes
Primary Outcome To detect the local anesthetic agent or agents that gives early anesthesia and prolonged post operative analgesia 5 minutes
Secondary Outcome the failure rate of the fistulae. every 12 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams university hospitals. ramsis street abbasia 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim salah mohammed abdelady Ramses St. Abbasia Cairo 3753450 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams University Abbasia Cairo 3753450 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim salah mohammed abdelhady Ramses st Cairo 3753450 Egypt
Karim Ahmed Sedky Abdelrahman El sherok Cairo 3753450 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelhady Ibrahimsalahabdelhady@med.asu.edu.eg 00201117580874 Ain shams
City Postal code Country Position/Affiliation
Cairo 3753450 Egypt Assistant lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries karim sedky kareemahmedsedky@gmail.com 00201223377539 el sherok
City Postal code Country Position/Affiliation
cairo 3753450 Egypt lecturer of anesthesia and ICU Ain shams university.
Role Name Email Phone Street address
Scientific Enquiries amira soliman AMIRAFSOLIMAN@HOTMAIL.COM 002010111349691 sheraton
City Postal code Country Position/Affiliation
cairo 3755220 Egypt prof. of anesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
link to protocol not avialable 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