Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201912552470635 Date of Approval: 05/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Different Volumes of Bupivacaine in Ultrasound Guided Supraclavicular Brachial-Plexus Block for Upper Limb Arterio-venous Hemodialysis Access Procedures
Official scientific title Different Volumes of Bupivacaine in Ultrasound Guided Supraclavicular Brachial-Plexus Block for Upper Limb Arterio-venous Hemodialysis Access Procedures
Brief summary describing the background and objectives of the trial Background: Regional anesthesia is usually preferred in arteriovenous shunt surgery to maintain adequate blood flow post-operatively which can prevent thrombosis and fistula failure. Supraclavicular brachial plexus block (BPB) also enable rapid and efficient block. However, choosing the dose in patients with systemic disease is essential to decrease the possible systemic toxicity. Objectives: Our study aimed to evaluate the outcomes of using two varied volumes of bupivacaine for ultrasound-guided supraclavicular BPB in patients with end-stage renal disease undergoing arteriovenous shunt creation surgery. Methods: This prospective controlled, comparative study was carried on 50 adult CRF patients, with physical status ASA III classification, scheduled for elective arterio-venous shunt creation. The enrolled patients were divided equally into 2 groups, the first group (group I) received 28 ml of plain bupivacaine 0.5% and the second one (group II) received 18 ml of plain bupivacaine 0.5%.
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: Other
Anticipated trial start date 03/12/2019
Actual trial start date 03/12/2019
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date 01/06/2020
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet 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 high volume bupivacaine group throughout the procedure received 28 ml of plain bupivacaine 0.5%. 25 Active-Treatment of Control Group
Experimental Group Low volume bupivacaine group through the procedure received18 ml of plain bupivacaine 0.5%. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with CRF which defined as progressive kidney damage with glomerular filtration rate (GFR) <15 mL/min/1.73 m2 for 3 months or more irrespective of cause which is the point of needing dialysis with physical status ASA III classification were included in the study . Patients with neurological deficit of the upper limb, mental dysfunction and bleeding disorders or with a history of allergy to local anesthetics were excluded from the study. Also, Patients younger than 20 Years old and older than 60 Years old did not included in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 01/04/2018 Aswan university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El seel street Aswan 097348223 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale (VAS) for first24hours. postoperative
Secondary Outcome Onset of sensory block : After injection of the solution (time zero) every patient was checked in the following times: 0, 5, 10, 20, 30 and 60 minutes for onset of sensory blockade using pinprick test using the following scale (three-point scale): • 0 points = pinprick perceived as painful (normal sensation), • 1 point = analgesia to pinprick, • 2 points = anesthesia to pinprick (no perception) Duration of sensory block (hr): It's the time from sensory block onset to time of restoration of sensation at the surgical site. Onset of motor block : After injection of the total dose of LA (time zero) every patient was checked in the following times: 0, 5, 10, 20, 30 and 60 minutes for onset of motor blockade using the following scale: • 0 points = no paresis • 1 point = paresis, • 2 points = complete paralysis Duration of motor block (hr) :It's the time from motor block onset to restoration of global mobility in the elbow, hand and the wrist. Success rate: identified as complete sensory and motor block. Duration of Surgery and Complications: such as chest discomfort, Horner's syndrome, voice changes and pneumothorax. preoperative,intraoperative and postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aswan university El seel street Aswan 097348223 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif kamal Hafez Arafa Egypt- Gharbia- Tanta Gharbia 040331111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sherif kamal arafa Egypt- Tanta Gharbia Tanta 040331111 Egypt Funding Agency
Secondary Sponsor Amir Abouzkry Egypt - Shebeen Shebeen 040323070 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa Egypt- Gharbia- Tanta Gharbia 040331111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifarafa1020@gmail.com 00201005714014 Egypt-Gharbia-Tanta
City Postal code Country Position/Affiliation
Gharbia 040331111 Egypt Lecturer of anesthesia and ICU in Kfer El Shigh university
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 00201005714014 Egypt-Gharbia-Tanta
City Postal code Country Position/Affiliation
Gharbia 040331111 Egypt Lecturer of anesthesia and ICU in Kfer El Shigh university
Role Name Email Phone Street address
Scientific Enquiries Amir Abuzikary aabozikry@yahoo.com 00201016326544 Egypt- Shebeen
City Postal code Country Position/Affiliation
Shebeen 040331111 Egypt Lecturer of anesthesia and ICU in Aswan university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I- Visual analogue scale (VAS) for first24hours. II- Onset of sensory block : After injection of the solution (time zero) every patient was checked in the following times: 0, 5, 10, 20, 30 and 60 minutes for onset of sensory blockade using pinprick test using the following scale (three-point scale): • 0 points = pinprick perceived as painful (normal sensation), • 1 point = analgesia to pinprick, • 2 points = anesthesia to pinprick (no perception) III- Duration of sensory block (hr): It's the time from sensory block onset to time of restoration of sensation at the surgical site. IV- Onset of motor block : After injection of the total dose of LA (time zero) every patient was checked in the following times: 0, 5, 10, 20, 30 and 60 minutes for onset of motor blockade using the following scale: • 0 points = no paresis • 1 point = paresis, • 2 points = complete paralysis V- Duration of motor block (hr) :It's the time from motor block onset to restoration of global mobility in the elbow, hand and the wrist. VI- Success rate: identified as complete sensory and motor block. VII- Duration of Surgery VIII- Complications: such as chest discomfort, Horner's syndrome, voice changes and pneumothorax. Study Protocol 2 years To those who request the data via e - mail of the principal investigator according to the cause of request
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
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