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.: PACTR201710002718112 Date of Approval: 22/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hyaluronidase Versus Adrenaline as an Adjuvant to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries
Official scientific title Hyaluronidase Versus Adrenaline as an Adjuvant to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries
Brief summary describing the background and objectives of the trial Background Hyaluronidase Versus Adrenaline as an Adjuvant to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries.adjuvants to local anaesthetic drugs can reduce the time to achieve complete sensory block and also reduce time to adequate surgical anaesthesia after supraclavicular brachial plexus block. a suitable adjuvant enhances postoperative analgesia by prolonging the duration of block, decreasing the need for systemic analgesic and, so allowing for earlier hospital discharge. ¿ From our knowledge there is no study done to compare hyaluronidase with adrenaline as an adjuvant to bupivacaine in supraclavicular brachial plexus block. objectives To improve quality of supraclavicular brachial plexus block for upper limb surgeries by adding either adrenaline or hyaluronidase as an adjuvant to bupivacaine.¿ To compare the efficacy of addition hyaluronidase or adrenaline as an adjuvant to bupivacaine in supraclavicular brachial plexus block for upper limb surgeries as regard to the onset of time and duration of the sensory and motor block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Surgery,upper limb surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/09/2017
Actual trial start date 09/09/2017
Anticipated date of last follow up 05/03/2018
Actual Last follow-up date 05/03/2018
Anticipated target sample size (number of participants) 90
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 randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomisation 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 group (1) (C) 40 ml 40 ml of 0.375% bupivacaine are used to block supraclavicular plexus under ultrasound guidance 30 Active-Treatment of Control Group
Experimental Group group (11) (H) ( hyaluronidase group) 40 ml 40 ml of 0.375% bupivacaine plus 3000 IU hyaluronidase are used to do ultrasound guided supraclavicular plexus block 30
Experimental Group group (111) ( A) (Adrenaline group) 40ml 40 ml of bupivacaine 0.375% plus 5ug/ml adrenaline are given to do ultrasound guided brachial plexus block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patient acceptance. ¿ Age 20-60 years old. ¿ ASA I and ASA II. ¿ Accepted mental state of the patient. ¿ Elective Unilateral upper limb surgeries below the level of the shoulder. ¿ Patient refusal. ¿ Pregnancy ¿ ASA Grade 3 and 4 ¿ Neurological deficit involving brachial plexus. ¿ Any bleeding disorder and patient on any anticoagulants. ¿ Local infection at the injection site. ¿ Chronic steroid use. ¿ Severe respiratory disease. ¿ Disturbed conscious level. ¿ History of allergy to local anesthetics or hyaluronidase or adrenaline. ¿ Chronic renal failure 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 05/09/2017 ZU-IRB
Ethics Committee Address
Street address City Postal code Country
Zagazig medical faculty, Zagazig, Assharkia Zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Time to achieve complete sensory block The time to reach loss of sensation in the pinprick test at all four nerves distribution
Secondary Outcome ¿ Needling Time The time interval from skin infiltration to the last local anaesthetic injection
Secondary Outcome motor block assessment The extent of motor block will be tested at 0, 2, 5, 10, 15, 20, 30 min after the block
Secondary Outcome ¿ Surgical anaesthesia When the total sensorimotor score will be ¿ 2 points with a sensory score will be ¿ 1 point
Secondary Outcome ¿ Total performance time The sum of needling time and the time to achieve surgical anaesthesia
Secondary Outcome Duration of analgesia Time from the last local anaesthetic injection to the first report of postoperative pain at the surgical site that is VAS ¿ 4
Secondary Outcome ¿ Duration of motor block Time from the last local anaesthetic injection to complete motor function recovery in the hand and forearm.
Secondary Outcome ¿ Patient satisfaction Patients will be asked to rate their opinions and experience of the anaesthesia by using a 7-point Likert scale question (1= extremely un- satisfied, 4= fair, 7= very satisfied) after the first postoerative 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
zagazig university hospitals zagazig university, zagazig, assharkia zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
zagazig university hospitals zagazig university zagazig 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor zagazig university hospitals anesthesia department, faculty of medicine, zagazig university zagazig 44519 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
osama yehia ahmad khalifa anesthesia department,zagazig medical faculty zagazig 44519 Egypt
fatma mahmoud ahmed anesthesia department, zagazig medical faculty, zagazig 44519 Egypt
shereen elsayed abd ellatif anesthesia department, zagazig medical faculty zagazig 44519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Osama Yehia Ahmad Khalifa yehia2001@hotmail.com 00201007579438 anesthesia department, zagazig medical faculty
City Postal code Country Position/Affiliation
zagazig 44519 Egypt
Role Name Email Phone Street address
Public Enquiries fatma mahmoud ahmed FaTmakasem169@yahoo.com 00201095790313 anesthesia department, zagazig medical faculty, zagazig university
City Postal code Country Position/Affiliation
zagazig 44519 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries osama yehia ahmad khalifa yehia2001@hotmail.com 00201007579438 anesthesia department, zagazig medical faculty, zagazig university
City Postal code Country Position/Affiliation
zagazig 44519 Egypt lecturer
REPORTING
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