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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001433312 Date of Registration: 20/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Different Volumes of Local Anesthetics in Ultrasound-Guided Combined Interscalene-Supraclavicular Block for Traumatic Humeral Fracture
Official scientific title Different Volumes of Local Anesthetics in Ultrasound-Guided Combined Interscalene-Supraclavicular Block for Traumatic Humeral Fracture
Brief summary describing the background and objectives of the trial Background: Procedures that require anesthesia of entire length of the arm should have combined ISB and SCB to ensure high success rate. But dual block requires high dose of local anesthetic. Ultrasound-guided nerve block help in decrease volume of local anesthetic agents used and higher success rate. Patients and methods: Ninety-three patients was randomly allocated into one of three equal studies, each group 31 patients. All groups received SCB 20 ml (10ml Bupivacaine 0.5% plus 10ml lidocaine 2%). Group A received ISB 20ml, group B 14ml, and group C received 8ml Hypothesis and Study Objective: Procedures require anesthesia of entire length of the arm should have combined ISB and SCB to ensure high success rate. But dual block requires a high dose of local anesthetic. In our study, we don't need to give a full dose of local anesthetic in Interscalene nerve block as US help to visualize all trunks so we need the only injection of local anesthetics toward C5 and C6 aiming to block branches that may be escaped from supraclavicular nerve block. The aim of this study is to evaluate the efficacy of different volumes of local anesthetics in the ultrasound-guided Combined Interscalene-Supraclavicular Block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/01/2014
Actual trial start date 05/04/2015
Anticipated date of last follow up 06/04/2015
Actual Last follow-up date 06/04/2015
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 93
Recruitment status Stopped early/ terminated
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 Patients was randomly allocated into one of three equal study groups using EXCEL 2010 (Microsoft Corp. U.S.A.). The randomization sequences was concealed in opaque sealed envelopes that was kept by the senior anesthesia staff. The envelope was opened at the beginning of the operation before initiation of the block. Patients was randomly allocated into one of three equal study groups using EXCEL 2010 (Microsoft Corp. U.S.A.). The randomization sequences was concealed in opaque sealed envelopes that was kept by the senior anesthesia staff. The envelope was opened at the beginning of the operation before initiation of the block. Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group combined supraclaviculare block and inerscalene block for humoral fracture 20ml bupivacain plus 20 ml lidocaine half in SCB and second half ISB once The patient was placed in supine position with the head turned 45 degrees to the contralateral side. First, for the safety of block to avoid intraneural injection we performed SCB before ISB as the patient can feel any pain or the injection pressure while performing both blocks. For the ultrasound-guided supraclavicular block, an ultrasound machine (Mindray M7) and a 12 MHz linear type probe were 31 Active-Treatment of Control Group
Experimental Group combined supraclaviculare block and inerscalene block for humoral fracture received SCB with 20ml (10ml Bupivacaine 0.5% plus 10ml lidocaine 2%) and ISB with 15ml (7.5ml Bupivacaine 0.5% plus 7.5ml lidocaine 2%). once The patient was placed in supine position with the head turned 45 degrees to the contralateral side. First, for the safety of block to avoid intraneural injection we performed SCB before ISB as the patient can feel any pain or the injection pressure while performing both blocks. For the ultrasound-guided supraclavicular block, an ultrasound machine (Mindray M7) and a 12 MHz linear type probe were 31 Active-Treatment of Control Group
Experimental Group combined supraclaviculare block and inerscalene block for humoral fracture received SCB with 20ml (10ml Bupivacaine 0.5% plus 10ml lidocaine 2%) and ISB with 10ml (5ml Bupivacaine 0.5% plus 5ml lidocaine 2%). once The patient was placed in supine position with the head turned 45 degrees to the contralateral side. First, for the safety of block to avoid intraneural injection we performed SCB before ISB as the patient can feel any pain or the injection pressure while performing both blocks. For the ultrasound-guided supraclavicular block, an ultrasound machine (Mindray M7) and a 12 MHz linear type probe were 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I, II patients of both sexes, 18-55 years old, underwent fixation of traumatic humeral fracture requires anesthesia to the entire length of the arm was included in the study after obtaining written informed consent patient with neurological deficits involving upper limb, bleeding tendency, anticoagulation therapy, patients with allergy to local anaesthetics, local infection at the injection site, patients on sedative or antipsychotic drugs and body mass index (BMI) > 35. 18 Year(s) 55 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 02/11/2013 Anesthesia department Kasr Elany hospital
Ethics Committee Address
Street address City Postal code Country
Elmanial Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome no need of high volume of local anesthetic in combined SCB and ISB to cover the entire length of the arm. adequate level of anesthesia during surgery and for postoperative analgesia
Secondary Outcome changes in hemodynamics, respiratory rate, and oxygen saturation during surgery and 24h after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university Kasr Elaani Elmanial Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Mohamed Adly Elramely Nasr city Cairo Egypt Charities/Societies/Foundation
Primary Sponsor Mohamed Mohamed Abdelhaq zahraa elmaadi Cairo 11435 Egypt Funding Agency
Secondary Sponsor Ahmed Abdelaal Ahmed Mahmoud Cairo Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohamed Abdelhaq zahraa elmaadi Cairo 11435 Egypt
Mohamed Adly Elramely Cairo Egypt
Ahmed Abdelaal Ahmed Mahmoud Nasr city Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdelhaq mohamedabdelhaq76@hotmail.com 01000053764 18 zahraa elmaadi 7th district
City Postal code Country Position/Affiliation
Cairo 11435 Egypt Lecturer of anesthesiology, faculty of medicine, Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Adly Elramely mramely@hotmail.com 01002077703 Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesiology, National Cancer Institute, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdelaal Ahmed Mahmoud Carnitin7@hotmail.com 01113308866
City Postal code Country Position/Affiliation
Nasr city Egypt Assistant professor of anesthesiology, faculty of medicine, Bani-Suef University.
REPORTING
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