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CTRI Number  CTRI/2023/03/050744 [Registered on: 15/03/2023] Trial Registered Prospectively
Last Modified On: 01/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare efficacy of levobupivacaine alone or alongwith lignocaine with adrenaline in ultrasound guided supraclavicular block for upper limb surgeries in reducing pain and quality of recovery afterwards. 
Scientific Title of Study   Comparison of Perioperative Analgesic Efficacy and Quality of recovery on addition of lignocaine with adrenaline to Levobupivacaine in Ultrasound Guided Supraclavicular Block for Upper Limb Orthopaedic Surgeries: A Randomised Control Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti 
Designation  DNB Resident  
Affiliation  BPS GMC Khanpur 
Address  Main OT complex, first floor , main hospital building, Bhagat Phool Singh Govt medical college , Khanpur

Sonipat
HARYANA
131305
India 
Phone  9711764546  
Fax    
Email  dr.jyotilh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenu Agrawal  
Designation  Professor  
Affiliation  BPS GMC Khanpur 
Address  Room no 7, Main OT complex, first floor, main hospital building, Bhagat Phool Singh Govt medical college, Khanpur

Sonipat
HARYANA
131305
India 
Phone  9467823780  
Fax    
Email  meenu297@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Jyoti 
Designation  DNB Resident  
Affiliation  BPS GMC Khanpur 
Address  Main OT complex, first floor, main hospital building, Bhagat Phool Singh Govt medical college, Khanpur

Sonipat
HARYANA
131305
India 
Phone  9711764546  
Fax    
Email  dr.jyotilh@gmail.com  
 
Source of Monetary or Material Support  
Government medical college  
 
Primary Sponsor  
Name  Government medical college  
Address  BPS GMC KHANPUR,Sonipat, Haryana 131305 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr JYOTI  Bhagat phool Singh Government Medical College   Operation theatre number 2, Main OT complex, Department of anaesthesiology First floor, main hospital building BPS GMC KHANPUR
Sonipat
HARYANA 		 9711764546

drjyotilh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S529||Unspecified fracture of forearm, (2) ICD-10 Condition: S520||Fracture of upper end of ulna, (3) ICD-10 Condition: S521||Fracture of upper end of radius, (4) ICD-10 Condition: S522||Fracture of shaft of ulna, (5) ICD-10 Condition: S523||Fracture of shaft of radius, (6) ICD-10 Condition: S525||Fracture of lower end of radius, (7) ICD-10 Condition: S526||Fracture of lower end of ulna, (8) ICD-10 Condition: S424||Fracture of lower end of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine and lignocaine with adrenaline   Supraclavicular block given using 14 ml of Levobupivacaine (0.5%), 14 ml of lignocaine with adrenaline and 2 ml of normal saline  
Comparator Agent  Levobupivacaine only   Supraclavicular block given using 28 ml of levobupivaine (0.5%) and 2 ml of normal saline . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I , II, III 
 
ExclusionCriteria 
Details  Infection at local sites, hypersensitivity to Local Anaesthetic drugs, per existing neuropathy, bleeding disorders,pregnancy, any hepatic , renal,neurological,psychiatric or neuromuscular diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 To measure first rescue analgesia
2 to measure total analgesic requirement  		 1) time at which first rescue analgesia given will be recorded.
2) total analgesia required in 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1)to compare QoR score in both groups.
2) to blockade characteristics
3) conversion rate to general anaesthesia.
4) peri operative hemodynamic and side effects. 		 1) QoR-15 score to be compared after 24 hrs of blockade.
2)sensory and motor blockade will be assessed every 1 min for 15 mins.
3)patient complaining of pain in any one nerve distribution even after 30 mins of administration of block.
4)Vital monitoring and side effect will noted every 5 mins for 40 mins
And thereafter every 10 mins for 90 mins. Post operative monitoring will be done hrly for 6 hrs and then at 8hr, 12hr, 18hr and 24hr interval.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Current study is to research the effect of lignocaine as an adjuvant to levobupivacaine for advancement of scientific knowledge.

The aim of this study is to compare the perioperative efficacy and recovery quality of ultrasound guided supraclavicular block  administered using levobupivacaine with or without lignocaine with adrenaline for conduct of upper limb surgeries. Patients will be randomly divided into two groups (LLB and LL) with 40 patients in each group. The nerve bundle will be identified and infiltrated with the local anesthetic after negative aspiration for blood and no intraneural spread as visualized with ultrasound. Group LB will receive  28 mL of 0.5% levobupivacaine and 2 mL of normal saline  while the Group LLB will receive 14 ml of 0.5% levobupivacaine,14 ml of lignocaine with adrenaline  and 2 ml of normal saline making a total 30 ml of anestheticsolution. Patients will be observed for onset and duration of spinal and motor blockade in both the groups. The hemodynamic changes and side effects if any, would also be noted and compared amongst two groups. Postoperative analgesia requirement with rescue analgesia using injection Paracetamol 1gm intravenously.

 
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