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CTRI Number  CTRI/2023/06/054260 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 21/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF ROPIVACAINE (0.5%) AND LEVOBUPIVACAINE (0.5%) IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN UPPER LIMB ORTHOPAEDIC SURGERIES  
Scientific Title of Study   COMPARISON OF ROPIVACAINE (0.5%) AND LEVOBUPIVACAINE (0.5%) IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN UPPER LIMB ORTHOPAEDIC SURGERIES – A DOUBLE BLIND RANDOMISED CONTROL TRIAL 
Trial Acronym  Not applicable  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  YOGINI KELAWALA 
Designation  RESIDENT DOCTOR 
Affiliation  GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR 
Address  116, 364001ANAESTHESIA OPD, SIRT HOSPITAL, BHAVNAGAR
SIR T HOSPITAL, JAIL ROAD, BHAVNAGAR
Bhavnagar
GUJARAT
364001
India 
Phone  9586448984  
Fax    
Email  yk2482682@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHILPA DOSHI 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR 
Address  116, ANAESTHESIA OPD, SIRT HOSPITAL, BHAVNAGAR
SIR T HOSPITAL, JAIL ROAD, BHAVNAGAR
Bhavnagar
GUJARAT
364002
India 
Phone  9428810763  
Fax    
Email  drshilpadoshi@yahoo.in  
 
Details of Contact Person
Public Query  
Name  YOGINI KELAWALA 
Designation  RESIDENT DOCTOR 
Affiliation  GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR 
Address  116, ANAESTHESIA OPD, SIRT HOSPITAL, BHAVNAGAR
SIR T HOSPITAL, JAIL ROAD, BHAVNAGAR
Bhavnagar
GUJARAT
364001
India 
Phone  9586448984  
Fax    
Email  yk2482682@gmail.com  
 
Source of Monetary or Material Support  
Sir T General Hospital, Bhavnagar  
 
Primary Sponsor  
Name  YOGINI KELAWALA 
Address  116, ANAESTHEISA OPD, SIRT HOSPITAL, BHAVNAGAR 
Type of Sponsor  Other [Self] 
 
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 
YOGINI KELAWALA  SIR T General Hospital, Bhavnagar   ORTHOPAEDIC OT, SIR T HOSPITAL, BHAVNAGAR
Bhavnagar
GUJARAT 		 9586448984

yk2482682@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE, GOVERNMENT MEDICALCOLLEGE, BHAVNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S42||Fracture of shoulder and upper arm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LEVOBUPIVACAINE  Inj. Levobupivacaine hydrochloride(0.5%) Dose- 30cc Route of administration: Supraclavicular brachial plexus block Duration: 1 time intervention  
Intervention  ROPIVACAINE  Inj. Ropivacaine hydrochloride (0.5%) Dose: 30cc , Route of administration:Supraclavicular brachial plexus block Duration: 1 time intervention  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with ASA Grade I,II and III of either gender.
All patients undergoing elective and emergency upper limb orthopaedic surgeries.
Age group of 18 to 65 years.
Patient with body weight upto 80 kg.
 
 
ExclusionCriteria 
Details  Patient having hypersensitivity to the study drugs by taking history.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate onset of sensory block in both the groups.
To estimate duration of sensory block in both the groups.
To estimate onset of motor block in both the groups.
To estimate duration of motor block in both the groups.
To access time of rescue analgesia in both the groups.
 		 AT THE END OF 15 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To observe changes in HR,MAP, SpO2 in both the groups.
To compare side effects like hypotension, bradycardia, nausea, vomiting in both the groups.
 		 AT THE END OF 15 MONTHS 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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   Phase 3 
Date of First Enrollment (India)   30/06/2023 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   STUDY WILL BE PUBLISHED AFTER COMPLETION. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

•        Peripheral nerve block is particularly advantageous in case of prolonged orthopaedic, plastic reconstructive surgeries , emergency surgeries and in high risk patients.

•        Newer anaesthetic drugs like levobupivacaine and ropivacaine have fewer adverse effects on cardiovascular and central nervous system when compared with bupivacaine making them more advantageous in regional anaesthesia technique.

•        Ropivacaine , the S-enantiomer of S- 1-propyl -2’ ,6’ –pipecoloxylidide is an amino amide local anaesthetic agent. It is chemically similar to bupivacaine, butyl group being replaced by propyl group, produces similar sensory and motor blockade, with less cardiac and CNS toxicity compared to bupivacaine. [7]

•        Levobupivacaine is the S(-) enantiomer of racemic bupivacaine . R- and S- enantiomers of local anaesthetics have been demonstrated to have different affinity for different ion channels of sodium, potassium and calcium and this results in significant reduction in cardiac and central nervous system toxicity of S – enantiomer as compared with R-enantiomer.

 

Study Procedure

 

A prospective, randomized, double blind comparative study will be carried out after Institutional Review Board (IRB) approval and informed written consent of patient will be taken  in the Department of Anesthesiology, Sir T General Hospital, Govt. Medical College, Bhavnagar, Gujarat, India.

 

1st step: Preoperative evaluation will be done in all the study population with detailed case history, general examination, assessment of airway and evaluation of investigation.

 

2nd step: 94 patients will be randomised using computer generated random number sequence method in two groups.

 

•        Group R- Receiving  Inj. Ropivacaine hydrochloride (0.5%)30cc.

•        Group L- Receiving  Inj. Levobupivacaine hydrochloride(0.5%) 30cc.

•        Double blinding will be done by drawing lots labelled group-R and group-L and documenting their hospital number on the lot assigned.

 

 

3rd step: Brachial plexus block will be performed by supraclavicular approach.

 

4th step: Patients will be evaluated for motor and sensory blockade .The onset and duration of both motor and sensory blockade will be noted. Also the duration of analgesia will be noted in both groups.

 

5th step: Patients will be monitored for vital parameters (HR,MAP,SpO2) and complications ,if any(hypotension, bradycardia, nausea, vomiting).

6th step: Patient will be evaluated for rescue analgesia requirement .

 

METHODOLOGY

•        After written & informed consent from patient in vernacular language, approval from ethical committee, preoperative evaluation will be done in all the study population with detailed case history, general examination, assessment of airway and evaluation of investigation.

•        Randomisation will be done by single trained anaesthetist not involved in study.

•        The study drug will be prepared and coded by an anesthesiologist not involved in the study.

•        Senior anesthesiologist other than principal investigator will perform the brachial plexus block and PI  will be, responsible for monitoring of the patient.

•        Patient will be evaluated for onset and duration of sensory and motor blockade using the Hollmen scale and modified Bromage scale.

•        All data will be entered into master chart ,detailed analysis will be done and appropriate statistics will be carried out.

•        Preoperative evaluation will be done in all the study population with detailed case history, general examination, assessment of airway and evaluation of investigation.

•        Randomisation will be done by single trained anaesthetist not involved in study.

•        60 patients will be randomised using computer generated random number sequence method in two groups.

•        Group L- Receiving 0.5% Inj. Levobupivacaine hydrochloride 30cc

•        Group R- Receiving 0.5% Inj. Ropivacaine hydrochloride 30cc

•        Double blinding will be done by drawing lots labelled group-L and group-R and documenting their hospital number on the lot assigned.

•        After patient taking on operation table and monitor using pulse oximeter, ecg and non invasive blood pressure .

•        An intravenous access was secured using an in dwelling canula of appropriate size.

•        Brachial plexus block was performed by supraclavicular approach.

•        Patient will be positioned supine with head turned about 30 degree to contralateral side.

•        After palpating the interscalene groove and tracing it to most inferior point, which is just posterior to subclavian arterial pulse , the later can be felt in plane just medial to midpoint of clavicle.

•        The local infiltration with 2% 2cc Lignocaine will be done to minimize needle pain.

•        A 22G,50mm stimuplex needle with nerve stimulator will be directed just above and posterior to subclavian arterial pulse and will be directed caudally at a very flat angle against the skin. The needle will be advanced until flexion of finger will be noted.

•        If contraction will still be observed with intensity of stimulating current decreased to 0.5mA,then following protocol : Group –L will receive 30cc of 0.5% Inj. Levobupivacaine hydrochloride and Group –R will receive 30cc of 0.5% Inj. Ropivacaine hydrochloride.

•        Patient will be evaluated to determine loss of arm abduction (Deltoid sign as a sign of successive motor blockade).

•        Sensory block will be assessed by pin prick over surgical site.

•        Surgery will be allowed to begin 30minutes after successful block.

•        End of performing the injection will be taken as time zero.

•        Pain will be assess using Visual Analogue Scale(VAS),graded from 0 to 10.

•        Onset of sensory block: Time between end of performing injection to loss of  pinprick sensation.

•        Onset of motor block: Time required from completion of drug to loss of motor power.

•        Duration of sensory block: Time between onset of sensory block and return of dull pain and VAS<4.[5]

•        Duration of motor blockade: Time between onset of motor block and regained ability of patient to move fingers.

•        Duration of analgesia : Time between onset of action and onset of pain (VAS >4)and time when patient receive the first dose of rescue analgesia.

•        Rescue analgesia: Inj. Diclofenac 1.5 mg/kg iv.

•        Patient will be monitored for cardiovascular or CNS toxicity(changes in BP,HR, signs/symptoms of CNS stimulation).


 
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