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CTRI Number  CTRI/2023/06/053528 [Registered on: 05/06/2023] Trial Registered Prospectively
Last Modified On: 04/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of two approaches of infraclavicular brachial plexus block for below elbow fractures under USG and PNS guidance 
Scientific Title of Study   Comparative evaluation of two approaches of infraclavicular brachial plexus block for below elbow orthopaedic surgeries under dual guidance of USG and PNS- A randomised single blinded clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zalak Patel 
Designation  Resident Doctor 
Affiliation  GMERS medical college and hospital, Gotri, Vadodara 
Address  Department of anaesthesiology, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  7567296079  
Fax    
Email  drzpatel03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavesh Dalwadi 
Designation  Associate Professor, Department of anaesthesiology, GMERS Gotri, Vadodara 
Affiliation  GMERS medical college and hospital, Gotri, Vadodara 
Address  Old TB Campus,Department of anaesthesiology, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  6354210984  
Fax    
Email  bhaveshkdalwadi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhavesh Dalwadi 
Designation  Associate Professor, Department of anaesthesiology, GMERS Gotri, Vadodara 
Affiliation  GMERS medical college and hospital, Gotri, Vadodara 
Address  Old TB Campus,Department of anaesthesiology, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  6354210984  
Fax    
Email  bhaveshkdalwadi@gmail.com  
 
Source of Monetary or Material Support  
GMERS Medical college and hospital, Gotri, Vadodara 
 
Primary Sponsor  
Name  GMERS Medical college and Hospital 
Address  Old TB Campus, Gotri main Road, Gotri, Vadodara 
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 Zalak Patel  GMERS Medical college and hospital  Orthopaedic operation theatre,Old TB campus,GMERS medical college and hospital, Gotri main Road, Gotri, Vadodara
Vadodara
GUJARAT 
7567296079

drzpatel03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC GMERS MEdical college and hospital, Gotri, Vadodara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (2) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (3) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, (4) ICD-10 Condition: S52||Fracture of forearm, (5) ICD-10 Condition: S62||Fracture at wrist and hand level, (6) ICD-10 Condition: S529||Unspecified fracture of forearm, (7) ICD-10 Condition: S629||Unspecified fracture of wrist andhand,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Classical infraclavicular block  USG and PNS guided CIB under all aseptic precautions with injection Levobupivcaine 0.5% 15ml and injection lignocaine 2% 15ml -Procedure time - From the contact of the ultrasound probe with the patient to the removal of needle 
Comparator Agent  Retroclavicular block  USG and PNS guided RCB under all aseptic precautions with injection Levobupivcaine 0.5% 15ml and injection lignocaine 2% 15ml Procedure time - From the contact of the ultrasound probe with the patient to the removal of needle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Age: 18-60 years
2)BMI: <30 kg/m2
3) American society of anaesthesia grading: I and II
4) Forearm, hand and wrist fractures  
 
ExclusionCriteria 
Details  1) Patient refusal
2) Allergy to LA
3) Local site infection
4) Anatomical distortion of clavicle
5) Polytrauma
6) Pre-existing neurological deficit
7) Pre-existing systemic illness like uncontrolled hypertension, ischemic heart disease, severe pulmonary disease, renal or hepatic dysfunction,sepsis
8) Surgeries requiring tourniquet
9) Coagulopathy
10) Patients with hearing disability, dementia, psychiatric illness or mentally challenged, having language barrier, who cannot express scoring system used in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the procedure time between both the groups   -Procedure time (at baseline) - From the contact of the ultrasound probe with the patient to the removal of needle
 
 
Secondary Outcome  
Outcome  TimePoints 
Needle visibility  Whole needle with tip-3 Needle course partially seen-2 Only needle impression-1
 
Needle passes  During the procedure, number of times the needle required redirection or retraction of at least 10 mm for ≥2 times will be recorded as an “additional pass”. 
To compare success rates   Block success: When a minimal composite sensorimotor score of 14 is achieved, the surgeon can proceed with surgery.

Block failure: Patients requiring supplemental analgesia, additional LA, general anaesthesia or having composite sensorimotor score 14 will be considered as a failure of study. 
To compare onset of sensory & motor block in both groups   After LA injection, sensory & motor blockade will be evaluated by an observer every 5 min, until 30 min.  
Complications  Complications if occur any will be observed intra-operative period 
 
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)   14/06/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM

To compare retroclavicular and classical approaches to infraclavicular brachial plexus block for providing anaesthesia for forearm surgeries under dual guidance of ultrasound and peripheral nerve stimulator.

 

OBJECTIVES

Primary objective: 

To compare the procedure time between both the groups

Secondary objectives:

      Needle visibility

      Number of needle passes

      Success rate

     Onset and duration of sensory and motor block

     Complications if any

                                                         

METHODLOGY

Ethical consideration- The principles of Helsinki declaration will be followed throughout the study. This study will be conducted after getting approval from local Ethical Committee of GMERS Medical College and Hospital, Gotri, Vadodara. It will be registered under clinical trial registry of India. Written and informed consent will be taken from all participants. Data collected will be kept confidential.

Study design- Randomised controlled, single blinded study

Study setting- Tertiary care teaching hospital (GMERS medical college and hospital, Gotri, Vadodara)

Study duration- approximately 1 year

Study population- Total 80 patients with below elbow trauma undergoing orthopaedic surgeries of forearm, wrist and hand under regional anaesthesia.

Inclusion criteria:

Age:  18-60 years

BMI : < 25 kg/m2

American society of Anaesthesia grading : I and II

Exclusion criteria:

Patient refusal

Allergy to LA

Local site infection

Anatomical distortion of clavicle

Polytrauma

Pre-existing neurological deficit

Pre-existing systemic illness like uncontrolled hypertension or ischemic heart disease, severe pulmonary disease, renal or hepatic dysfunction, sepsis

Surgeries requiring tourniquet

Coagulopathy

Patients with hearing disability, dementia, psychiatric illness or mentally challenged or having a language barrier, who cannot express scoring system used in the study


STUDY PROCEDURE

Randomization and allocation :

Patients will be randomly assigned to either CIB (C) or RCB (R) group in 1:1 ratio using predetermined computer generated randomisation table. To ensure concealment, sequentially numbered, opaque and sealed envelopes will be used. Only the research assistant will have access to the envelopes. A research assistant, resident or Anaesthesiology department staff member will be responsible for assessing participant eligibility and recruitment. 

Intervention

Patients will be randomized in two groups:

Group C (n=40): Classical approach of ICB

Group R (n=40): Retroclavicular approach of ICB

After a detailed Pre-Anaesthetic examination and taking patient in a pre-operative room, an 18 or 20 gauge intravenous catheter will be secured in upper limb contralateral to surgical upper limb and intravenous pre-medication (0.03 mg/kg midazolam) will be administered to all patients. Supplemental oxygen (by nasal cannula at 4L/min) and standard ASA monitors will be applied throughout the procedure.

All blocks will be performed under aseptic and antiseptic precautions and after local anaesthesia infiltration of skin (2 or 3 ml of inj. Lignocaine 1%). Inj. Levobupivacaine 0.5%- 15 ml (2 mg/kg) and inj. Lignocaine 0.2%- 15ml (5 mg/kg) will be given to all patients.


USG+ PNS guided Classical approach

 

With the patient in the proper position with arm abducted to 90 degrees and the elbow flexed, the skin will be disinfected. After identifying coracoid process, high-frequency linear transducer is positioned just medial to the coracoid process and inferior to the clavicle in the parasagittal plane, scanning medially and laterally to identify the axillary artery. Once the artery has been identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery.The needle then will be inserted in-plane from the cephalad end of the probe, with the insertion point just inferior to the clavicle. The needle, aimed toward the posterior aspect of the axillary artery and passes through the pectoralis major and minor muscles. Nerve stimulation with long (80-100mm) PNS needle will be used concurrently (0.5–0.8 mA, 0.1 m sec), the first motor response is often from the lateral cord (either elbow flexion or finger flexion). As the needle is advanced further beneath the artery, a posterior cord motor response may appear (finger and wrist extension). After careful aspiration, 1–2 mL of local anaesthetic will be injected to confirm proper needle placement and spread. The total drug volume should spread cephalad and caudal to cover the lateral and medial cords, respectively.


USG + PNS guided Retroclavicular approach

 

The technique will be performed with the patient supine and the arm adducted. A high-frequency linear ultrasound transducer will be placed inferiorly to the clavicle just medially to the coracoid process in the parasagittal plane such that the axillary vessels and cords of the brachial plexus are viewed in cross-section. In this short axis view, the lateral cord appears in the anterocranial position, posterior cord in the posterocranial position, and median cord in the posterocaudal position. A needle insertion point is chosen in the supraclavicular fossa, between the clavicle and trapezius, so that the needle will pass behind the clavicle and enter the ultrasound image nearly parallel to the transducer (or perpendicular to the beam) and tip of the needle is directed near 5 or 6 o’clock position of axillary artery. A long (80-100mm) needle of PNS will be required given the distance from the supraclavicular fossa to the axillary artery.

In this technique, the US probe is initially angled towards the clavicle to identify the needle approaching from behind the clavicle.  After confirming with motor response as described in classical approach with PNS, 0.5% Levobupivacaine 15ml and 0.2% lignocaine 15ml will be given after negative aspiration. 


OUTCOME MEASURES-

Primary outcome:

Comparison of performance time (time interval from the contact of the ultrasound probe with the patient to appreciate axillary artery to removal of the block needle) of Classical and Retroclavicular approaches.

Secondary outcome:

          Needle visibility

         Needle passes

          To compare success rates ( patients requiring additional analgesia)

         To compare onset of sensory and motor block in both groups

     Complications 





 
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