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CTRI Number  CTRI/2017/09/009756 [Registered on: 13/09/2017] Trial Registered Retrospectively
Last Modified On: 11/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare two methods for making hand pain free before operation 
Scientific Title of Study   Comparison between two approaches for ultrasound guided infraclavicular block in upper limb surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandni sinha 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia, AIIMS 
Address  Faculty room, OT complex, 3rd floor, Department of anaesthesia, AIIMS, Patna

Patna
BIHAR
801505
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandni Sinha 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia, AIIMS 
Address  Faculty room,Department of Anaesthesia, OT complex, 3rd floor, , AIIMS, Patna

Patna
BIHAR
801505
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandni Sinha 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  Faculty room, OT complex, 3rd floor, Department of Anaesthesia, AIIMS, Patna

Patna
BIHAR
801505
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Patna 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Phulwarisharif, Patna, Bihar 
Type of Sponsor  Research institution and hospital 
 
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 Chandni Sinha  All India Institute of Medical Sciences, Patna  OT Complex,Department of Anesthesia, 3rd floor, PMR Building
Patna
BIHAR 
7250333148

chandni.doc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical study(human studies)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HEALTHY ASA I/II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  classical approach  classical approach of needle placement 
Intervention  retroclavicular approach   retroclavicular approach of needle placement 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I/ II undergoing upper limb surgeries 
 
ExclusionCriteria 
Details  age less than 18 years,
2. inability to provide informed written consent,
4. refusal of regional anesthesia,
5. Contraindications to regional anesthesia (local skin infection, coagulopathy, shoulder or upper chest deformity,
6. severe respiratory disease,
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
visibility of the block needle  0 minutes(at the time of block) 
 
Secondary Outcome  
Outcome  TimePoints 
1.needling time
2. axillary artery depth
3 operator satisfaction:
4. surgeons satisfaction
5. block success:  
1. at the time of block
2.at the time of block
3. at the end of procedure
4. at the end of procedure
5.30 minutes after procedure
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2016 
Date of Study Completion (India) 08/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Ultrasound guided infraclavicular block has a success rate similar to axillary or supraclavicular approaches,it can be technically challenging due to its depth.  Needle visibility can be difficult, even due to its steep angulation, potentially increasing needling time. Superficially and at a distance from the neurovascular bundle, visibility is good, but image attenuation as critical structures are approached may degrade the view. Similarly, the infraclavicular block has advantages over axillary or supraclavicular blocks because it allows catheter placement with  Thus, an infraclavicular approach with better needle visibility may be of benefit. The novel retroclavicular block is a variant of the coracoids approach. The needle insertion point is posterior to the clavicle instead of inferior to it. This allows an almost perpendicular alignment of the ultrasound (US) beam and needle shaft. Because the angle of incidence of the US beam is a major determinant of reflection needle visibility is enhanced. If the needle tip is clearly visible, patient safety could be enhanced by avoidance of unintentional contact with the neurovascular bundle.

Though few case series have been published using this new retroclavicular approach, no studies have been done comparing it with retroclavicular approach. Hence , we plan to do this single blinded study comparing both these techniques in the following aspects:

PRIMARY OUTCOME:

1.      Block success rate

SECONDARY OUTCOME

1.      Needle visibility

2.      Time for procedure

3.      Patient comfort and satisfaction

4.      Axillary artery depth

5.      Operator comfort

6.      Rate of complications

MATERIALS AND METHOD

This single blind, prospective study will be done over a period of 1 year, recruiting 30 patients in each group

INCLUSION CRITERIA

1.      ASA I/ II patients undergoing distal arm, forearm, hand orthopaedic procedures

2.      Age: 18-60 years

3.      BMI: 18-24 kg/m2

          EXCLUSION CRITERIA

1.         age less than 18 years,

2.        inability to provide informed written consent,

4.       refusal of regional anesthesia,

5.      Contraindications to regional anesthesia (local skin infection, coagulopathy, shoulder or upper chest deformity,

6.      severe respiratory disease,

7.      preexisting neurological deficit in the ipsilateral arm,

8.      known allergy to local anesthetics

On arrival in the induction room, standard ASA monitoring will be applied and a 20-gauge intravenous catheter be inserted in the controlateral arm. Intravenous midazolam 1 to 2 mg will be given based on patient preference. The patients will be given infraclavicular block  according to computer generated random numbers by either of the two techniques.

CLASSICAL CORACOID APPROACH

The patient will then placed in a supine position, with the torso elevated to about 30 degrees and head facing away. A high-frequency linear US probe (6–15 Hz Sonosite Turbo M) will be placed parasagittally just medial to the coracoids process and caudal from the clavicle. Short-axis visualization of the axillary vessels and of the cords will then obtained by the coracoid approach.  At this time, the lung and second rib will also be visualized. At this point, needle will be inserted cranial to the probe and using the in plane technique 20 cc of 0.5% levobupivicaine will be deposited around the axillary artery in a U shaped fashion.

 

RETROCLAVICULAR TECHNIQUE

The patient will then placed in a supine position, with the torso elevated to about 30 degrees and head facing away. A high-frequency linear US probe (6–15 Hz Sonosite Turbo M) will be placed parasagittally just medial to the coracoids process and caudal from the clavicle. Short-axis visualization of the axillary vessels and of the cords will then obtained by the coracoid approach.  At this time, the lung and second rib will also be visualized. While holding the probe, the needle insertion point will be found by palpating the supraclavicular fossa, just medial to the shoulder at a point sufficiently posterior to the clavicle (generally 1–2 cm depending on morphology) and medial to the trapezius muscle insertion point on the clavicle (Fig. 1). If the fossa is depressible, the insertion point was sometimes found needle will need to clear the clavicle and stay parallel to the US probe to avoid any posterior angling. From this finger position, probe rotation and alignment with the palpating finger will be perfectly achieved while keeping the axillary vessels in the short axis. Once probe rotation achieves finger-probe alignment, the needle will now aim more toward the anterior axillary line than with the classic coracoid approach.

The probe will then applied using a sterile technique and, after local skin anesthesia, a 100-mm 18-gauge echogenic needle (PajunkMedizintechnik, Geisingen, Germany) will be  inserted and advanced at an angle strictly parallel to the probe and strictly in-plane. An initial blind zone measuring 3 to 4 cm in general, which corresponds to the acoustic shadow of the clavicle, was first passed through. For safety purposes, this length will  be evaluated by checking the surface distance between the probe and initial insertion point. Once the blind zone is crossed, correct in-plane alignment should enable a precise view of the needle shaft and, most importantly, the tip as it advances toward the neurovascular bundle. If the initial puncture point is correct and the angle of penetration is parallel to the US probe, the shaft should point to the posterior wall of the axillary artery. Hydrodissection will be used for the safe and efficient injection of the local anesthetic bolus posterior to the axillary artery. Twenty milliliters of levobupivicaine 0.5% will be injected incrementally, slightly adjusting the needle tip to obtain a U-shaped distribution of local anesthetic around the axillary artery. Blocks will be performed by anesthesiologists experienced in US-guided regional anesthesia.

Immediately after block completion, patients will be asked to rate their discomfort associated with the procedure using a 10-cm visual analog scale (0 = no pain, 10 = worst pain imaginable).

Block assessment will be performed by an independent research assistant 10, 20, and 30 minutes after the bolus is completed. Sensory loss will be assessed in the territory of the radial (lateral aspect of the dorsum of the hand), median (volar aspect of the thumb), ulnar (volar aspect of the fifth finger), musculocutaneous (lateral aspect of the forearm), and medial cutaneous nerve of the forearm (medial aspect of the forearm) distributions using a 3-point score, where 0 = normal sensation, 1 = diminished sensation to pinprick (hypoesthesia), and 2 = loss of sensation to pinprick (analgesia).Motor function will  also tested (0 = normal strength, 1 = weakness, 2 = paralysis) for the radial (thumb abduction), median (thumb opposition), ulnar (thumb adduction), and musculocutaneous (elbow flexion) nerves. Block success will be defined as a sensory score of 10 at 30 minutes. Needling time will be defined as the time from the beginning of skin anesthesia until the end of levobupivicaine injection. Procedures

will be videotaped and reviewed after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = very good) and to record the depth of the axillary artery.

Also noted will be the incidence of needle-induced paresthesia, vascular puncture, Horner syndrome, dyspnea, and symptoms of local anesthetic toxicity. To rule out pneumothorax, every patient will have

posteroanterior and lateral chest x-ray before discharge, which will be read by an independent radiologist. 48 hours after the surgery the patients were asked to rate their satisfaction with the anesthesia experience on a 10-point scale (0 = totally unsatisfied, 10 = totally satisfied)

and were questioned about possible complications (eg, residual paresthesia, hematoma, signs of infection, dyspnea).

 

 

 

 

 

 

 

 

 

 

 

PROFORMA

Name:                                         age:                                        sex:                                                               IP no

BMI:                                                             Surgery:

 

 

1.        block successful:

2.        needling time:

3.        operator satisfaction:

4.        surgeons satisfaction

5.        patients satisfaction

6.        needle visibility:

7.        axillary artery depth

8.        complications:   dyspnoea/ pneumothorax/ vessel puncture

 

 

 

 
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