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CTRI Number  CTRI/2025/01/079412 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Comparison to assess the success rate in view of block performance time,onset of sensory blockade and motor blockage in Lateral Sagittal and Costoclavicular Approaches in infraclavicular block using ultrasound in below elbow surgery 
Scientific Title of Study   An observation study to assess the success rate in view of block performance time,onset of sensory blockade and motor blockage in Lateral Sagittal and Costoclavicular Approaches in infraclavicular block using ultrasound in below elbow surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaibhavi Hajariwala 
Designation  Professor 
Affiliation  Shree krishna Hospital,karamsad 
Address  Department of Anaesthesiology Shree Krishna Hospital, Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand Anand GUJARAT 388325 India

Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaibhavi Hajariwala 
Designation  Professor 
Affiliation  Shree krishna Hospital,karamsad 
Address  Department of Anaesthesiology Shree Krishna Hospital, Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand Anand GUJARAT 388325 India

Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Bhumika patel 
Designation  Resident Doctor  
Affiliation  Pramukh Swami Medical College 
Address  Department of Anaesthesiology Shree Krishna Hospital, Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand Anand GUJARAT 388325 India

Anand
GUJARAT
388325
India 
Phone  7490041222  
Fax    
Email  patelbhumika655@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Shree Krishna Hospital, Gokal Nagar, Karamsad, Dist. Anand, Gujarat, India 388325  
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  Shree Krishna Hospital, Pramukh Swami Medical College, Gokal Nagar, Karamsad, Dist. Anand  
Type of Sponsor  Private 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 Bhumika patel  Shree Krishna Hospital, karamsad   Department of Anaesthesiology ,Shree Krishna Hospital, Pramukh Swami Medical College, Gokal Nagar, Karamsad, Dist. Anand GUJARAT
Anand
GUJARAT 
7490041222

patelbhumika655@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2,bhaikaka university , karamsad, anand  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison between Costoclavicular Approach and lateral saggital approach in below elbow surgery with use of ultrasound   An ultrasound machine with 8-12MHZ linear probe with colour doppler will be utilized, After application of standard anesthesia monitors, the block will be performed with the use of 23gauge spinal needle. Both blocks will be performed with the patients in the supine position and under aseptic conditions; 0.5% ropivacaine 20ml will be used as the LA with 8mg of dexamethasone as an additive, total 22ml volume will be use. The in-plane technique will be used for both approaches of infraclavicular block.  
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients aged 18-65 years who will be scheduled for forearm and hand surgery with the American Society of Anesthesiologist (ASA) grades I-III and will give written informed consent will be enrolled in this study 
 
ExclusionCriteria 
Details  obesity, Regional anesthesia contraindications, Patients refusal to participate, infection over block area, A history of hypersensitivity to local anesthesia drugs, Psychiatric disorder, bleeding disorder or coagulopathy, preexisting neurological deficit, requirement of conversion to general anesthesia due to inadequate block 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the success rate in view of block performance time,onset of sensory blockade and motor blockage in Lateral Sagittal and Costoclavicular Approaches in infraclavicular block using ultrasound in below elbow surgery.  0 min to 30 min 
 
Secondary Outcome  
Outcome  TimePoints 
1) Assess the intensity of sensory block (anaesthesia of four terminal nerve) and motor block, surgical effectiveness in lateral sagittal and costoclavicular approaches in infraclavicular brachial plexus block guided ultrasound
2) Compare the block performance times to map the spread of sensory block, compare motor block to evaluate the safety of both approaches (incidences of adverse events and complications), to assess patients’ acceptance of blocking procedure and surgeon’s satisfation .
 
0 min to end of surgery 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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/ Phase 4 
Date of First Enrollment (India)   12/11/2025 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After obtaining ethical committee approval and obtaining written and informed consent, patients of ASA (American society of anesthesia) I to ASA III physical status who is undergoing for elective orthopedic surgery at the level below the elbow and distally will be recruited to participate in the study

It is a randomization study. sample size is 134 of this clinical study so each group sample is (67).

So participants will be allocated to either A or B group, based on randomization plan using Winpepi software.

Pre anesthetic check up will be carried out in all patients with detailed clinical history, general history, as well as general and systemic examination. After checking the overnight fasting of 6-8hours, arrival to anesthetic room, an Iv line, a blood pressure cuff and pulse oximetry probe were attached to non operated arm. All block will be performed by the  2nd and 3rd year resident with experience of performing 10-15 blocks using ultrasound under the supervision of an experienced anesthesiologist. All block will be  performed by the first anesthesiologist who will take no further part in that case management. Sedation will be administered until the evaluation of the block is completed if required.

 

Samples would consist of patients undergoing upper limb surgeries in SHREE KRISHNA

HOSPITAL, KARAMSAD, ANAND

 

Method:

An ultrasound machine with 8-12MHZ linear probe with color doppler will be utilized, After application of standard anesthesia monitors, the block will be performed with the use of 23gauge  spinal needle.

Both blocks will be performed with the patients in the supine position and under aseptic conditions; 0.5% ropivacaine 20ml  will be used as the LA with 8mg of dexamethasone as an additive, total 22ml volume will be use. The in-plane technique will be used for both blocks.

 

Lateral sagittal approach (Group LS) The patients’ ipsilateral arm will be abducted for the scan. The head was turned slightly to the contralateral side for the ICB. The US probe will be positioned medial to the coracoid process in the sagittal plane in the infraclavicular region, and three cords of the brachial plexus will be then visualized. After negative aspiration for blood to exclude any inadvertent intravascular needle placement, and with the needle tip in its target location, an in-plane technique will be used to administer 20ml 0f ropivacaine (0.5%) with 2ml of inj dexamethasone total 22 ml around the posterior cord (8 mL), lateral cord (8 mL), and medial cord (6 mL)

 Costoclavicular approach (Group CC) The US probe will be positioned parallel to the clavicle in the midclavicular area, tilted toward the cephalad and the axillary artery, and the three cords were visualized. If the cephalic vein or thoraco acromial artery will be visualized, the US probe  will be  slightly tilted toward the cephalad. After negative aspiration for blood, an in plane technique will be used to advance the needle from a lateral to the medial direction, and 20 mL of ropivacaine (0.5%) with 2ml of inj dexamethasone total 22ml will be administered to the center of the three cords

The onset of sensory and motor blockade, patient and surgeon’s satisfaction,  and occurrence of any side effects in both groups will be assessed. The onset of sensory block is defined as the time elapsed between injection of drug and complete loss of pinprick sensation. Where onset of motor blockade is  outlined as the time elapsed from injection of drug to complete motor blockade.

The onset and degree of sensory and motor block will be observed every 5 mins for 30 mins till complete blockade is achieved. If after 30 mins complete sensory blockade was not achieved and patient perceived pain then it was taken as a failed block then general anesthesia will be administered and cases which will be converted in general anesthesia will be excluded from the study

The sensory score will be assessed using needle prick method by testing five individual nerves Such as the median nerve, radial nerve, ulnar nerve, musculocutaneous nerve and the medial cutaneous of the forearm. For musculocutaneous nerve sensation will be checked over the skin of the lateral part of the forearm, for the medial cutaneous of forearm - anterior and medial aspect of the forearm, for ulnar nerve skin over hypothenar eminence, skin over medial third of dorsum of hand and medial and half fingers. For the radial nerve, the lower posterior arm, posterior forearm -lateral 2/3 of dorsum of hand, for the median nerve sensation will be checked over thenar eminence, lateral  three and half finger  of palm of hand.

  Scoring adapted for each nerve

           Score 2   - No pain ,no touch sensation

           Score 1  - Touch sensation only

           Score 0  - Sharp pain

 

The quality of motor blockade will be observed on a four point scale

          Score 3   - No movements in the entire upper limb

          Score 2   - Flexion and extension in hand but not In the arm

          Score 1   - Flexion and extension in both the hand and arm against gravity but not against resistance

          Score 0   - Flexion and extension in both hand and arm against resistance

The patient will be  asked for their satisfaction level during the performance of block and surgery by a five point assessment scale

          Score 5 Very satisfied

          Score 4 Satisfied

          Score 3 Neither satisfied/dissatisfied

          Score 2 Dissatisfied

          Score 1 Very dissatisfied       

Surgeon’s satisfaction will be assessed with  likert score

          Score 5 Very satisfied

          Score 4 Satisfied

          Score 3 Neither satisfied/dissatisfied

          Score 2 Dissatisfied

          Score 1 Very dissatisfied  

 

 The block performance time was defined as the time interval from placement of ultrasound probe cation of Sono anatomy to the complete administration of  drug volume.

 

In the immediate post operative period, patients will be asked about the occurrence and the intensity of surgical pain. All patients will be assessed post operatively and questioned about complications like (bruise/swelling at block site, chest pain/breathing difficulty, nausea, vomiting, muscle weakness in the operated extremity not related to site of operation).


If patient developed any of above mentioned complication it will managed accordingly,if swelling will developed cold compression with analgesic and antinflamatory will be given.If a hematoma forms, its prompt evacuation may significantly reduce symptoms and will prevent development of compartment syndrome

If chest pain or breathing difficulties developed it will be investigated to see whether patient has developed any condition like pneumothorax  will be confirmed with xray chest ,and if present  will be treated accordingly.

Inj ondansetron 4mg iv will be given if patient developed post procedure nausea or vomiting

If any muscle weakness will develop  it will be reassessed post operatively for brachial plexus injury if any will be further investigated and will be treated accordingly.


 
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