FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065862 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of combining superficial cervical plexus block with clavipectoral fascial plane block or interscalene brachial plexus block using ultrasound machine with local anesthesia 0.375% ropivacaine for collar bone fracture surgeries 
Scientific Title of Study   A Prospective Randomized Controlled Comparative Study of Combining Ultrasound Guided Superficial Cervical Plexus Block with Clavipectoral Fascial plane Block and Interscalene Brachial Plexus Block using 0.375% Ropivacaine for Elective Clavicle Surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Muni Sruthi 
Designation  Post Graduate First Year 
Affiliation  Navodaya Medical College Hospital and Research Centre 
Address  Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur 584103

Raichur
KARNATAKA
584103
India 
Phone  8374521228  
Fax    
Email  sruthikota86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gowni Geetha 
Designation  Associate Professor 
Affiliation  Navodaya Medical College, Hospital and Research Centre 
Address  Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur 584103

Raichur
KARNATAKA
584103
India 
Phone  9353116870  
Fax    
Email  kumargowtham1994@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gowni Geetha 
Designation  Associate Professor 
Affiliation  Navodaya Medical College, Hospital and Research Centre 
Address  Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur 584103

Raichur
KARNATAKA
584103
India 
Phone  9353116870  
Fax    
Email  kumargowtham1994@gmail.com  
 
Source of Monetary or Material Support  
Navodaya Medical College Hospital and Research Centre, Raichur 584103 
 
Primary Sponsor  
Name  K MUNI SRUTHI 
Address  Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur 584103 
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 
Dr K Muni Sruthi  Navodaya Medical College Hospital and Research Centre  Operation theatre, Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur 584103
Raichur
KARNATAKA 
8374521228

sruthikota86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S420||Fracture of clavicle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Superficial cervical plexus block with clavipectoral fascial plane block using 0.375% Ropivacaine  Superficial cervical plexus block with 7ml of 0.375% Ropivacaine Clavipectoral fascial plane block with 10 ml of 0.375% Ropivacaine on either side of fracture Maximum dose of Ropivacaine being 3mg/kg. Route of administration is Ultrasound guided administration of local anaesthetic agents around the nerve  
Intervention  Superficial cervical plexus block with Interscalene brachial plexus block  Superficial cervical plexus block with 7ml of 0.375% Ropivacaine Interscalene brachial plexus block with 20 ml of 0.375% Ropivacaine Maximum dose of Ropivacaine being 3mg/kg Route of administration is Ultrasound guided administration of local anaesthetic agents around the nerve 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients belonging to American Society of Anaesthesiologists Physical Status I and II.
2. Patients undergoing elective surgery for clavicle fractures.  
 
ExclusionCriteria 
Details  1. Patients refusing for the procedure.
2. Patients with history of allergy, sensitivity or any kind of reactions to
local anesthetic agents.
3. Patients with coagulation abnormalities.
4. Patients with cardiovascular and cerebrovascular diseases.
5. Patients with infection at the injection site.
6. Patients with history of Chronic Obstructive Pulmonary Disease and
Pleural effusion. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The time at which the first use of rescue analgesic drug.
This will be assessed in the postoperative period after the surgery. 
Pain will be assessed using Pain Score : Visual Analogue Scale at 6th , 12th and 24th hour postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
The sensory effect of all the blocks will be assessed in three areas:
sternoclavicular joint,
mid clavicle, acromioclavicular joint preoperatively after giving block. 
The sensation will be assessed
immediately after giving block & also at 30th minute after giving block to check for the onset time. 
The motor effect of all the blocks will be assessed preoperatively after giving block at shoulder joint, elbow joint, wrist joint, metacarpophalangeal & interphalangeal joints of fingers  The motor effect will be assessed
immediately after giving block & also at 30th minute after giving block to check for the onset time. 
Diaphragm excursion measurement will be done during normal tidal volume breaths & deep breaths before giving
block preoperatively & also intraoperatively & also postoperatively 
Diaphragm excursion measurement will be assessed using Ultrasound in centimeters just before giving block as preblock value & at 30th minute after giving block & also at 4th hour after giving block 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/05/2024 
Date of Study Completion (India) 25/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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             The aim of my study is to compare the application of Ultrasound guided superficial cervical plexus block combined with clavipectoral fascial plane block or interscalene brachial plexus block in elective clavicle fractures using 0.375% Ropivacaine with respect to duration of analgesia and incidence of hemidiaphragmatic paresis or paralysis.          
          As institutional ethical committee approval obtained, written and informed consent will be taken from the patient. The study will be conducted in 100 patients between 18 to 60 years of age, ASA-I and ASA-II of either gender with fracture of clavicle electively posted for open reduction and internal fixation Patients will be randomly allocated into one of the following groups Group I and Group II using computer generated random number table 
          Group I: Patients in this group will receive superficial cervical plexus block with 7 ml of 0.375% Ropivacaine and clavipectoral fascial plane block with 20 ml of 0.375% of Ropivacaine under ultrasound guidance 
          Group II: Patients in this group will receive superficial cervical plexus block with 7 ml of 0.375% Ropivacaine and interscalene brachial plexus block using 20 ml of 0.375% ropivacaine under ultrasound guidance 
          All the patients in the study will be subjected to a thorough pre-anaesthetic evaluation which includes a detailed history taking, complete general physical examination and necessary relevant investigations like complete blood count, blood urea, serum creatinine, chest X-ray, ECG, bleeding time, clotting time. All the patients will be kept nil per oral 8-10 hours for solids and 2 hours for clear fluids. Tablet Alprazolam 0.5 mg and Tablet Pantoprazole 40 mg will be given on the night before surgery. And, at 6 AM on the day of surgery, Injection Pantoprazole 40 mg will be given intravenously. For administration of fluids and drugs, 18G intravenous line will be secured. 
          The patient will be shifted to pre-operative room and multiparameter monitor will be connected and intravenous fluids will be connected and pre-operative heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation, ECG and Diaphragm excursion movement using Ultrasound will be recorded. The superficial cervical plexus block and clavipectoral fascial plane block using 0.375% ropivacaine for Group A patients and superficial cervical plexus block and interscalene brachial plexus block using 0.375% ropivacaine for Group B patients will be given under ultrasound guidance 

ULTRASOUND GUIDED SUPERFICIAL CERVICAL PLEXUS BLOCK
          The patient will be placed in a supine position with the head turned to the opposite side of fracture for adequate exposure of the neck and the upper chest. Under strict aseptic precautions, A high-frequency linear ultrasound probe will be placed at the lateral aspect of neck at the level of cricoid cartilage, Once the sternocleidomastoid muscle is identifed, the probe will be moved posteriorly until the posterior tapering end of the muscle is identified. Then, the superficial cervical plexus (SCP) and investing layer of deep cervical fascia will be visualized and 26 Gauge 1.5 inch needle will be introduced by in-plane technique until its tip reaches near the superficial cervical plexus. After careful negative aspiration to exclude intravascular placement, 7 mL of 0.375% ropivacaine will be deposited.

ULTRASOUND GUIDED CLAVIPECTORAL FASCIAL PLANE BLOCK
          The patient will be placed in a supine position with the head turned to the opposite side of the fracture and the shoulder will be padded with a small pillow. Under strict aseptic precautions, A high frequency linear probe will be placed on either side of fractured site on anterior surface of the clavicle and 26 Gauge 1.5 inch needle will be introduced by in-plane technique from caudal to cephalad direction until its tip reaches between periosteum of clavicle and clavipectoral fascia. After careful negative aspiration to exclude intravascular placement, 10 mL of 0.375% ropivacaine will be deposited on either side of fracture site. 

ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK
          The patient will be placed in a supine position with the head turned to the opposite side of the fracture and the shoulder will be padded with a small pillow. Under strict aseptic precautions, a high frequency linear probe will be placed at the level of cricoid cartilage to visualize the roots of brachial plexus located between the anterior and middle scalene muscles and 26 Gauge 1.5 inch needle will be introduced by in-plane technique to reach near C5 and C6 nerve roots. After careful negative aspiration to exclude intravascular placement, 20 mL of 0.375% ropivacaine will be deposited to achieve its spread between C5 and C6 nerve roots.

          The sensory block, motor block and analgesic duration is assessed using the scales as entered previously in our Part 7 of Trail Registration steps. The diaphragm excursion movement will be assessed using ultrasound during normal tidal volume breaths and deep breaths before giving block and 30th minute and 4th hour after giving the block in both the groups and the incidence of hemi-diaphragmatic paresis or paralysis is assesed  

DIAPHRAGM EXCURSION MOVEMENT:
          Patient will be placed in a supine position. By using low frequency curvilinear probe of ultrasound the diaphragm will be focussed by keeping it longitudinal at the level of anterior axillary line in subcostal region. Then Motion mode (M-Mode) of the diaphragm is used to detect diaphragmatic excursion along a line selected perpendicular to the diaphragm. Two representative images of diaphragmatic excursion will be saved during tidal volume breath and deep breath respectively. The excursion amplitude will be measured as upright perpendicular distance from minimum to maximum point of diaphragmatic excursion. Diaphragm excursion measurement will be done before giving block as preblock value and after giving block at 30th minute and 4th hour. Hemidiaphragmatic paralysis is defined as more than 50% reduction in diaphragmatic excursion compared with preblock value during deep breaths and/or Paradoxical movements of diaphragm after 30 minutes of giving block 
 
Close