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CTRI Number  CTRI/2025/07/091305 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 20/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing efficacy of two combination blocks in patients undergoing surgery for fixation of fracture clavicle  
Scientific Title of Study   A COMPARATIVE EFFICACY OF ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK COMBINED WITH SUPERFICIAL CERVICAL PLEXUS BLOCK VERSUS CLA VIPECTORAL FASCIA PLANE BLOCK COMBINED SUPERFICIAL CERVICAL FLEXUS BLOCK IN PATIENTS UNDERGOING FIXATION OF FRACTURE CLAVICLE: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushma J Ayli 
Designation  Postgraduation 
Affiliation  Ballari Medical college and research centre ,Ballari 
Address  Sushma J Ayli Department of Anaesthesia Cantonment, Ballari Medical college and Research centre,Ballari.

Bellary
KARNATAKA
583101
India 
Phone  9108717609  
Fax    
Email  aylisushma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrBala Subramanya H 
Designation  Professor 
Affiliation  Ballari Medical college and research centre ,Ballari 
Address  Department of Anaesthesia Cantonment, Ballari Medical college and Research centre,Ballari

Bellary
KARNATAKA
583101
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrBala Subramanya H 
Designation  Professor 
Affiliation  Ballari Medical college and research centre ,Ballari 
Address  Department of Anaesthesia Cantonment, Ballari Medical college and Research centre,Ballari

Bellary
KARNATAKA
583101
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Source of Monetary or Material Support  
Trauma care centre,BMCRC Ballari 
 
Primary Sponsor  
Name  Ballari Medical College and Research Centre,Ballari 
Address  Cantonment Ballari Karntaka State Pin 583104 
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 Sushma J Ayli  Ballari Medical College and Research Centre  Department of Anaesthesiology, BMCRC, Ballari
Bellary
KARNATAKA 
9108717609

aylisushma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,BMCRC  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  Group A: Patients will receive interscalene brachia! plexus block (ISB) combined with superficial cervical plexus block (SCPB) Group B: Patients will receive clavipectoral facia plane block and superficial cervical plexus block   Study drug is prepared by adding 22.5 mL of 0.5% bupivacaine with 7.5 mL of sterile water to obtain a concentration of0.375% ofbupivacaine. Ultrasound guided block(USG) will be performed as per the group by an anaesthetist having experience of performing at least 50 ultrasoung guided blocks.Sono site® ultrasound machine with 8-13 MHZ linear probe will be used to perform the blocks. . The randomisation is done using the randomization number obtained from the website www.randomization.org. Group allocation concealment is done by sequentially numbered sealed opaque sealed envelope (SNOSE) technique . Patient will be withdrawn from the study in case of failure or patchy block, and general anaesthesia will be given for the completion of the case. The intra-operative and post-operative assessments of patients and data recording will be carried out by another Anaesthesiologist who is blinded to the technique of USG guided nerve block.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Any patient with unilateral fracture clavicle undergoing surgery for elective fixation.
2 Patient belonging to ASA 1-II physical status
3 Patients of either sex in the age group of 18 -65 years  
 
ExclusionCriteria 
Details  1 Patient refusal
2 Patient with allergy to local anaesthetic agents
3 Patient with pre-ex.isting injury to brachial plexus
4 Patient with coagulopathies or bleeding disorder
5 Patient with infection al the site of block
• Patients on any steroids or on long term analgesics
• Patient with severe systemic disorder
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia in two groups  Immediate post op, 30 min,1 hr , 2 hr ,3 hr 
 
Secondary Outcome  
Outcome  TimePoints 
-Onset of sensory blockade over clavicle
-Upper limb weakness
-Total requirement of analgesics in first 24hrs
-Assessment of pain at various intervals by NRS pain score.
-Diaphragmatic movement
-Complications if any

 
Intra operative and post operative 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   01/08/2025 
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  
Title: A comparative efficacy of ultrasound guided interscalene brachia! plexus block 
combined with superficial cervical plexus block versus clavipectoral fascia plane block  combined superficial cervical flexus block in patients undergoing fixation of fracture  clavicle: A randomized controlled trial 
Need for Study / Introduction 
Clavicular fracture is the most common injury in the shoulder, particularly in young men. It mainly occurs due to sports or road traffic accidents, especially in the middle of the clavicle. 
Better functional results can be obtained by surgical fixation of the fracture. 
Exact innervation of clavicle is debatable 1• The supraclavicular nerve of the superficial cervical  plexus is responsible for innervation of the bone and skin above the clavicle, while the brachial plexus innervates the deep muscle of the clavicle. 
Regional anaesthesia carri es several advantages over general anaesthesia. lnterscalene brachial plexus block in combination with superficial cervical plexus block is commonly used anaesthetic technique for the surgical fixation of fracture clavicle. General anaesthesia is the other option but carries inherent risk of polypharmacy,airway trauma and neuroendocrine stress response to intubation.

Clavipectoral fascia! plane block(CPB) is a new regional nerve block proposed by Valdes in 2017 where in local anaesthetic agents are injected into clavipectoral fascia plane which can be used for anaesthesia and postoperative analgesia in patients undergoing surgery for fracture clavicle. 
It provides effective pain control for procedures involving the midshaft and lateral clavicle. 
This typically avoids phrenic nerve blockade, thus preserving diaphragmatic function • It also minimizes unnecessary numbness or motor block in adjacent regions. It is easily visualized with ultrasound, which enhances precision and safety of this block. This block can be performed in combination with other regional techniques (e.g., superficial cervical plexus block) for broader cove rage. There are very few studies comparing the efficacy of clavipectoral block with the commonly used inter scalene brachial plexus block in combination with superficial cervical plexus for 
fixation of fracture clavicle. Hence this study is conducted to explore the comparative efficacy of this block. 
Review of Literature 
1. Guangmin Xu, et al. (2017)3 in a randomized controlled trial compared US guided superficial cervical plexus block with clavipectoral fascia! plane block or interscalene brachial plexus block in 50 patients who underwent elective internal fixation of fracture clavicle. The effects of the block measured at 30 min of both regional anaesthesia were very satisfactory. Compared with ultrasound-guided SCPB and ISBP, SCPB combined with CPB for clavicular operation has longer postoperative analgesia, better preserves the motor function of the upper limbs and avoids the incidence of diaphragmatic paralysis. Therefore, this technique is suitable for application in clinical practice. 
2. Olofsson M., ct al (2020)4 in a matched case- controlled study done on 50 consecutive patients who underwent surgical fixation of clavicle. All patients received lnterscalene brachial plexus block for surgical repair of clavicle fracture .The study concluded that there is significant lower consumption of iv morphine in the whole cohort.
3_ Kukrc.ia P, ct al. (2020t in a case series on ultrasound-guided Clavipectoral Fascia! Plane Block for Surgery involving the Clavicle in 3 patients found that the CPB is another effective alternate anaesthesia technique while avoiding undesirable side effects of more proximal techniques such as motor blockade or phrenic nerve paralysis. Moreover, it does not carry any risk of pneumothorax. The technique is easy to perform and has an advanced safety profile, especially for patients with respiratory disease. Compared with other brachial plexus blocks which prevent pain transmission more proximally, CPB offers more distal blockade and superficially. This case series adds up to evidence supporting the utility of CPB. 
4. Faramarz Mosaffa, et al (2023)6 in a randomized double-blinded, non-inferiority clinical trial on 120 patients compared interscalene block (ISB) with or without superficial cervical plexus block (SCPB) for anaesthesia in clavicle surgery. The primary outcome was defined as the conversion to GA. Various factors were recorded, including surgery duration, nerve block initiation, analgesics required in the post anaesthesia care unit (PACU), and sedation during surgery. Efficacy of ISB is the same whether or not it is combined with a SCPB. lnterscalene block is an alternative regional anaesthesia approach for clavicle fractures. Thus, ISB alone is as efficient as when used in combination with SCPB. 

 
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