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CTRI Number  CTRI/2025/12/099097 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two types of nerve blocks in collar bone surgeries 
Scientific Title of Study   A randomised comparative study to assess the efficacy of Interscalene brachial plexus block with superficial cervical plexus block versus Clavipectoral fascial plane block with superficial cervical plexus block in clavicle surgeries under ultrasound guidance. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sridevi P 
Designation  Assistant Professor 
Affiliation  Aarupadai Veedu Medical College and Hospital, Pondicherry 
Address  Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital, Pondicherry-607402, India

Pondicherry
PONDICHERRY
607402
India 
Phone  8072586724  
Fax    
Email  dr.sripanneer30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sridevi P 
Designation  Assistant Professor 
Affiliation  Aarupadai Veedu Medical College and Hospital, Pondicherry 
Address  Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital, Pondicherry-607402, India

Pondicherry
PONDICHERRY
607402
India 
Phone  8072586724  
Fax    
Email  dr.sripanneer30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sridevi P 
Designation  Assistant Professor 
Affiliation  Aarupadai Veedu Medical College and Hospital, Pondicherry 
Address  Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital, Pondicherry-607402, India

Pondicherry
PONDICHERRY
607402
India 
Phone  8072586724  
Fax    
Email  dr.sripanneer30@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, First floor A block, Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Pondicherry - 607403, India. 
 
Primary Sponsor  
Name  Sridevi P 
Address  Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Pondicherry - 607402, India. 
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 Sridevi P  Aarupadai Veedu Medical College and Hospital, Pondicherry  Department of Anaesthesiology, First floor, A block, Aarupadai Veedu Medical College and Hospital, Pondicherry.
Pondicherry
PONDICHERRY 		 8072586724

dr.sripanneer30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AVMC Institutional Human Ethical Committee  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 
Intervention  Clavipectoral fascial plane block with Superficial cervical plexus block  A single injection of 22ml of 0.5% Levobupivacaine, 2% Lignoadrenaline and 8mg of Dexamethasone will be given in the space between the periosteum of clavicle and the clavipectoral fascia before the start of surgery. 
Comparator Agent  Interscalene brachial plexus block with Superficial cervical plexus block  A single injection of 22ml of 0.5% Levobupivacaine, 2% Lignoadrenaline and 8mg of Dexamethasone will be given in the neck region in the space between anterior and middle scalene muscles before the start of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2
BMI less than 30 
 
ExclusionCriteria 
Details  Patients unwilling to enroll for study.
Known allergy to local anaesthetics.
Infection at the site of block placement.
Severe cardio-cerebrovascular diseases.
Respiratory insufficiency.
Bleeding disorders.
Chronic opioids usage.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of ultrasound guided Clavipectoral fascial plane block with Superficial cervical plexus block versus ultrasound guided Interscalene brachial plexus block with Superficial cervical plexus block in patients undergoing clavicle fracture surgeries measured using Visual Analogue Scale.  Postoperatively at 1,2,4,6,8,10, 12,16,20 and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the ease of technique by means of block performance time.  From needle insertion till the needle is taken out after final injection 
To assess incidence of complications.  From needle insertion till 24 hours postoperatively
 
To evaluate patient satisfaction score using five-point Likert scale  End of surgery till 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   26/12/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  If requested through email data will be shared - dr.sripanneer30@gmail.com

  6. For how long will this data be available start date provided 26-06-2026 and end date provided 26-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Clavicle fractures are common injuries requiring surgical intervention. Providing effective regional anaesthesia for clavicle surgeries is essential to ensure optimal analgesia with facilitated intraoperative conditions and enhanced postoperative recovery than general anaesthesia. The novel approach - Clavipectoral fascial plane block minimizes or spares the phrenic nerve and motor fibres involvement while providing adequate surgical anesthesia than Interscalene brachial plexus block. With increasing use of ultrasound guidance both these techniques can now be performed with enhanced precision and safety. By evaluating the benefits and limitations of each approach this study aims to provide evidence based insights into optimizing regional anaesthesia strategies for clavicular procedures and hypothesizes that Clavipectoral fascial plane block with superficial cervical plexus block is superior to Interscalene block with superficial cervical plexus block in terms of duration of analgesia along with ease of technique and lesser complications.
   
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