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CTRI Number  CTRI/2025/11/096793 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find out which works better for intraoperative and postoperative pain relief in clavicle fracture surgery using superficial cervical plexus block combined with interscalene block vs clavipectoral block under ultrasound guidance .  
Scientific Title of Study   Ultrasound guided superficial cervical plexus block with interscalene block vs clavipectoral block in clavicle 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 SASIREKHA S 
Designation  FIRST YEAR DNB RESIDENT  
Affiliation  Indira Gandhi Government General Hospital and Postgraduate Institute 
Address  Department of Anaesthesiology, Indira Gandhi Government General Hospital and PG Institute, No.1,Rue Victor Simonal Street, Pondicherry.
NIL
Pondicherry
PONDICHERRY
605001
India 
Phone  9489630490  
Fax  -  
Email  sasirekhasomu106@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhan 
Designation  Head of the department  
Affiliation  Indira Gandhi Government General Hospital and Postgraduate Institute 
Address  Department of Anaesthesiology, Indira Gandhi Government General Hospital and Postgraduate Institute, No:1,Rue Victor Simonal Street, Pondicherry
NIL
Pondicherry
PONDICHERRY
605001
India 
Phone  7373933999  
Fax  -  
Email  drmadhan76@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhan 
Designation  Head of the department  
Affiliation  Indira Gandhi Government General Hospital and Postgraduate Institute 
Address  Department of Anaesthesiology, Indira Gandhi Government General Hospital and Postgraduate Institute, No:1,Rue Victor Simonal Street, Pondicherry
NIL
Pondicherry
PONDICHERRY
605001
India 
Phone  7373933999  
Fax  -  
Email  drmadhan76@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sasirekha S 
Address  Indira Gandhi Government General Hospital and Postgraduate Institute,No:1, Rue Victor Simonal Street, Pondicherry 605001 
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 SASIREKHA S  INDIRA GANDHI GOVERNMENT GENERAL HOSPITAL AND POSTGRADUATE INSTITUTE   Department of Anaesthesiology, NO:1, Rue Victor Simonal Street, Pondicherrry, 605001
Pondicherry
PONDICHERRY 		 9489630490
-
sasirekhasomu106@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
General Hospital Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Superficial cervical plexus block with clavipectoral block  The superficial cervical plexus block combined with clavipectoral block given under ultrasound guidance  
Intervention  Superficial cervical plexus block with interscalene block  The superficial cervical plexus block combined with interscalene block given under ultrasound guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient willing to participate and who give informed consent
2.American Society Of Anaesthesiology class I & II
3.Patient planned for clavicle surgery 
 
ExclusionCriteria 
Details  American Society Of Anaesthesiology class III and more
Pregnant and lactating mother
Patient preexisting with pulmonary and neurological disorders
Bleeding disorders
Local site infection
Allergy to local anaesthetic agent  
 
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 
To evaluate the effect of the block in terms of onset and duration of sensory blockade, Onset and duration of motor blockade and watch for any complications  The sensory and motor blockade will be assessed intraoperatively and postoperatively for 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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 2/ Phase 3 
Date of First Enrollment (India)   25/11/2025 
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 Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    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 - Proposals should be directed to [sasirekhasomu106@gmail.com].

  6. For how long will this data be available start date provided 25-11-2030 and end date provided 25-11-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The clavicle fractures are treated by surgical management which were done under general anaesthesia . The general anaesthesia is associated is postoperative complications like sore throat, bronchospasm which can be avoided by regional anaesthesia. The study is compare the efficacy of the ultrasound guided superficial cervical plexuses blocked combined with interscalene brachial plexuses block vs clavipectoral fascial plane block thereby reducing the complications associated with general anaesthsia  and good postoperative analgesia .   
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