FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100685 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Safety of Low dose Local Anesthetics for proxysmal synthetic Dysfunction 
Scientific Title of Study   Safety of low dose local anesthetics for Paroxysmal Sympathetic Dysfunction 
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 Ravi Sankaran 
Designation  Professor and Head 
Affiliation  Amrita Hospitals 
Address  Amrita Hospitals,Department of PMR, E block ground floor, Room No 11

Ernakulam
KERALA
682041
India 
Phone  02854848123  
Fax    
Email  ravisankaran@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Sankaran 
Designation  Professor and Head 
Affiliation  Amrita Hospitals 
Address  Amrita Hospitals Department of PMR E Block, Room 11, Kochi

Ernakulam
KERALA
682041
India 
Phone  02854848123  
Fax    
Email  ravisankaran@aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Sankaran 
Designation  Professor and Head 
Affiliation  Amrita Hospitals 
Address  Amrita Hospitals DEpartment of PMR E Block Room 11
Amrita Hospitals- Kochi
Ernakulam
KERALA
682041
India 
Phone  02854848123  
Fax    
Email  ravisankaran@aims.amrita.edu  
 
Source of Monetary or Material Support  
Amrita Institute of Medical sciencesand research centre, AiMS, Ponekkara, Kochi, Eranakulam,Kerala, India, Pin: 682041 
 
Primary Sponsor  
Name  Amrita Institute of Medical sciences 
Address  Amrita Institute of Medical sciencesand research centre, AIMS, Ponekkara, Kochi, Eranakulam,Kerala, India, Pin: 682041 
Type of Sponsor  Research institution and hospital 
 
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 Ravi Sankaran  Amrita Hospitals- Kochi  Department of PMR E block, Ground floor, Roon no 11 Amrita Hospitals, Kochi
Ernakulam
KERALA 		 02854848123

ravisankaran@aims.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ECASM-AIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G908||Other disorders of autonomic nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator  Not Applicable 
Intervention  Low dose local anaesthetic block  Six injections will be given once a week. The intervention will be delivered to the vagus nerve and stellate ganglion depending on the clinical presentation. The same cycle will be repeated weekly. Duration of treatment is four weeks. Heart rate and blood pressure will be monitored during the procedure. Structures for injection will be localized using ultrasound guidance and anatomical landmarks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion criteria were Hypoxic Ischemic Encephalopathy within the first three months, not on a ventilator or inotropic support, CRS-R 3 to 8, radiological grading stage 38, storming by PSH criteria 9, PSH not resolving a week from coming out of ICU, DLT score of 5+, propranolol at maximum tolerate doses, minimal acute phase reactant elevation and culture negative. 
 
ExclusionCriteria 
Details  Exclusion criteria were requiring celiac ganglion block,sepsis concomitant UTI, upper GI bleed confirmed by occult blood testing, and comorbid Psychiatric Orthopedic, or Neurological conditions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduced PSH score  0,1,2,3,4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
estimate the change in PSH and DTC and evaluate the toxicities and adverse events associated with delivering multiple doses of low dose local anesthetic.   0,1,2,3,4 weeks 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   20/01/2026 
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)   Open to Recruitment 
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   Hypoxic–ischemic encephalopathy (HIE) occurs after global cerebral ischemia and can lead to outcomes ranging from persistent vegetative state to complete recovery. The management of HIE is multidisciplinary and offered to medically stable individuals. Paroxysmal Sympathetic Hyperactivity (PSH), also called Paroxysmal Autonomic Instability with Dystonia (PAID), occurs in 7–33% of HIE cases within the first three months. PSH presents with agitation, sweating, fever, high blood pressure, fast heart rate, rapid breathing, and extensor posturing. Standard drugs used include morphine, bromocriptine, propranolol, clonidine, lorazepam, and dantrolene, yet outcomes often remain poor with prolonged care and minimal functional gains. Neural therapy, which uses low-dose short-acting local anesthetics at autonomic structures, has shown promise in reducing autonomic dysfunction through blocks of the stellate ganglion or vagus nerve. The primary aim of this pilot study was to test the feasibility of such low-dose blocks in PSH, with secondary aims of assessing PSH score changes, DLT score, and treatment-related adverse events. The study was conducted in a tertiary rehabilitation center with ethics approval (ECASM-AIMS-2025-165, CTRI registered), and informed consent was obtained from families. Eligible patients had HIE within three months, were off ventilator and inotropes, had CRS-R scores between 3 and 8, radiological stage 3 injury, unresolved PSH for one week post-ICU, a DLT score of 5+, were on maximum tolerated propranolol, and had no active infection or comorbidities. Patients received six injections weekly for four weeks, with anesthetic blocks of the stellate and vagus nerves under ultrasound guidance, and outcomes were tracked using validated PSH and DLT scoring systems. 
Close