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CTRI Number  CTRI/2021/01/030258 [Registered on: 05/01/2021] Trial Registered Prospectively
Last Modified On: 01/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Neural Blocks]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To study the effectiveness of neural blocks in preventing the progression of pain from acute zoster to Post Herpetic Neuralgia 
Scientific Title of Study   A comparative study of the effectiveness of Ultrasonographic guided Erector Spinae Plane Block vs. Para Vertebral Block for Thoracolumbar Zoster associated pain in preventing Post Herpetic Neuralgia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Thanigai Raja P 
Designation  Post Graduate 
Affiliation  JSSH Mysore 
Address  Department of Anesthesiology JSS Medical College And Hospital, MG Road, Agrahara,

Mysore
KARNATAKA
570004
India 
Phone  09500089741  
Fax    
Email  shyam71917@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akkammahadevi P 
Designation  Professor  
Affiliation  JSSH Mysore 
Address  Department of anesthesiology, JSS Medical College And Hospital, MG Road, Agrahara

Mysore
KARNATAKA
570004
India 
Phone  09500089741  
Fax    
Email  drakka_p@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Akkammahadevi P 
Designation  Professor  
Affiliation  JSSH Mysore 
Address  Department of Anesthesiology, JSS Medical College And Hospital, MG Road, Agrahara

Mysore
KARNATAKA
570004
India 
Phone  09500089741  
Fax    
Email  drakka_p@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Pain and palliative care unit, JSS Medical College and Hospital, Mysuru 
 
Primary Sponsor  
Name  Department of Anesthesiology Pain and Palliative care unit JSS Medical College and Hospital Mysuru 
Address  JSS Hospital MG Road Agrahara MYSURU 570004 
Type of Sponsor  Private 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 Thanigai Raja  JSS Medical College and Hospital  OT 15, Pain procedure theatre, Third floor, Operation theatre Division, Department of Anesthesiology JSS Hospital, MG road, Agrahara
Mysore
KARNATAKA 
09500089741

shyam71917@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS MEDICAL COLLEGE AND HOSPITAL MYSURU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B001||Herpesviral vesicular dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil active intervention  Patients will be prescribed rescue analgesics to be taken alongside following the primary treatment as directed by the dermatologist. No active intervention will be attempted. 
Intervention  Thoracic Paravertebral Block or Erector Spinae Plane Block  Neural block either Thoracic Paravertebral Block or Erector Spinae Plane Block will be given to patients based on randomization, while all the study population including control will be prescribed rescue analgesia 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  pain severity according to NRS more than 5 out of 10 
 
ExclusionCriteria 
Details  Patients with history of allergy to local anaesthetic
Immunocompromised patients
Pregnant women
Patients with history of bleeding diathesis
Patients with cardiac and respiratory diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of neural blocks un preventing the progression of pain from acute zoster to post herpetic neuralgia  Pain relief assessment and monitoring progression to Post herpetic neuralgia will be done by repeated follow ups of patients based on reduction in symptoms of pain, QOL and NRS on day 0, 15, 30 and 60 post block procedure. Each visit and follow up will be documented and results tabulated and analyzed at end of 60 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effectiveness of neural blocks i.e, Erector spinae plane block vs Para vertebral block in providing pain relief for acute zoster pain  Pain relief assessment and monitoring progression to Post herpetic neuralgia will be done by repeated follow ups of patients based on reduction in symptoms of pain, QOL and NRS from immediate post procedure period till end of 2 months for each method individually. Each visit and follow up will be documented and results tabulated and analyzed at end of 60 days. 
 
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   N/A 
Date of First Enrollment (India)   01/02/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Following approval From the Institutional Ethics Committee, a double blinded RCT will be carried out on 60 patients presenting with features suggestive of Acute Zoster to pain and palliative care OPD, referred from dermatology OPD in JSS Medical College and Hospital. A thorough medical history from the patients will be obtained, starting from name, age, sex, occupation and then proceeding to their chief complaints, history of presenting illness and risk factors. Pain history regarding onset, duration, site and character of pain along with its aggravating and relieving factors will be documented. Psychological changes due to the pain will be noted. Pain will be assessed based on QOL and NRS. Previous treatments, significant medical history and personal history will be taken as well. General physical examination of the patient, vitals with height and weight will be recorded. Local examination of the skin lesions will be done. Patients assessed eligible for the study will be informed about the procedure. Informed and written consent will be taken, and then be assessed pre anesthetically and with investigations of CBC, Serology, CBG, PT INR etc. While patient is still on their respective treatment protocol as directed by dermatologist, the patients will also be taken for the study as per randomization. They will be divided into 3 groups in accordance with randomization

 

Group 1: Group intervened with ESPB (Erector Spinae Plane Block)

Erector Spinae Plane Block

It is performed by injecting local anesthetic in the plane between the erector spinae muscle and the transverse process at the spinous level corresponding to the affected dermatome. With the transducer fixed over the targeted Transverse Process (TP), needle insertion site is identified and aligned with the long axis of the ultrasound beam and approximately 1–2 cm away from the probe. The insertion site can be cephalad or caudal to the probe, as the TP can be approached from either direction. After sterile preparation, Local Anesthetic skin wheal is placed at the insertion site using a 25–27 g needle. Then needle is inserted (e.g. 23 G Quincke’s spinal needle) through the skin wheal and advanced at a 30–45-degree angle towards the ultrasound beam. The needle is advanced with in-plane ultrasound guidance to the posterior surface of the targeted TP. The operator may feel â€œfascial clicks” corresponding with the fascia of the trapezius, rhomboid (for blocks at T7 and higher), and erector spinae muscles with a final firm end point upon contacting bone. Once the needle tip is in the ESP below the erector spinae muscle, alternating aspiration (to confirm lack of inadvertent vascular puncture) with injection of small aliquots of LA or NS is recommended. Anechoic fluid should be seen separating the erector spinae muscle from the TP, confirming spread within the ESP. Once satisfied with the needle position, LA is gradually injected until a total of 20–40 mL is deposited within the plane.

Post procedure, patients will be prescribed rescue analgesia to be taken only if necessary.

Group 2: Group intervened with TPVB (Thoracic Paravertebral Block)

Thoracic Para Vertebral block 

Paravertebral block (PVB) provides analgesia by injecting local anesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. The best strategy is to start the scanning process 5-10 cm laterally to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identified as more squared structures and deeper to the ribs. Too medial transducer placement will yield image of the laminae, at which point the transducer is moved slightly laterally to image transverse processes. Once the transverse processes are identified, a needle is inserted out-of-plane to contact the transverse process and then, walk off the transverse process 1-1.5 cm deeper to inject local anesthetic. While the position of the needle tip may not be seen with this technique, an injection of the local anesthetic will result in displacement of the parietal pleura. A pragmatic needle insertion 1-1.5 cm past the transverse may be safer than using spread of the injected to displace the pleura as the end-point.

Post procedure, patients will be prescribed rescue analgesia to be taken only if necessary.

Group 3: Group with no interventions (Control)

This group of patients will be counselled about continuing the treatment as instructed by the dermatologist initially and prescribed rescue analgesia to use when needed.

Pain relief assessment and monitoring progression to Post herpetic neuralgia will be done by repeated follow ups of patients based on reduction in symptoms of pain, QOL and NRS on day 0, 15, 30 and 60 post block procedure and the need for rescue analgesia during the study period. Each visit and follow up will be documented and results tabulated and analyzed at end of 60 days.

 

 

 
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