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
|
|
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
|
|
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 “fascial
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.
|