To study the effectiveness of neural blocks in preventing the progression of pain from acute zoster to Post Herpetic Neuralgia
- Conditions
- Herpesviral vesicular dermatitis,
- Registration Number
- CTRI/2021/01/030258
- Lead Sponsor
- Department of Anesthesiology Pain and Palliative care unit JSS Medical College and Hospital Mysuru
- Brief Summary
Following approval From the Institutional EthicsCommittee, a double blinded RCT will be carried out on 60 patients presentingwith features suggestive of Acute Zoster to pain and palliative care OPD,referred from dermatology OPD in JSS Medical College and Hospital. A thoroughmedical history from the patients will be obtained, starting from name, age,sex, occupation and then proceeding to their chief complaints, history ofpresenting illness and risk factors. Pain history regarding onset, duration, siteand character of pain along with its aggravating and relieving factors will bedocumented. Psychological changes due to the pain will be noted. Pain willbe assessed based on QOL and NRS. Previous treatments, significant medicalhistory and personal history will be taken as well. General physicalexamination of the patient, vitals with height and weight will berecorded. Local examination of the skin lesions will bedone. Patients assessed eligible for the study will be informed about theprocedure. Informed and written consent will be taken, and then be assessed preanesthetically and with investigations of CBC, Serology, CBG, PT INRetc. While patient is still on their respective treatment protocol asdirected by dermatologist, the patients will also be taken for the study as perrandomization. They will be divided into 3 groups in accordance withrandomization
Group 1: Group intervened with ESPB (ErectorSpinae Plane Block)
**Erector Spinae PlaneBlock**
Itis performed by injecting local anesthetic in the plane between the erectorspinae muscle and the transverse process at the spinous level corresponding tothe affected dermatome. With the transducer fixed over the targetedTransverse Process (TP), needle insertion site is identified and alignedwith the long axis of the ultrasound beam and approximately 1–2 cm away fromthe probe. The insertion site can be cephalad or caudal to the probe, as the TPcan be approached from either direction. After sterile preparation, LocalAnesthetic skin wheal is placed at the insertion site using a 25–27 gneedle. Then needle is inserted (e.g. 23 G Quincke’s spinal needle) through theskin wheal and advanced at a 30–45-degree angle towards the ultrasound beam.The needle is advanced with in-plane ultrasound guidance to the posteriorsurface of the targeted TP. The operator may feel “fascialclicks†corresponding with the fascia of the trapezius, rhomboid (forblocks at T7 and higher), and erector spinae muscles with a final firm endpoint upon contacting bone. Once the needle tip is in the ESP below the erectorspinae muscle, alternating aspiration (to confirm lack of inadvertent vascularpuncture) with injection of small aliquots of LA or NS is recommended.Anechoic fluid should be seen separating the erector spinae muscle fromthe TP, confirming spread within the ESP. Once satisfied with the needleposition, LA is gradually injected until a total of 20–40 mL is depositedwithin the plane.
Post procedure, patientswill be prescribed rescue analgesia to be taken only if necessary.
Group 2: Group intervened with TPVB (ThoracicParavertebral Block)
**Thoracic Para Vertebralblock**
Paravertebral block(PVB) provides analgesia by injecting local anesthetic in a space immediatelylateral to where the spinal nerves emerge from the intervertebralforamina. The best strategy is to start the scanning process 5-10 cmlaterally to identify the rounded ribs and parietal pleura underneath. Thetransducer is then moved progressively more medially until transverse processesare identified as more squared structures and deeper to the ribs. Too medialtransducer placement will yield image of the laminae, at which point thetransducer is moved slightly laterally to image transverse processes. Once thetransverse processes are identified, a needle is inserted out-of-plane tocontact the transverse process and then, walk off the transverse process 1-1.5cm deeper to inject local anesthetic. While the position of the needle tip maynot be seen with this technique, an injection of the local anesthetic willresult in displacement of the parietal pleura. A pragmatic needle insertion1-1.5 cm past the transverse may be safer than using spread of the injected todisplace the pleura as the end-point.
Post procedure, patientswill be prescribed rescue analgesia to be taken only if necessary.
Group 3: Group with no interventions (Control)
This group of patients will be counselled aboutcontinuing the treatment as instructed by the dermatologist initially andprescribed rescue analgesia to use when needed.
Pain relief assessment and monitoringprogression to Post herpetic neuralgia will be done by repeated follow ups ofpatients based on reduction in symptoms of pain, QOL and NRS on day 0, 15, 30and 60 post block procedure and the need for rescue analgesia during the studyperiod. Each visit and follow up will be documented and results tabulated andanalyzed at end of 60 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
pain severity according to NRS more than 5 out of 10.
Patients with history of allergy to local anaesthetic Immunocompromised patients Pregnant women Patients with history of bleeding diathesis Patients with cardiac and respiratory diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
JSS Medical College and Hospital
🇮🇳Mysore, KARNATAKA, India
JSS Medical College and Hospital🇮🇳Mysore, KARNATAKA, IndiaDr Thanigai RajaPrincipal investigator09500089741shyam71917@gmail.com