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CTRI Number  CTRI/2024/04/065589 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare specific nerve injection with local site injection in kidney stone surgeries for post operation pain relief. 
Scientific Title of Study   COMPARISON OF UNILATERAL ERECTOR SPINAE PLANE BLOCK AND LOCAL INFILTRATION OF THE INCISION SITE FOR POSTOPERATIVE ANALGESIA IN PERCUTANEOUS NEPHROLITHOTOMY – A RANDOMISED COMPARATIVE STUDY 
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 Neha Gupta 
Designation  Assistant professor 
Affiliation  Dr. B. R. Ambedkar Medical College and Hospital 
Address  DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI

Bangalore
KARNATAKA
560045
India 
Phone  8928351213  
Fax    
Email  drng2105@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Gupta 
Designation  Assistant professor 
Affiliation  Dr. B. R. Ambedkar Medical College and Hospital 
Address  DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI

Bangalore
KARNATAKA
560045
India 
Phone  8928351213  
Fax    
Email  drng2105@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhavyashree V 
Designation  Post graduate 
Affiliation  Dr. B. R. Ambedkar Medical College and Hospital 
Address  DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI

Bangalore
KARNATAKA
560045
India 
Phone  08867777336  
Fax    
Email  venugopal1364@gmail.com  
 
Source of Monetary or Material Support  
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU 
 
Primary Sponsor  
Name  Dr Neha gupta 
Address  DEPATMENT OF ANESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU 
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 Neha gupta  Dr. B. R. Ambedkar Medical College and Hospital  1st FLOOR, OT COMPLEX, DEPARTMENT OF ANESTHESIA, DR B R AMBEDKAR MEDICAL COLLEGE, K G HALLI, BENGALURU - 560045
Bangalore
KARNATAKA 
8928351213

drng2105@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee Dr. B. R. Ambedkar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERECTOR SPINAE PLANE BLOCK  USG guided Erector Spinae Plane Block with 20 mL of 0.25% Bupivacaine + Inj. Dexamethasone 8mg Given once Preoperatively From the time of block to 24 hours after surgery 
Comparator Agent  Local anesthetic infiltration   Local anesthetic infiltration of incision site with 20 mL of 0.25% bupivacaine + Inj. Dexamethasone 8mg Given once Preoperatively From the time of block to 24 hours after surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients posted for Percutaneous Nephrolithotomy Surgeries.
2. Age ≥ 18 years.
3. American Society of Anaesthesiologists (ASA) class I and II patients. 
 
ExclusionCriteria 
Details  1.Patients with history of known allergy to local anesthetic agent
2. Patients who have contraindications to peripheral nerve blocks
3. Infection at the site of injection
4. Body mass index more than 35 kg/m2
5. Drug abuse, sepsis, bacteremia physiological or other emotional problems. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the duration of postoperative analgesia of USG guided ESPB compared
with surgical site local infiltration in patients undergoing PCNL 
24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the total need of rescue analgesia in first 24 hours.
2. Incidence of postoperative nausea and vomiting 
24 hours after surgery 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   01/05/2024 
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)   Not Applicable 
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   Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical technique and a gold standard technique for the removal of large (>20 mm) renal and upper ureteric calculi. However, it may be associated with substantial postoperative pain due to stretching of the renal capsule the parenchymal tract and from the incision of the skin, subcutaneous tissue, muscle layer, and the presence of nephrostomy tube. Several modalities of analgesia have been tried to decrease post operative pain. The analgesic modalities that have been tried include: several systemic analgesics [opioids, non-steroidal anti-inflammatory drugs (NSAIDs)], paracetamol, and regional techniques (subcutaneous infiltration, peritubal infiltration, intercostal nerve block (ICNB), paravertebral block (PVB), epidural analgesia] that have been tried for providing postoperative analgesia. While NSAIDs can have potential systemic side
effects in these patients with possible kidney injury, other regional techniques like epidural and paravertebral blocks can be pretty invasive. Patients posted for PCNL surgery often have suboptimal renal function and non-steroidal anti-inflammatory drugs (NSAID) are potentially nephrotoxic. Therefore novel regional anesthetic techniques that would provide optimal pain control without significant adverse effects need to be explored.
Erector Spinae Plane Block (ESPB) is a novel analgesic technique which was first described in 2016 for thoracic neuropathic pain. It has subsequently found efficacious for acute pain control after surgeries like Mastectomies, Percutaneous Nephrolithotomy, Lumbar spine surgeries, Laparoscopic Cholecystectomy. ESPB involves injection of the local anaesthetic into the plane between the erector spinae muscle sheath and the transverse process of the vertebra. When injected, the injectate spreads cranio-caudally
resulting in the blockage of multiple vertebral levels. ESPB affects both the ventral and dorsal rami, leading to blockage of both visceral and somatic pain.
Local anesthetic infiltration of incision site is another novel modality of pain relief in PCNL surgery (skin, subcutaneous tissue, renal capsule, and parenchymal tract) is done with local anesthetic drugs. This can produce significant reduction of pain as assessed by visual analog scale (VAS) score with less demand for rescue analgesia.
This study was designed to compare the efficacy of USG guided ESPB with local infiltration at the incision site in providing postoperative analgesia following PCNL.
 
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