FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/01/030284 [Registered on: 06/01/2021] Trial Registered Prospectively
Last Modified On: 05/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ERECTOR SPINAE BLOCK COMPARING WITH THORACIC EPIDURAL ANAESTHESIA IN OPEN THORACIC SURGERY LIKE THORACOTOMY FOR RELIEVEMENT OF POSTOPERATIVE PAIN 
Scientific Title of Study   COMPARISON OF ERECTOR SPINAE BLOCK VERSUS THORACIC EPIDURAL ANAESTHESIA FOR POSTOPERATIVE PAIN MANAGEMENT IN ADULT PATIENTS UNDERGOING THORACOTOMY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meka Sree Pooja 
Designation  POSTGRADUATE 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL MYSURU 
Address  Junior resident (postgraduate) Department of anaesthesiology JSS medical college and hospital Ramachandra Agrahara Mysuru Karnataka 570004 India

Mysore
KARNATAKA
570004
India 
Phone  9493682891  
Fax    
Email  sreepoojareddy.meka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjula BP 
Designation  Professor 
Affiliation  jss medical college and hospital mysuru 
Address  Dr Manjula BP Professor Department of anaesthesiology JSS medical college and hospital MG road agrahara mysuru Karnataka 570004 India

Mysore
KARNATAKA
570004
India 
Phone  9845501226  
Fax    
Email  bpmanjula5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjula BP 
Designation  Professor 
Affiliation  jss medical college and hospital mysuru 
Address  Dr Manjula BP Professor Department of anaesthesiology JSS medical college and hospital MG road agrahara mysuru Karnataka 570004 India

Mysore
KARNATAKA
570004
India 
Phone  9845501226  
Fax    
Email  bpmanjula5@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL, MYSURU 
 
Primary Sponsor  
Name  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  JSS MEDICAL COLLEGE AND HOSPITAL, MG ROAD, AGRAHARA, MYSURU 
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 MEKA SREE POOJA  JSS MEDICAL COLLEGE AND HOSPITAL  PATIENTS OF CARDIOTHORACIC AND VASCULAR SURGERY DEPARTMENT, THIRD FLOOR, OPERATION THEATRE COMPLEX,MG ROAD,AGRAHARA ,MYSURU,KARNATAKA
Mysore
KARNATAKA 
9493682891

sreepoojareddy.meka@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: J948||Other specified pleural conditions, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae block   Neural blocks like erector spinae block with continuous infusion of local anaesthetic through the catheter will be given 48 hours after extubation to the patients for postoperative pain relief.  
Comparator Agent  NIL  NIL 
Intervention  Thoracic epidural anaesthesia  Through Thoracic epidural, continuous infusion of local anaesthetic through the epidural catheter will be given 48 hours after extubation to the patients for postoperative pain relief 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status class 1 undergoing thoracotomy 
 
ExclusionCriteria 
Details  1. Infection at the site of needle puncture
2. Blood or cerebrospinal fluid tap during the procedure
3. Patients on anticoagulation
4. Patients with bleeding disorders
5. Patients refusal 
 
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 regional neural blocks in providing postoperative pain relief for the patients undergoing thoracotomy  Pain assessment and hemodynamic parameters monitoring post extubation will be done at 0,3,6,12,24,36,48 hours respectively. Based upon VAS pain score patients pain relief will be assessed 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of incentive spirometry
Incidence of nausea, vomiting,pruritis
Duration of ICU stay  
At 0,3,6,12,24,36,48 hours incentive spirometry and occurence of nausea vomiting will be documented 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   10/01/2021 
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="8"
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 Ethical Committee, informed written consent will be taken from 64 patients of  American Society of Anaesthesiologists (ASA) Physical status class I/II undergoing elective thoracotomies. A thorough pre anaesthetic evaluation will be done 24 hours prior to the procedure.  On the day of surgery, a single anesthesiologist performs either erector spinae block or thoracic epidural anaesthesia. A radial arterial line and an 18 G IV cannula will be inserted and the patient is connected to standard monitors such as noninvasive blood pressure, electrocardiography (ECG), and pulse oximetry (SpO2).

Under standardized general anaesthesia protocol, patient will be preoxygenated with 100% oxygen and premedicated with ondansetron 0.1mg/kg, midazolam 0.02mg/kg,
glycopyrrolate 0.01mg/kg and analgesics like fentanyl 2mcg/kg is used and induced with propofol 2mg/kg and muscle relaxants vecuronium 0.1mg/kg. Then patients are going to be
intubated with double lumen endobronchial tubes of respective sizes and connected to mechanical ventilator. Double lumen endobronchial tubes will be kept insitu and extubation is done after 2 hours post-surgery.


After giving general anaesthesia, based upon computer generated randomized sequence, one group of patients will receive thoracic epidural and another group will receive erector
spinae block. Thoracic epidural catheter will be inserted under strict aseptic precautions. An 18 G Tuohy needle is inserted at T6/T7 intervertebral space to identify epidural space using the loss of resistance technique. 20G catheter is threaded 3–4 cm into the epidural space, test dose i.e. 2% lignocaine plus 1:1000 adrenaline 3ml is given after the negative aspiration for blood or cerebrospinal fluid, followed by a continuous infusion of 0.125% sensorcaine plus 2 micrograms per ml fentanyl given at the rate of 5 ml//hour till 48 h postextubation.


Ultrasound guided erector spinae block will be performed under the strict aseptic precautions. A high‐frequency linear ultrasound transducer 12Hz, is placed in a longitudinal
orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. Three muscles trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) are identified superior to the hyperechoic transverse process. Using in‐ plane approach an 18 G Tuohy needle is inserted in caudal–cephalad direction, until the tip
is deep to erector spinae muscle as evidenced by visible hydrodissection below the muscle plane, on injection of 5 ml of normal saline. A 20 G epidural catheter is threaded 3-4 cm in
cephalad direction, after the negative aspiration for blood, followed by continuous infusion of 0.125% sensorcaine plus 2 micrograms per ml fentanyl given at the rate of 5 ml/hour till 48 h post extubation.


Rescue analgesia will be given to patient if visual analog score is >4. First rescue analgesic given to the patient will be paracetamol 20 mg/kg dose. The second rescue analgesic will

be ketorolac 0.5 mg/kg dose diluted in normal saline and administered slowly.

 
Close