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CTRI Number  CTRI/2024/08/071781 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Pain relief in thoracoscopic procedures without loss of consciousness  
Scientific Title of Study   Efficacy of combined Thoracic Segmental Spinal Anaesthesia and Erector Spinae Plane Block in patients undergoing thoracoscopic procedures a prospective observational 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 Karthik GS 
Designation  Professor 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  Department of Anaesthesia, 2nd floor, Rajarajeswari Medical College and Hospital, Kambipura, Mysore road, Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9538220515  
Fax    
Email  drgskarthik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shwetha AH 
Designation  post graduate 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  Department of Anaesthesia, 2nd floor, Rajarajeswari Medical College and Hospital, Kambipura, Mysore Road

Bangalore
KARNATAKA
560074
India 
Phone  09449795180  
Fax    
Email  ahshwetha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shwetha AH 
Designation  post graduate 
Affiliation  Rajarajeswari Medical College and Hospital 
Address  Department of Anaesthesia, 2nd floor, Rajarajeswari Medical College and Hospital, Kambipura, Mysore Road

Bangalore
KARNATAKA
560074
India 
Phone  09449795180  
Fax    
Email  ahshwetha@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore-560074, Karnataka 
 
Primary Sponsor  
Name  Rajarajeswari Medical College and Hospital 
Address  Department of Anaesthesia, 2nd floor, Rajarajeswari Medical College and Hospital, Kambipura, Mysore road, Bangalore 560074, Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 Shwetha A H  Rajarajeswari Medical College and Hospital  Department of Anaesthesia, 2nd floor, Rajarajeswari Medical College and Hospital, Kambipura, Mysore road, Bangalore
Bangalore
KARNATAKA 		 9449795180

ahshwetha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari Medical College & Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J869||Pyothorax without fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Thoracic segmental spinal plus erector spinae plane block  Patients will receive thoracic segmental spinal at T5-T6 level with 1 ml of 0.5% isobaric levobupivacaine + 25 mcg fentanyl . Once level of block is adequate, erector spinae block under ultrasound guidance using linear probe with 15 ml of 0.25% Levobupivacaine at T7 level. Patients will be assessed for 24 hours. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA 1, 2 and 3 patients of either sex
2. Patients aged between 20 to 60 years
3. Patients undergoing thoracoscopic procedure
 
 
ExclusionCriteria 
Details  1. Patient’s refusal
2. ASA 4 patients
3. Patients with known hypersensitivity to local anaesthetics
4. Patients with bleeding disorder
5. Patients with epilepsy
6. Mentally unstable patients
7. Patients with neurological deficits
8. Infection at local site 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate the analgesic efficacy of combined thoracic segmental spinal anaesthesia and erector spinae plane block in patients undergoing thoracoscopic procedures  1,3,5,10,15,30,45,60,90 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Sensory blockade level
Changes in hemodynamic parameters intra-operatively
SPO2
Heart rate
Blood pressure
Patient recovery and satisfaction
Post-operative complications if any  		 Intraoperatively, 1,2,4,6,8,12,24 hours 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   Phase 4 
Date of First Enrollment (India)   12/08/2024 
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 Yet Recruiting 
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   A prospective, analytical observational study will be conducted in 25 patients at Rajarajeswari Medical College and Hospital. Thoracoscopic procedures are generally done under general anesthesia but carries risk of ventilator dependency in patients with severe respiratory diseases. This study avoids general anesthesia and determines the efficacy of combined Thoracic Segmental Spinal Anaesthesia and Erector Spinae Plane Block in such patients. 
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