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CTRI Number  CTRI/2024/03/064389 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Erector spinae block for pain relief 
Scientific Title of Study   Effects of erector spinae block on the postoperative quality of recovery after Gender Reassignment chest surgeries: a prospective randomized double-blinded 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 Krishna Prasad T 
Designation  Professor 
Affiliation  Shri Sathya Sai Medical College 
Address  Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Centre, Ammapettai, Kancheepuram district, Tamilnadu.

Kancheepuram
TAMIL NADU
603103
India 
Phone  09944579455  
Fax    
Email  drkrishna86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Prasad T 
Designation  Professor 
Affiliation  Shri Sathya Sai Medical College 
Address  Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Centre, Ammapettai, Kanchipuram District, Tamilnadu.

Kancheepuram
TAMIL NADU
603103
India 
Phone  09944579455  
Fax    
Email  drkrishna86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishna Prasad T 
Designation  Professor 
Affiliation  Shri Sathya Sai Medical College 
Address  Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Centre, Ammapettai, Kanchipuram District, Tamilnadu.


TAMIL NADU
603103
India 
Phone  09944579455  
Fax    
Email  drkrishna86@gmail.com  
 
Source of Monetary or Material Support  
Shri sathya sai medical college and research centre 
 
Primary Sponsor  
Name  Krishna prasad T 
Address  professor, shri sathya sai medical college, Srhi balaji vidyapeeth university 
Type of Sponsor  Other [self funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 
krishna prasad T  Shri Sathya Sai Medical College  Ammapettai, Kancheepuram.
Kancheepuram
TAMIL NADU 
09944579455

drkrishna86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  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 
Comparator Agent  Intraoperative blocks   Erector spinae block given bilaterally using 23Guage needle, drug used is ropivacaine 0.5% 10 ml in erector spinae plane block. Total duration 24 hours followed up for the effect of block.  
Intervention  Ropivociane in erector spinae block  to see the efficacy. total duration of 24 hours followed up for the effective block.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both sexes and for transfeminine surgeries 
 
ExclusionCriteria 
Details  not willing for injections 
 
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 
first onset of pain, rescue analgesia  pain assessed at time intervals like 2, 4, 6,8,12 and 24 hours after the block  
 
Secondary Outcome  
Outcome  TimePoints 
complications for the procedure  at intervals in 4, 8, 12 & 24 hours noted. after rescue analgesia 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2/ Phase 3 
Date of First Enrollment (India)   28/03/2024 
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="1"
Months="0"
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  

Regional anesthesia techniques in addition to general anesthesia for postoperative pain have been in practice. Those techniques are performed under ultrasound guidance as part of multimodal analgesia in both intraoperative and postoperative periods. Among the supportive techniques, Erector spinae plane block (ESPB) was first defined for thoracic neuropathic pain treatment in 2016 and was found to provide sufficient postoperative analgesia in thoracic, breast, bariatric, and upper abdominal surgeries concerning the anatomical level applied 1. Although the exact mechanism of ESPB is unknown, it has gained popularity as a result of the growing number of randomized trials that have demonstrated its effectiveness.

 

 

Statistically meaningful increases in postoperative analgesia and reductions in opioid intake, however, can only be clinically significant if they promote a better recovery quality. Whether a relationship exists between ESPB and postoperative recovery quality is still unknown, especially in bilateral breast or chest surgeries.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Postoperative recovery after surgery and anesthesia is a complex and multidimensional process 2. Inadequate recovery quality negatively influences both the patient and the medical team. Although a delayed return to normal activities may produce dissatisfaction with the medical service received prolonged recovery or delayed discharge also significantly impacts the medical team’s resource utilization 3.

 

Therefore, we hypothesized that ESPB could also provide a better quality of recovery in patients who underwent Reassignment Chest surgery, as it allows effective post-operative pain control.

 

The primary outcome of this study was to evaluate the effectiveness of ultrasound-guided ESPB on postoperative quality of recovery after surgery using the 40-item quality of recovery  (QoR-40) questionnaire. Evaluation of the effects of ESPB on postoperative pain, opioid con- consumption, and nausea and vomiting was determined as the further outcome of the study.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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