FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063978 [Registered on: 12/03/2024] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two types of anaesthesia nerve blocks for postoperative pain management in patients undergoing robot assisted radical prostate operation 
Scientific Title of Study   Erector spinae plane block and transverse abdominis plane block for postoperative analgesia in robotic assisted radical prostatectomy- A single centre, prospective, double blind, randomised controlled trial 
Trial Acronym  PRO-TAPES 
Secondary IDs if Any  
Secondary ID  Identifier 
N.A.  NIL 
PRO-TAPES  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srimanta Kumar Halder 
Designation  Consultant 
Affiliation  Tata Medical Center 
Address  Department of Onco-anaesthesia, 14 MAR (E-W), New Town, Rajarhat , Kolkata

North Twentyfour Parganas
WEST BENGAL
700160
India 
Phone  9438910048  
Fax    
Email  haldarkeshab2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Srimanta Kumar Halder 
Designation  Consultant 
Affiliation  Tata Medical Center 
Address  Department of Onco-anaesthesia, 14 MAR (E-W), New Town, Rajarhat , Kolkata

North Twentyfour Parganas
WEST BENGAL
700160
India 
Phone  9438910048  
Fax    
Email  haldarkeshab2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Srimanta Kumar Halder 
Designation  Consultant 
Affiliation  Tata Medical Center 
Address  Department of Onco-anaesthesia, 14 MAR (E-W), New Town, Rajarhat , Kolkata

North Twentyfour Parganas
WEST BENGAL
700160
India 
Phone  9438910048  
Fax    
Email  haldarkeshab2@gmail.com  
 
Source of Monetary or Material Support  
Tata Medical Center, Kolkata, India 
 
Primary Sponsor  
Name  Tata Medical Center 
Address  14 MAR (E-W), New Town, Rajarhat , Kolkata-700160, West Bengal, India 
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 
Srimanta Kumar Halder  Tata Medical Center  Department of Onco-anaesthesia, 14 MAR (E-W), New Town, Rajarhat, Kolkata
North Twentyfour Parganas
WEST BENGAL 		 9438910048

haldarkeshab2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Medical Center- Institutional Review Board  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 (ESPB)   Patients will be positioned in a lateral decubitus position. At T11 probe is placed transverse to identify the midline and moved laterally to identify TP. The erector spinae muscle and transverse process will be observed by sliding the transducer to the lateral aspect from the midline by approximately 3–4 cm. The 20G, 100mm needle will be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction. 20ml of ropivacaine 0.2% will be injected. Same procedure will be repeated on the contralateral ESPB. This will be an one time procedure. 
Comparator Agent  Transversus abdominis plane block (TAPB)  For TAPB group, the block will be performed in supine position. An ultrasound probe will be placed on the abdominal wall with a transverse orientation along the mid-axillary line, halfway between the costal margin and the anterior superior iliac spine. A 20G, 100-mm needle will be inserted into the skin just medial to the ultrasound probe. The needle will be advanced until the tip rested within the plane between internal oblique and transversus abdominis muscles. 20 mL of ropivacaine 0.2% will be injected. The same process will then be undertaken on the contralateral side of the abdomen. This will be an one time procedure. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. Patients who will undergo elective robot assisted radical prostatectomy
2. American Society of Anaesthesiology Physical Score (ASA-PS) score of I - III
3. Age- above 18 years 
 
ExclusionCriteria 
Details  1. Patients receiving systemic opioids for chronic pain
2. Local site infection
3. Patient sent on mechanical ventilation to ICU postoperatively
4. Failure to give block due to technical issues 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intravenous morphine consumption in mg  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
● Postoperative rescue fentanyl requirements in mcg in the first 24 hours
● Numeric Rating Scale (NRS) at rest on arrival at the ICU (T0); 3 hours (T1); 6 hours (T2); 12 hours (T3); 24 hours(T4)
● Modified Ramsay Sedation Score on arrival at the ICU (T0); 3 hours (T1); 6 hours (T2); 12 hours (T3); 24 hours( T4)
● NRS on first ambulation
● NRS on coughing
● Time to enteric resumption
● Time to ambulation
● Time to flatus pass
● Postoperative nausea and vomiting at the above-mentioned time points
● Patient satisfaction score
● Length of hospital stay 		 First 24 hours 
 
Target Sample Size   Total Sample Size="29"
Sample Size from India="29" 
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)   15/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
With the rise in the number of robotic prostatectomy cases, the need for adequate pain relief following the surgery has become important. Due to the adverse effects related to opioids, use of opioid sparing multimodal analgesia techniques including myofascial plane blocks can be used for adequate pain relief.
In this study we plan to divide the patients into two groups and use erector spinae plane and transversus abdominis plane block following surgery with local anaesthetics under ultrasound guidance. Patients would be provided with PCA pumps delivering morphine when required in the postoperative period and bolus fentanyl for breakthrough pain.
Categorical data will be expressed as frequencies (percentage) and analysed using the Chi-square or Fisher exact test. Continuous variables will be presented as means +/-SD or median with interquartile range and will be compared with independent t test or Mann-Whitney U test. Statistical analysis will be performed using the Statistical Package for the Social Sciences software. Sample size calculation will be performed with the G* power 3 software.
The patients will be explained about the risks and benefits of the two methods of analgesia during pre-anaesthesia check up and written informed consent will be taken. They will also be informed about Numeric Rating Scale (NRS) and trained how to operate the PCA pump. All patients will be prepared according to ERAS protocol. In both the groups, general anaesthesia will be administered and routine care will be provided.
For ESPB group, patients will be positioned in a lateral decubitus position. Under ultrasound guidance following hydro-dissection 20 ml of 0.2% ropivacaine will be administered on both sides. In the TAPB group, the block will be performed in supine position. 20 ml of 0.2% ropivacaine will be given under ultrasound guidance following hydro-dissection on both sides.
Outcome measures:-
Primary outcome:
  • 24 hours intravenous morphine consumption in mg
Secondary outcome:
  • Postoperative rescue fentanyl requirements in mcg in the first 24 hours
  • NRS at rest on arrival at the ICU (T0); 3 hours (T1); 6 hours (T2); 12 hours (T3); 24 hours (T4)
  • Modified Ramsay Sedation score on arrival at the ICU (T0); 3 hours (T1); 6 hours (T2); 12 hours (T3); 24 hours (T4)
  • NRS on first ambulation
  • NRS on coughing
  • Time to enteric resumption
  • Time to ambulation
  • Time to flatus pass
  • Postoperative nausea and vomiting at the above mentioned time points
  • Patient satisfaction score
  • Length of hospital stay

 
Close