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CTRI Number  CTRI/2022/08/044943 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 11/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the efficacy of pain reduction between 2 different injections ( costotransverse foramen block versus thoracic paravertebral block ) over the back in patients undergoing breast surgery. 
Scientific Title of Study   Analgesic efficacy of ultrasound guided Costotransverse foramen block versus Thoracic paravertebral block in patients undergoing breast surgery under general anaesthesia:A Prospective Double Blind Randomised Controlled Non-Inferiority Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Virender Kumar Mohan 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room no 5008(A), 5th floor, Academic block, AIIMS, Ansari Nagar

New Delhi
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Virender Kumar Mohan 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room no 5008(A), 5th floor, Academic block, AIIMS, Ansari Nagar

New Delhi
DELHI
110029
India 
Phone  9891557705  
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr VigneshV 
Designation  Junior Resident (Post Grad - Acad) 
Affiliation  AIIMS New Delhi 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, AIIMS, Ansari Nagar

New Delhi
DELHI
110029
India 
Phone  08778339932  
Fax    
Email  vvignesh0210@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar,New Delhi 110029 
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 Virender Kumar Mohan  AIIMS HOSPITAL  Department of Anesthesiology , Pain medicine and Critical Care, Ot complex , AIIMS , Ansari nagar , South Delhi
New Delhi
DELHI 
9891557705

dr_vkmohan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute 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 
Intervention  Costo transverse foramen block   the regional blocks will be performed by the investigator before induction and the patient will not know about the type of intervention and an anaesthesiologist blinded to the study groups will be responsible for postoperative follow up. Hence, it will be conducted as a double blind study. Both the blocks will be performed in pre anesthesia room with facilities of monitoring and oxygen. Intravenous access will be secured. Patients will be in sitting position with neck slightly flexed and back arched towards the operator. Same position will be employed for the conduct of regional block. The block will be performed at T4 level using 15ml of 0.375% Ropivacaine. 
Comparator Agent  Nil  Nil 
Intervention  Thoracic paravertebral block  The regional blocks will be performed by the investigator before induction and the patient will not know about the type of intervention and an anaesthesiologist blinded to the study groups will be responsible for postoperative follow up. Hence, it will be conducted as a double blind study. Both the blocks will be performed in pre anesthesia room with facilities of monitoring and oxygen. Intravenous access will be secured. Patients will be in sitting position with neck slightly flexed and back arched towards the operator. Same position will be employed for the conduct of regional block. The block will be performed at T4 level using 15ml of 0.375% Ropivacaine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1.Patients undergoing breast surgery under general anaesthesia
2.Patients between 18-70 years

 
 
ExclusionCriteria 
Details  1.Patient refusal to participate.
2.Known hypersensitivity to local anaesthetic and opioids.
3.Patient having an infection at the site of block.
4.Patient having spinal deformities and previous history of spine surgery.
5.Patients on anticoagulation therapy.
6.Patients with untreated psychiatric illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Total analgesic requirements (cumulative morphine consumption )  First 24hrs after suregry in PACU. 
 
Secondary Outcome  
Outcome  TimePoints 
1.11-point NRS scores at rest and at movement in postoperative period at the time interval of 2 hours, 4 hours, 6 hours,12 hours and 24 hours.
2.Duration of analgesia (time for the first analgesia injection in postoperative period).
3.Postoperative nausea and vomiting at 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.
4.Adverse events in 24 hours
5.Patient satisfaction score.

 
1.To assess the post-operative pain using NRS scale at 2 hours , 4 hours , 6 hours , 12 hours and 24 hours.
2.Postoperative nausea and vomiting at 2 hours , 4 hours , 12 hours and 24 hours.
3.Adverse events in 24 hours. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   01/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

All selected patients will undergo a routine preanesthetic assessment with one day prior to surgery. All patients will be explained about the blocks and study methodology, including the advantages of postoperative pain relief. The patient information sheet will be provided to all, and informed written consent from all patients will be obtained. Patients will be taught to express pain by using a 11-point NRS (Numeric Rating Scale), in which they will be asked to encircle a number between 0 and 10 that would fit best to their pain intensity other where 0 represents ‘no pain at all’ and ten means ‘worst pain ever possible’. Patient will be trained and counselled regarding functioning and operability of the PCA pump during the preanesthetic visit.

            Standard fasting guidelines [WHO] will be followed for all patients. All patients will be premedicated with Tab Alprazolam 0.25mg orally the night before the day of surgery. On the day of surgery, the Anaesthesia Machine will be thoroughly checked, and the availability of appropriate airway equipment will be ensured.

              Baseline parameters, heart rate, non-invasive blood pressure (NIBP), oxygen saturation (SpO2), and respiratory rate (RR) will be recorded before the anaesthetic induction. Patients will be allotted to one of the two groups depending on a computer-generated random number table. Allocation concealment will be ensured by enclosing assignments in sealed, opaque, sequentially numbered envelopes, which will be opened only upon the patient’s arrival in the operation room.

             Both the regional blocks will be performed by the investigator before induction and the patient will not know about the type of intervention and an anaesthesiologist blinded to the study groups will be responsible for postoperative follow up. Hence, it will be conducted as a double blind study.

           Both the blocks will be performed in pre anesthesia room with facilities of monitoring and oxygen. Intravenous access will be secured. Patients will be in sitting position with neck slightly flexed and back arched towards the operator. Same position will be employed for the conduct of regional block. The block will be performed at T4 level using 15ml of  0.375% Ropivacaine.

         The intervention will be carried out using the ( Sonosite Edge , Sonosite , Inc, Bothell, WA) ultrasound machine placed on the right side of the patient and the investigator will be performing by standing on the left side of the patient. A linear transducer (5-12 MHz) will be used and transducer will be covered using a sterile sheath. Both the  blocks will be performed under aseptic precautions, parts will be sterilized using chlorhexidine and draped, exposing the area of intervention. An echogenic , 80-mm, 22- gauge block needle ( Pajunk SonoTAP, Geisingen , Germany).


 

 

 

GROUP 1: USG-TPVB

               The high frequency(5-12MHz) linear transducer probe will be oriented in identifying the the spinous process of  T2 to T6. After identifying the T4 vertebrae, the probe is placed 2.5 cm lateral to the T4 spinous process. The transverse processes and ribs are visualized as hyperechoic structures with acoustic shadowing below them. Once the transverse processes and ribs will be identified, the transducer will be moved slightly caudal into the intercostal space between adjacent ribs to identify the thoracic paravertebral space. The space appears as a wedge-shaped layer demarcated by the hyperechoic reflections of the pleura below and the internal intercostal membrane above. The thoracic paravertebral space will be identified at this point.

             At the puncture site, infiltration will be done subcutaneously with 3-4 ml 2% lignocaine using a 22G needle. The block needle will be inserted below the probe in an in-plane approach under ultrasound guidance to reach the paravertebral space under vision and the needle will be advanced perpendicular to the skin in all planes until the transverse process is contacted. Once the transverse process is located, the needle is withdrawn to the subcutaneous tissue and readvanced in a cephalad direction to pass through the space between the two transverse processes until loss of resistance(LOR) will be elicited as the needle traverses the SCTL, usually within 1.5 to 2cm from transverse process. The LOR felt as the needle enters the TPVS, is subjective and indefinite. After aspiration of the syringe, 15 ml of 0.375% Ropivacaine without any adjuvant will be injected in TPVS  under ultrasound guidance which will result in anterior displacement of pleura.

   

 

 

GROUP 2: USG-CTFB

             In CTFB intervention, the T4-T5 thoracic spinal level will be identified using high frequency linear transducer (5-12 MHz) oriented in a parasagittal plane counting down from the first thoracic vertebra to the first rib junction. The positions of the fourth and fifth ribs will be identified and marked with the transducer orientated longitudinally. The transducer will be  guided in a lateral to medial direction while maintaining a parasagittal orientation and observing for the transition from ribs to the TP. The transducer will be  moved medially to identify the base of the TP, a slight step-down from the hyperechoic shape of the TP. The pleural structure can be  determined in this view by gradually moving deeper and away from the TP.

            The injection procedure will be  performed using an inplane technique under real-time ultrasound guidance. An 23-gauge block needle will be directed caudad-to-cephalad until the needle tip contacted the anteroinferior part of the base of the T4 TP. The correct needle tip position was confirmed by the injection of 1.5 to 2 mL of 0.9% normal saline solution to visualize the spreading from posterior to anterior following which 15 ml of 0.375% ropivacaine will be injected over 1-2 minutes under real time ultrasound guidance.

     

     Induction. of anaesthesia will be achieved with Intravenous (IV) morphine 100 mcg/kg followed by IV Propofol 2mg/kg. Intubation of the trachea will be facilitated by Atracurium (0.5mg/kg). The airway will be secured by appropriate size Endotracheal Tube (ETT), and the position of ETT will be confirmed clinically by 5-point auscultation and with capnography. Anaesthesia will be maintained with oxygen and isoflurane with a target MAC of 0.8-1.2. Boluses of Atracurium will be administered accordingly to maintain muscle relaxation. If tachycardia occurs > 20% of baseline, or mean arterial pressure increases by > 20% of baseline, 25mcg/kg bolus of morphine is given. IV Acetaminophen 1g will be given as intraoperative analgesia.

Injection Ondansetron 4 mg will be administered approximately 10 minutes before skin closure  & residual of neuromuscular (NM) blockade will be reversed by Inj. Neostigmine 50µg/kg IV and Inj. Glycopyrrolate 10µg/kg IV. Tracheal extubation will be done after confirmation of adequate neuromuscular recovery. The patient will be shifted to PACU, wherein the NRS scores will be noted at 2 hours, 4hours, 6 hours, 12 hours, 24 hours at rest, on coughing, and change of posture.  A change on the NRS of 20% between two time-points of an assessment is regarded as being clinically significant.

Postoperative analgesia will be provided with Morphine IV by a Patient Controlled Analgesia (PCA) pump (in the first 24 hours), which will be set to deliver a bolus of 1mg with a lockout interval of 10 minutes and a 10mg 4 hours limit. The time to the first bolus dose will be recorded as the first analgesic requirement during the first 24 hours.

Paracetamol 1g IV is given eighth hourly to all patients in both groups for 24 hours. Total opioid consumption during the 24 hours postoperative period will be recorded at 2 hours, 4hours, 6 hours, 12 hours and 24 hours.

Patient will be observed for any adverse events, example: PONV, respiratory depression and pruritus.

The number of episodes of PONV will also be noted for the first 24 hours. The PONV scoring will be done at 2 hours, 4hours, 6 hours, 12 hours, and 24 hours.

·       0 = no nausea or vomiting

·       1 = nausea but no vomiting

·       2 = vomiting once in 30 minutes

·       3 = two or more episodes of vomiting in 30 minutes

If the patient has nausea or vomiting, IV Ondansetron 4-6mg will be administered. In case of inadequate relief, IV metoclopramide 10 mg will be administered.

Routine hemodynamic monitoring and SpO2 and respiratory rate will be done in the first 24 hours to maintain Spo2 of >94% with O2 supplementation if needed by the patient and respiratory rate >10/minute. The patient will be said to be having respiratory depression if any one of the following variables [respiratory frequency <8/min, SpO2 < 90% (with supplementary oxygen by facemask at 5litres/min] are present. If the patients experience pruritus, IV naloxone 0.25-1 mcg/kg will be administered for its management.

Patient satisfaction with the technique will be assessed 24 hours after the operation on an 11-point patient satisfaction score (0-unsatisfied, 10-most satisfied).

 
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