FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/015980 [Registered on: 10/10/2018] Trial Registered Prospectively
Last Modified On: 07/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different analgesic techniques for chest surgeries 
Scientific Title of Study   Comparison of postoperative analgesia by two different technique of paravertebral block: Conventional v/s Mid transverse process to pleura in Video assisted thoracic surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Kamal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Basni Phase 2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Manoj Kamal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Basni Phase 2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Swathi KB 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Basni Phase 2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8197208947  
Fax    
Email  swathikb92@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Jodhpur 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR 
Address  BASNI PHASE 2 JODHPUR 342005 
Type of Sponsor  Government 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 MANOJ KAMAL  AIIMS, Jodhpur  BASNI PHASE 2 JODHPUR
Jodhpur
RAJASTHAN 
9414084584

geetamanoj007@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee, All India Institute of Medical Sciences Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J852||Abscess of lung without pneumonia, (2) ICD-10 Condition: J851||Abscess of lung with pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CONVENTIONAL GROUP (CP)  Thoracic paravertebral block (TPVB) at T4 level by conventional approach 0.2% ropivacaine , 20 ml in paravertebral space 
Comparator Agent  Modified paravertebral (MP) group   Thoracic paravertebral space by Mid transverse process to pleura approach at T4 level, 0.2% ropivacaine 20 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients belonging to American Society of Anesthesiologists (ASA) physical status grade I or II
2.aged between 18 to 60 years
3.scheduled to undergoing VAT surgeries. 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Preexisting infection at block site
3.Coagulation Disorder
4.History of psychiatric illness and preexisting neurological deficits
5.Patient with morbid obesity BMI >40 kg/ m2
6.Decreased pulmonary reserve, cardiac disorders and renal dysfunctions
7.Known allergy to study drugs
8.Presence of any preoperative pain or history of chronic pain
9.History of regular analgesic use
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To asses 24 hour analgesic consumption  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of analgesia, complication,duration to perform block, failure rate and patient satisfaction  24 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) 07/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Submitted in Korean Journal of Anaesthesiology 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  


 This study will be carried out in Department of Anesthesiology & Critical care AIIMS Jodhpur after institution ethical approval.

Inclusion Criteria

·         Patients belonging to American Society of Anesthesiologists (ASA) physical status grade I or II aged between 18 to 60 years scheduled to undergoing VAT surgeries.

Exclusion Criteria

1.      Patient refusal

2.      Preexisting infection at block site

3.      Coagulation Disorder

4.      History of psychiatric illness and preexisting neurological deficits

5.      Patient with morbid obesity BMI >40 kg/ m2

6.      Decreased pulmonary reserve, cardiac disorders and renal dysfunctions

7.      Known allergy to study drugs

8.      Presence of any preoperative pain or history of chronic pain

9.      History of regular analgesic use

 

During the preoperative visit a day before surgery, all patients will thoroughly explained about the procedure. They will also made well conversant about visual analogue score (VAS 0–10, 0= no pain, 10= worst pain). Patients will be randomly allocated by using computer generated random number method into two groups in 1:1 allocation ratio. The group allocation numbers will be concealed in sealed opaque envelopes that will be opened just before the performance of block. Group conventional (CP) group patients will receive TPVB at T4 level by conventional approach, whereas Group modified (MP) technique patients will receive TPVB by MTP approach at T4 level unilaterally on the operative side. In both groups block will be performed under ultrasound guidance and receive 20 ml 0.2% ropivacaine.

     In the procedure room, routine monitors will be attached and baseline vitals recorded. All the patients will receive premedication with intravenous (IV) midazolam (0.04–0.06 mg/kg) and fentanyl (1µg/kg) IV.

Conventional approach of thoracic PVB - TPVB will be administered at the T4 level on the side of surgery with the patient in the sitting position. The high frequency ultrasound probe (LOGIQe, GE Healthcare, China) will be placed 3-4cm from the midline in the cephalad-caudal direction and identify the transverse process, parietal pleura and superior costotransverse ligament (SCTL). The skin will be infiltrated with 2% lidocaine followed by ropivacaine 0.2%, 20 ml will be deposited in paravertebral space  by block needle (8 cm Contiplex, B Braun) after piercing   of SCTL and then catheter will be inserted in the paravertebral space 3 cm distal to needle tip. After insertion of catheter, infusion (0.2% ropivacaine) at the rate of 0.1ml/kg/hr will continued throughout intraoperative period.

MTP approach of thoracic PVB-MTP block will be performed at T4 level on the operative side by using high frequency ultrasound probe (LOGIQe, GE Healthcare, China) with parasagittal scan, in-plane technique and with needle direction from caudal to cephalic. Local anesthetic will be deposited at the mid-point between the posterior border of the transverse process and the pleura (superficial to the SCTL). A total of 20 ml of 0.2% ropivacaine will be injected, followed by catheter insertion 3 cm distal to needle tip. After insertion of catheter, infusion (0.2% ropivacaine) at the rate of  0.1ml/kg/hr will continued throughout intraoperative period.

Assessment of block: postoperative fentanyl requirement will be noted and if more than 2 doses of fentanyl at the rate of 1 mcg/ kg is required in consecutive 4 hours than it will be labeled as block failure

Anesthetic technique: After arrival in the operation theatre, routine monitoring will be continued. Following pre-oxygenation, anesthesia will be induced with fentanyl 2 mcg/kg and propofol 2 mg/kg and rocuronium 0.5 mg/kg and an appropriate sized endotracheal tube will be inserted. Maintenance of anesthesia will be achieved with isoflurane in oxygen and air mixture (MAC 0.8-1.0). Heart rate (HR), oxygen saturation (SpO2)and mean blood pressure (MBP) will be continuously monitored throughout the surgery.  Ondansetron 4mg IV will be administered as prophylactic antiemetic to all patients. At the end of surgery, all patients will be reversed as per usual protocol. The patients will be shifted to post anesthesia care unit (PACU) and further to ward and will be monitored at regular intervals for 24 h after surgery.

Complications related to procedure or drugs used will be recorded (pneumothorax, local anesthetic toxicity )

Postoperative pain intensity will be measured using VAS (1–10) at 1, 3, 6, 12, 18 and 24 h by an independent observer who is not known about study group. Injection fentanyl 1 mcg/kg will be used as rescue analgesic, if VAS score ≥4 is recorded or on patient demand.  Time to first rescue analgesia and total amount of analgesics used in 24 h postoperatively will be recorded.

.At 24 h after surgery, satisfaction of the patients will be assessed using a numerical satisfaction score as 4= excellent, 3=good, 2=fair, 1=poor.


 
Close