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CTRI Number  CTRI/2019/11/022006 [Registered on: 14/11/2019] Trial Registered Prospectively
Last Modified On: 06/09/2021
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 postoperative analgesic effect between ultrasound guided transverse abdominis plane block and local infiltration of local anaesthesia-bupivacaine 0.5% at port site in patients undergoing laparoscopic cholecystectomy. 
Scientific Title of Study   Comparison of postoperative analgesic efficacy between ultrasound guided transverse abdominis plane block and local infiltration of bupivacaine 0.5% at port site in laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mathi Sri Akshay 
Designation  MBBS 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research  
Address  Department of general surgery,Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9640737722  
Fax    
Email  sriakshaymathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arulappan T 
Designation  MS General surgery  
Affiliation  Sri Ramachandra Institute Of Higher Education and Research  
Address  Department of General surgery, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9841215453  
Fax    
Email  arulappant9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arulappan T 
Designation  MS General surgery  
Affiliation  Sri Ramachandra Institute Of Higher Education and Research  
Address  Department of General surgery,Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9841215453  
Fax    
Email  arulappant9@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.  
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research Deemed to be University 
Address  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),Porur, Chennai, Tamil Nadu, 600116 
Type of Sponsor  Private 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 
Mathi Sri Akshay   Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)  Department of general surgery, 2 nd floor link, Gblock,Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU 
9640737722

sriakshaymathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Sri Ramachandra institute of higher education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Transverse abdominis plane block is compared with port site infiltration of local anaesthesia in postoperative period as analgesic agent in patients undergoing laparoscopic cholecystectomy  Participants in study were divided into two groups group-A and B. Group-A:- Allotted drug(Bupivacaine 0.5%) for this group will be delivered in the transverse abdominis plane by another anaesthesiologist who is well versed in giving blocks with the aid of an ultrasound. Ultrasound guided subcostal transverse abdominis plane block will be performed bilaterally before surgical incision. Ultrasound probe will be placed transversely in the midaxillary line below the costal margin. The external oblique, internal oblique and transverse abdominis muscle and their fascia will be visualised. A 100 mm needle will be introduced anteriorly and in the plane of the probe and on entering the transverse abdominis plane, 2 ml of saline will be injected to verify the correct position of the needle. After negative aspiration, 20 ml of study drug will be injected and the separation of fascial layer between transverse abdominis and internal oblique is considered as proper placement of the drug. Similarly, subcostal transverse abdominis plane block will be done on the contralateral side. Group-b:- allotted drug for this group will be delivered subcutaneously 5ml at each of the four port sites.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with calculus cholelithiasis.
ASA I, II, III. 
 
ExclusionCriteria 
Details  Patient non compliance
Heart rate<60 bpm
Baseline systolic bp <100mmhg
BMI<18 or >35 kg/m2
Allergic to study drugs
Infection at injection site
Coagulopathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr.
If pain score more than 4, rescue analgesia will be given.
Inj Paracetamol 1 gm IV will be first line analgesic.
If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic. 
Pain will be assessed using visual analogue scale(VAS) at postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr.
If pain score more than 4, rescue analgesia will be given.
Inj Paracetamol 1 gm IV will be first line analgesic.
If no relief with Inj Paracetamol 1 gm in 30 min, Inj. Diclofenac 75mg IM is given as second line analgesic. 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative Spo2 monitoring will be done for every 30mins for first 24hrs.  Postoperative 30mins, 1hr, 2hrs, 4hrs, 8 hr. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/11/2019 
Date of Study Completion (India) 16/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 11/06/2020 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
This study will be published after completion of study 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Patients coming for laparoscopic cholecystectomy who fit into the inclusion criteria will be included in the study. Patients enrolled in the study will be explained about the study drugs and the possible advantages and disadvantages and their consent will be obtained. Patients will be assessed on the previous day and nil per oral orders for atleast 8 hours will be maintained.

 

On day of surgery, patient will be brought to the or , baseline monitors will be connected and baseline vitals will be recorded.

The study drugs will be prepared by an anaesthesiologist who is not involved in the study.

Group-A:- allotted drug for this group will be delivered in the transverse abdominis plane by another anaesthesiologist who is well versed in giving blocks with the aid of an ultrasound. Ultrasoundguided subcostal transverse abdominis plane block will be performed bilaterally before surgical incision. Ultrasound probe will be placed transversely in the midaxillary line below the costal margin. The external oblique , internal oblique and transverse abdominis muscle and their fascia will be visualised. A 100 mm needle will be introduced anteriorly and in the plane of the probe and on entering the transverse abdominis plane , 2 ml of saline will be injected to verify the correct position of the needle. After negative aspiration , 15 ml of study solution will be injected and the separation of fascial layer between transverse abdominis and internal oblique is considered as proper placement of the drug. Similarly  subcostal transverse abdominis plane block will be done on the contralateral side.

 

Group-B:- allotted drug for this group will be delivered

Subcutaneously 5ml at each of the four port sites.

 

 

Intraoperative haemodynamics will be monitored and recorded . We will assess the post operative pain and the need for rescue analgesics in the immediate post operative period. If vas score >4  in the post anaesthesia care unit(1hr post operatively) in patients who received tap block will be considered to have block failure and such patients will be excluded from the study.

 

Analysis

Pain to be assessed using visual analogue scale(vas).

Pain scores to be assessed at 30mins, 1hr,2hrs, 4 hrs, 8 hrs.

If pain score more than 4, rescue analgesia will be given.

Post operative spo2 monitoring every 30mins, for 24hrs.

 

rescue analgesia

Inj paracetamol 1 gm iv, if no relief  with inj paracetamol in 30 min

Inj diclofenac 75mg im will be given . 

        primary outcome

Vas score post operatively

Duration of post operative analgesia

(duration is the time from performance of block/local infiltration to the first pain score =>4 . )

 secondary outcome

Time for first rescue analgesia

Number of doses of rescue analgesia given

Postoperative oxygen saturation monitoring.

 

 


 
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