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CTRI Number  CTRI/2017/02/007936 [Registered on: 21/02/2017] Trial Registered Retrospectively
Last Modified On: 30/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   thoracic paravertebral versus oblique subcostal transversus abdominius plane block for open cholecystectomy. 
Scientific Title of Study   Efficacy of Thoracic paravertebral block with oblique subcostal Transversus abdominus plane block in open cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Seema jindal 
Designation  Assistant professor 
Affiliation  GGS medical college Faridkot. 
Address  H.no 42 medical campus sadiq road faridkot.

Faridkot
PUNJAB
151203
India 
Phone  9646050485  
Fax    
Email  jindalseema77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gurkaran kaur sidhu 
Designation  Assistant professor 
Affiliation  GGS Medical College Faridkot. 
Address  H.no 76 medical campus sadiq road faridkot.

Faridkot
PUNJAB
151203
India 
Phone  9876766522  
Fax    
Email  sugarsidhu2007@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gurkaran kaur sidhu 
Designation  Assistant professor 
Affiliation  GGS Medical College Faridkot. 
Address  H.no 76 medical campus sadiq road faridkot.

Faridkot
PUNJAB
151203
India 
Phone  9876766522  
Fax    
Email  sugarsidhu2007@rediffmail.com  
 
Source of Monetary or Material Support  
Guru Gobind Singh Medical College and Hospital,Sadiq Road.Faridkot. Punjab151203 
 
Primary Sponsor  
Name  Guru Gobind Singh Medical College and Hospital 
Address  Sadiq road,Faridkot.Punjab 151203. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Baba Farid University of Health Sciences faridkot  GGS Medical College And Hospital ,Sadiq Road Faridkot. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Seema jindal  Guru Gobind Singh Medical College and Hospital.  Department of Anaesthesia and Crital Care.
Faridkot
PUNJAB 		 9646050485
9646050485
jindalseema77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Baba Farid university of health sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oblique subcostal TAP block  Efficacy ofThoracic Paravertebral Block With Oblique Subcostal Transversus Abdominius Plane Block in Open Cholecystectomy. 
Intervention  Thoracic paravertebral block  Thoracic Paravertebral Block And Oblique Subcostal Transversus Abdominus Plane Block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)elective open cholecystectomy due to surgical indications ( previous abdominal surgery ,
2) suspected GB mass, thickened wall of gall bladder) will be enrolled in the study. 
 
ExclusionCriteria 
Details  1) patient refusal
2) intellectual disability
3) any contraindication for regional anesthesia like infection at puncture site
4) anatomical deformity such as kyphyscolisosis.
5) coagulation disorders
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare analgesic efficacy of oblique subcostal TAP block with thoracic paravertebral block intraoperatively and postoperatively at 2,4,8,12,24 and 48 hrs by VAS scale at rest ,on movement and on coughing.The time for first rescue analgesia and the total number of doses of rescue analgesia required in 48 hrs will be noted.  At 2,4,8,12,24 and 48 hrs . 
 
Secondary Outcome  
Outcome  TimePoints 
to assess number of patients free of nausea or vomiting at the same predetermined time interval as used for pain assessment  At 2,4,8,12,24 and 48hrs. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   01/10/2016 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A chief component in contributition to the pain experienced after abdominal surgery is from the incision in the abdominal wall and parietal peritonium pain and less from internal visceral trauma. Intraoperative and postoperative pain following upper abdominal surgeries including open cholecystectomies can be controlled with systemic opioids ,epidural analgesia, NSAIDS,and peripheral nerve blocks like thoracic paravertebral or Oblique subcostal transversus block. Both block will be performed under USG guidance using high frequency probe covered with protective sheath. Patients will be assessed  intraoperatively and postoperatively for 48 hr for analgesic and antiemetic requirement. Note will be made of number of doses of rescue analgesia and time for first rescue analgesia.

 
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