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CTRI Number  CTRI/2024/05/068030 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical interventional trial comparing a Regional block-External oblique intercostal Plane block against port site local infiltration in evaluating the postoperative pain management.The participants include laparoscopic right donor nephrectomy patients. 
Scientific Title of Study   Comparison of Externaloblique intercostal Planeblock vs port site infiltration in laparoscopic right donor nephrectomy  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ParkaviV 
Designation  DNB Anaesthesiology  
Affiliation  Kovai Medical Center and Hospital  
Address  Department of anesthesia, Ot complex 1,2nd Floor, Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore.

Coimbatore
TAMIL NADU
641014
India 
Phone  09488806637  
Fax    
Email  parkavivainan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Balaji.P.R 
Designation  DNB Anaesthesiology  
Affiliation  Kovai Medical Center and Hospital  
Address  Department of anesthesia, Ot complex 1,2nd Floor, Kovai Medical Center and Hospital,99 Avinashi road, Coimbatore.

Coimbatore
TAMIL NADU
641014
India 
Phone  9843268425  
Fax    
Email  balaji.dr@gmail.com  
 
Details of Contact Person
Public Query  
Name  ParkaviV 
Designation  DNB Anaesthesiology  
Affiliation  Kovai Medical Center and Hospital  
Address  Department of Anesthesia, Ot complex 1, 2nd floor, Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore.

Coimbatore
TAMIL NADU
641014
India 
Phone  09488806637  
Fax    
Email  parkavivainan@gmail.com  
 
Source of Monetary or Material Support  
Kovai Medical Center and Hospital,99 Avinashi road, Coimbatore-641014 Tamilnadu,India.  
 
Primary Sponsor  
Name  ParkaviV 
Address  Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore-641014, Tamilnadu, India. 
Type of Sponsor  Other [Self] 
 
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 
DrParkaviV  Kovai Medical Center and Hospital   Department of Anesthesia, Ot complex 1, 2nd Floor, Kovai Medical Center and Hospital,99 Avinashi road, Coimbatore
Coimbatore
TAMIL NADU 		 9488806637

parkavivainan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee - Kovai Medical Center and Hospital, No 99, Avinashi road, Coimbatore.  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  External oblique intercostal Planeblock   Study duration: 2 years (may 2024- may 2026) Under ultrasound guidance, Regional anesthesia - External oblique intercostal Plane Block will be performed using 30 ml of 0.5% Ropivacaine in donor nephrectomy patients at the time of extubation.  
Comparator Agent  Local infiltration at port site.  Study duration 2 years ( may 2024 to May 2026) Local infiltration using 30 ml of 0.5% Ropivacaine will be injected at Port site in control group at the time of extubation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age above 18 and below 70
Physical status classification:ASA1and ASA2
Both male and female
Patients who are willing to participate  
 
ExclusionCriteria 
Details  Patients refusal
Allergic to local anaesthetic
History of multiple previous abdominal surgery  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the analgesic effect of Externaloblique intercostal Planeblock with 0.5% Ropivacaine in laproscopic right donor nephrectomy.  Pain is evaluated using Numerical rating scale at the time of extubation and at 1 hr, 3 hrs, 6 hrs, 12 hrs after extubation  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the efficacy of external oblique intercostal Planeblock & local infiltration in reducing the usage of opioids   Opioids usage time is noted at 3,6,12 hrs after extubation  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   02/06/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 08-05-2024 and end date provided 08-05-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is a prospective compartive study comparing the analgesic effect of external oblique intercostal Planeblock  vs local infiltration in patients undergoing laparoscopic right donor nephrectomy.The study will be conducted in Kovai Medical Center and Hospital, Coimbatore.After getting informed written consent from the patients ,they will divided into 2 groups. One will be receiving External oblique intercostal Planeblock and the other will receive local infiltration at port  site. Primary outcome is  analgesic effect of block will be assessed using Numerical rating scale . Secondary outcome is effect of block in reducing the usage of opioids postoperatively. 
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