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CTRI Number  CTRI/2019/04/018489 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 04/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison between two different drug combinations for pain relief after kidney surgery 
Scientific Title of Study   Comparitive study between ropivacaine plus dexmedetomidine versus ropivacaine plus magnesium sulfate in ultrasound guided transversus abdominis plane block “TAP” in post operative pain management after laproscopic nephrectomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj v patel 
Designation  Anesthesiologist 
Affiliation  muljibhai patel urological hospital, nadiad 
Address  muljibhai patel urological hospital, OT complex , ground floor , department of anesthesia, V R desai road , nadiad

Kheda
GUJARAT
387001
India 
Phone  8128600624  
Fax    
Email  pankajpatel_81@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj v patel 
Designation  Anesthesiologist 
Affiliation  muljibhai patel urological hospital, nadiad 
Address  muljibhai patel urological hospital, OT complex , ground floor , department of anesthesia, V R desai road , nadiad

Kheda
GUJARAT
387001
India 
Phone  8128600624  
Fax    
Email  pankajpatel_81@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj v patel 
Designation  Anesthesiologist 
Affiliation  muljibhai patel urological hospital, nadiad 
Address  muljibhai patel urological hospital, OT complex , ground floor , department of anesthesia, V R desai road , nadiad

Kheda
GUJARAT
387001
India 
Phone  8128600624  
Fax    
Email  pankajpatel_81@yahoo.co.in  
 
Source of Monetary or Material Support  
muljibhai patelurological hospital, nadiad 387001 
 
Primary Sponsor  
Name  muljibhai patel urological hospital 
Address  OR complex , ground floor , V R desai road, nadiad, 387001 
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 pankaj patel  muljibhai patel hospital operation theater  OR complex , ground floor , muljibhai patel urological hospital , nadiad , 387001
Kheda
GUJARAT 		 8128600624

pankajpatel_81@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
MPSRNUEC  Approved 
MPSRNUEC  Approved 
MPSRNUEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ropivacaine, dexmeditomidine, magnesium sulfate  anesthesia drugs injected between internal oblique and transversus abdominis muscle (TAP plane). effect of pain relief will be assesed for 24 hours in postoperative period. 
Intervention  ultrasound guided TAP block  ultrasound guided TAP block for pain relief 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  – patients undergoing laproscopic nephrectomy ( simple , radical , donor ) between age group 18- 60 years , patients with ASA
( American society of anesthesiology) grade 1 and I1.
 
 
ExclusionCriteria 
Details  - Patients not willing, patient’s age below18 and above 60 years, with deranged coagulation profile, with infection at the site of block, with allergy to any of the drugs to be used in study, and patients with severe cardio respiratory disease will be excluded from the study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative pain relief(visual analogue scale scale)  immidiate postoperative period and in recovery and step down recovery room. 
 
Secondary Outcome  
Outcome  TimePoints 
nausea , vomiting  post operative period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 1 
Date of First Enrollment (India)   15/04/2019 
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)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Laparoscopic nephrectomy is one of the commonly performed surgical procedures that is associated with a moderate degree of postoperative pain especially on the 1st postoperative day. Adequate postoperative analgesia allows early patient ambulation, decreases analgesic requirements, and hospital length of stay.  Ultrasound guided Transversus abdominis plane (TAP) block is a recent analgesic technique that has proved its efficacy in perioperative pain therapy for Laparoscopic nephrectomy surgery.The aim of this study will be to compare addition of dexmedetomidine to ropivacaine  versus magnesium sulfate to ropivacaine  in ultrasound guided TAP block on postoperative pain scores (primary outcome) , time to first rescue analgesia, total analgesic requirement and postoperative nausea and vomiting (PONV) (secondary outcomes) in the patients undergoing Laparoscopic nephrectomy surgery .

The aim of this study will be to compare addition of dexmedetomidine to ropivacaine  versus magnesium sulfate to ropivacaine  in ultrasound guided TAP block on postoperative pain scores (primary outcome) , time to first rescue analgesia, total analgesic requirement and postoperative nausea and vomiting (PONV) (secondary outcomes) in the patients undergoing Laparoscopic nephrectomy surgery .


 
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