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CTRI Number  CTRI/2020/04/024743 [Registered on: 20/04/2020] Trial Registered Prospectively
Last Modified On: 17/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of effects of lignocaine infusion on postoperative pain relief for abdominal surgery. 
Scientific Title of Study   Evaluation of effects of intravenous lignocaine infusion on postoperative analgesia after upper abdominal surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokvendra Singh Budania 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy Of Higher Education  
Address  Department of Anaesthesiology Main OT Complex(Division) Room- OR offfice Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9901628947  
Fax    
Email  drbudania@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Eeshwar M V 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy Of Higher Education  
Address  Department of Anaesthesiology Main OT Complex(Division) Room- OR offfice Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9740122272  
Fax    
Email  eeshwar.kmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lokvendra Singh Budania 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy Of Higher Education  
Address  Department of Anaesthesiology Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.


KARNATAKA
576104
India 
Phone  9901628947  
Fax    
Email  drbudania@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital , Manipal Manipal Academy of Higher Education, Manipal,Karnataka , India.PIN 576104  
 
Primary Sponsor  
Name  NA 
Address  NA 
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 
Dr Lokvendra Singh Budania  Kasturba Hospital,Manipal   Department of Anaesthesiology Main OT Complex(Division) Room- OR offfice Kasturba Medical College, Manipal, Manipal Academy Of Higher Education, Manipal.
Udupi
KARNATAKA 
9901628947

drbudania@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group Lignocaine ( Group L)  Patients allotted to lignocaine (group L) will receive bolus dose of lignocaine 1.5 mg/kg through a dedicated intravenous line followed by an infusion@ 1.5mg/kg/hr. Infusion will continue intraoperatively at the same rate until skin closure, following which the rate will be reduced to 1 mg/kg/hr and continue in postoperative period for 24 hours 
Comparator Agent  Group Saline ( Group S)  Patients allotted to Saline (Group S) will receive bolus dose of Saline 1.5 mg/kg through a dedicated intravenous line followed by an infusion@ 1.5mg/kg/hr. Infusion will continue intraoperatively at the same rate until skin closure, following which the rate will be reduced to 1 mg/kg/hr and continue in postoperative period for 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients in age groups 18- 70
Healthy patients belonging to ASA PS I and II
Patients undergoing elective upper abdominal surgery.
 
 
ExclusionCriteria 
Details  Inability to understand preoperative instructions regarding use of PCA pump or pain score
Planned elective postoperative mechanical ventilation
Patients known to be on anti-arrhythmic drug therapy
History of COPD, cardiac, hepatic, renal or nervous system disorder
Known allergy to lignocaine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
TIME INTERVAL between skin closure and first morphine PCA request.
TOTAL MORPHINE CONSUMPTION at the end of 2nd, 6th, 12th, 24th and 36th postoperative hour.
 
Immediate postoperative period
36 hours after surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
PAIN SCORE (NRS) at rest, on deep inspiration, cough and movement (side to side or leg raising) at the end of 2nd, 6th, 12th, 24th and 36th postoperative hour.
Any complaints of –perioral numbness, light headedness.
Sedation level
 
Immediate postoperative period
36 hours after surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/04/2020 
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  

The pain and discomfort after major surgical procedures are well known. Despite advances in knowledge of pathophysiology, pharmacology of analgesics and the development of more effective techniques for post-operative pain control, many patients continue to experience appreciable discomfort. Patients undergoing major abdominal operations experience severe pain and marked respiratory impairment because of pain in the postoperative period.4

We are increasingly becoming aware of the risks associated with the use of invasive techniques in the treatment of postoperative pain. Epidural infusions are certainly more expensive, cumbersome and invasive than intravenous infusions. Furthermore, modern thromboprophylaxis practice with low molecular weight heparins often preclude the use of continuous epidural therapy because of concern over risk of epidural bleeding and hematoma. It is becoming increasingly apparent that local anaesthetic such as lignocaine in the systemic circulation can profoundly alter post-operative pain.  Intravenous lignocaine in the therapeutic dose as used for cardiac arrhythmias treatment, have been shown to reduce postoperative pain scores and opioid consumption; the presence of these drugs in the circulation for only a few hours can suppress pain for days after surgery. Therefore, intravenous lignocaine is appealing as a simple and inexpensive method to gain the same benefits as more invasive and costly techniques.

 
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