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CTRI Number  CTRI/2017/07/008987 [Registered on: 06/07/2017] Trial Registered Retrospectively
Last Modified On: 27/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between two pain reducing technique after operation 
Scientific Title of Study   A comparison of two techniques of postoperative analgesia: lignocaine-fentanyl intravenous infusion and ropivacaine-fentanyl epidural infusion in patients undergoing major abdominal oncosurgery- a randomized control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rudranil Nandi 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Onco-anesthesia Dr. BRAIRCH AIIMS New Delhi- 110029

South
DELHI
110029
India 
Phone    
Fax    
Email  drrudranilnandi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Mishra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Onco-anesthesia Dr. BRAIRCH AIIMS New Delhi- 110029

South
DELHI
110029
India 
Phone    
Fax    
Email  seemamishra2003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rudranil Nandi 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Onco-anesthesia Dr. BRAIRCH AIIMS New Delhi- 110029

South
DELHI
110029
India 
Phone    
Fax    
Email  drrudranilnandi@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  AIIMS 
Address  AIIMS New Delhi- 110029 
Type of Sponsor  Government 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 Rudranil Nandi  AIIMS  OT complex Department of Oncoanaesthesia Dr. BRAIRCH, AIIMS New Delhi- 110029
South
DELHI 
9564713195

drrudranilnandi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  With diagnosis of abdominal malignancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group EPI  Epidural Ropivacaine and fentanyl infusion 
Intervention  Group IV  IV lignocaine and fentanyl infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age of 18 years or older, but less than 70 years.
2. Clinical diagnosis of primary abdominal malignancy.
3. Agree to receive postoperative patient-controlled analgesia.
4. Agree to participate in the study and have signed written informed consent.
 
 
ExclusionCriteria 
Details  1. Complicated with mental illness, severe heart disease (NYHA classification 3), any renal or hepatic disorder before surgery.
2. Contraindications of epidural anesthesia.
3. Allergic to any drug used during the study.
4. Patients who are likely to be electively ventilated in postoperative period.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rescue analgesia in post operative period  Rescue analgesia in post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain score  1,2,4,8,12,18,24 hrs post operative period. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 30/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Postoperative recovery depends on the quality of perioperative pain relief. Different types of analgesic strategies are used in perioperative period for the patients undergoing major abdominal oncosurgery. Commonly used methods are intravenous (IV) opioid analgesia and epidural analgesia. IV lignocaine infusion in perioperative period is also found to be beneficial for patients for its analgesic, antihyperalgesic and anti inflammatory property. It is very difficult to stamp any strategy as best strategy. There is very limited data available in the literature regarding intravenous infusion of lignocaine and fentanyl simultaneously in the perioperative period. In this study we are planning to compare analgesic efficacy of intravenous lignocaine-fentanyl infusion with epidural ropivacaine-fentanyl infusion.

Patients will be randomized either in the epidural group (Group EPI) or intravenous group (Group IV). All patients will be given GA.In group EPI, epidural catheter will be placed as per incision congruent technique before induction. Placement of the catheter will be checked by 3 ml of 2% lignocaine with adrenaline (1:200000). Epidural analgesia will be activated by 0.15 ml/kg of Ropivacaine 0.2%. After 15 min of epidural drug dose anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 mcg/kg and rocuronium 0.6 mg/kg. After induction patients will be received continuous epidural analgesia with a solution containing ropivacaine 0.2%  and fentanyl 2 mcg/ml at the rate of 0.1 ml/kg/hr. If the patient’s heart rate increases above 20% or SPI above 60 then rescue analgesia will be administered with fentanyl 25 mcg. After the completion of the surgery rate of epidural infusion will be same but the strength of the ropivacaine will be 0.1% instead of 0.2% and fentanyl will be 1 mcg/ml.

In group IV no epidural catheter will be placed. Anaesthesia will be induced with propofol, fentanyl and rocuronium. Just before induction lignocaine bolus dose will be given at a dose of 1.5 mg/kg. Intraoperatively patient will be received lignocaine infusion at 1 mg/kg/hr and fentanyl infusion at 0.5 mcg/kg/hr. If the patient’s heart rate increases above 20% or SPI above 60 then rescue analgesia will be administered with fentanyl 25 mcg. After the completion of the surgery lignocaine infusion will be given at the dose of 0.5mg/kg/hr and fentanyl infusion will be given at the dose of 0.25 mcg/kg/hr.

In both the groups anesthesia will be maintained with desflurane in a mixture of air 40% and O2 60%, and end-tidal concentration of desflurane will be adjusted depending upon the vital parameters. Systolic blood pressure(SBP) will be maintained within 20% of baseline values, and hypotension (SBP<90 mmof Hg) will be treated with IV phenylephrine. If hypotension persist more than 10 mins then analgesic infusion will be reduced by 30%. A thermal blanket will be positioned over the exposed parts of the body to maintain perioperative normothermia. All patients will receive an IV infusion of plasmalyte A at a rate of 8 ml/kg/hour. Thirty minutes before termination of anesthesia intravenous paracetamol at the dose of 15mg/kg will be administered. All the patients will be kept in ICU till 24 hrs in the postoperative period.

In the postoperative period besides their background analgesic infusion through epidural or IV route in group EPI and group IV respectively, all patients will be received fentanyl as rescue analgesia through PCA device. Concentration of fentanyl in PCA device will be 10 mcg/ml, bolus dose will be 20 mcg and lock out time will be 10 min. Patients will receive intravenous fluid with plasmalyte A at the rate of 1.5 ml/kg/hr. If there is hemodynamic compromise [ hypotension (SBP< 90mm of Hg), urine output < 0.5ml/kg/hr] intravenous fluid bolus with 5ml/kg plasmalyte A will be infused and the dose of the continuous analgesia will be reduced by 30% . Same intervention will be repeated if the compromise persists. In both groups multimodal analgesia included intravenous paracetamol 15mg/kg, 4 times a day.

In addition to bradycardia, hypotension, arrhythmia and conduction disturbances, patients will also be monitored postoperatively for the following side effects or symptoms of lignocaine systemic toxicity: circumoral numbness, metallic taste, dizziness, lightheadedness, vision problems, tinnitus, drowsiness, disorientation, twitching, and convulsions. 
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