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CTRI Number  CTRI/2020/06/025565 [Registered on: 03/06/2020] Trial Registered Prospectively
Last Modified On: 19/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Ropivacaine in the management of post-operative pain. 
Scientific Title of Study   Evaluation of optimal dose of epidural background infusion of Ropivacaine in the management of post-operative pain. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Agarwal 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  A-Block Department of Anaesthesiology SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904589  
Fax    
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Agarwal 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  A-Block Department of Anaesthesiology SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904589  
Fax    
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyotsana Jaiswal 
Designation  Student 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  A-Block Department of Anaesthesiology SGPGIMS Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  6387435694  
Fax    
Email  jaiswal.jyotsana@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Anil Agarwal 
Address  Professor A Bkock Department Of Anaesthesiology SGPGIMS Lucknow  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Anil Agarwal  SGPGIMS,Lucknow  Gastrosurgery OT, OT Complex, First Floor, E block, SGPGIMS Lucknow
Lucknow
UTTAR PRADESH 
8004904589

anil_sgpgi@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, SGPGI  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GROUP WITH 25% OF EPIDURAL DOSE AS BACKGROUND INFUSION  25% of the hourly epiduarl infusion dose will be in the form of background infusion (remaining 75% as demand dose) 
Intervention  GROUP WITH 50% OF EPIDURAL DOSE AS BACKGROUND INFUSION  50% of the hourly epidural dose will be in the form of background infusion( remaining 50% as demand dose) 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients of either sex, ASA physical status I or II, who are scheduled for abdominal surgery under general anaesthesia and thoracic epidural analgesia, will be included in the study. 
 
ExclusionCriteria 
Details  Patient refusal and patients who are unable to understand the numerical rating scale for pain assessment, will be excluded in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-operative NRS score for dynamic pain(coughing)  At 0(zero) hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours, 54 hours,60 hours, 66 hours, 72 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative nausea and vomiting (PONV), reqirement of rescue analgesia and rescue anti-emetic, hypotension, motor block, sedation, pruritis and respiratory depression.  At 0(zero) hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours, 54 hours, 60 hours, 66 hours, 72 hours.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   05/06/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.Hiroshi Komatsu, MD, Shigeru Matsumoto, MD, Hiromasa Mitsuhata, MD, Kyoko Abe, MD, and Sohachi Toriyabe,MD 2.Yamauchi M1, Asano M, Wantanabe M,Iwasaki S, Furuse S,Namiki A. 3.Department of Anaesthesia and Resuscitation , La Paz University Hospital , Madrid ,Spain 4.Kainzwaldener V, et al. Anaesthesist, 2013. 5.Krishan Yogesh Sawheney,Sandeep Kundra ,[…] and Ananjit Kaur  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Despite well-designed concept of perioperative pain management, recent studies have revealed that a large number of patients still suffer from unacceptable pain after surgery. So, for all types of surgery, it has been seen that Continuous Epidural Analgesia (CEA) provide superior analgesia over Patient Controlled Epidural Analgesia (PCEA) for overall pain. However patients receiving CEA had significantly higher incidence of nausea-vomiting and motor block. So, presently the efficacy of Patient Controllrd Epidural Analgesia (PCEA) compared with Continuous Epidural Analgesia (CEA) is not clear. The addition of a continuous background infusion to PCEA following gastrectomy resulted in better dynamic pain scores. So,we designed a prospective, randomised study to evaluate the optimal dose of epidural proportion of epidural demand dose and background infusion in the management of post-operative pain in patients undergoing abdominal sugery.

Patients who met the inclusion criteria during the pre-anaesthetic check up will be randomly assigned into two equal groups of 40 each with the help of a computer generated table of random numbers; each group will receive intra operative epidural catheter placement followed by administration of epidural bolus of (0.1% Ropivacaine + 1mcg/ml Fentanyl combination) and the volume of the bolus shall be 0.1 ml/kg, prior to commencement of surgery; which would be followed by epidural infusion of the same combination @ 0.1ml/kg/hr. In the post - operative period all the patients will receive epidural infusion of the same combinaton @ 0.2ml/kg. The patients will be randomized into one of the following groups:

 Group 1: 50% of the hourly epidural dose will be in the form of background infusion (remaining 50% as demand dose).

 Group 2:  25% of the hourly epidural infusion dose will be in the form of background infusion (remaining 75% as demand dose).

The proportion of background and continuous infusion will be as per the group  allocation. Bolus dose will be 2ml and lock out time interval will be 10 min. Maximum number of boluses will depend upon the total amount of the drug to be administered as bolus depending upon group allocation.

An 18G thoracic epidural catheter would be placed at T8-9 or T9-10 intervertebral space in the operation theatre by an anaesthesiology resident not otherwise involved in the study; the epidural infusion will be started after induction of anaesthesia; standard anaesthesia technique will be used in all patients. Patient’s induction will be done by fentanyl 2-3 mg kg-1 and propofol 1.5-2.5 mg kg-1; orotracheal intubation will be facilitated by vecuronium 0.1 mg kg-1. Anaesthesia will be maintained with propofol, sevoflurane and oxygen air mixture. Hypotension was treated by infusion of isotonic sodium chloride or mephentramine 5 mg intravenously in incremental doses when systolic blood pressure was below 90 mm Hg. At the end of surgery residual neuromuscular paralysis would be antagonized with neostigmine 0.04 mg.kg-1 and glycopyrrolate 0.01 mg.kg1. Following satisfactory recovery, the patients will be extubated and shifted to the post-anaesthesia care unit.


 
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