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CTRI Number  CTRI/2016/08/007200 [Registered on: 17/08/2016] Trial Registered Prospectively
Last Modified On: 17/08/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Prolonged postoperative surgical pain after laparoscopic cholecystectomy 
Scientific Title of Study   Incidence of chronic postoperative surgical pain after laparoscopic cholecystectomy:A comparison between dexmedetomidine- fentanyl and propofol-fentanyl based total intravenous anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Himabindu 
Designation  Post-graduation (MD), Anaesthesiology 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Dr. Aloka Samantaray Additional professor Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9490713247  
Fax    
Email  himabindukotamarthy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Himabindu 
Designation  PG student 
Affiliation  Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati 
Address  Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati

Chittoor
ANDHRA PRADESH
517507
India 
Phone    
Fax    
Email  himabindukotamarthy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aloka Samantaray 
Designation  Additional professor 
Affiliation  Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati 
Address  Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati

Chittoor
ANDHRA PRADESH
517507
India 
Phone    
Fax    
Email  aloksvims@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara institute of Medical Sciences 
 
Primary Sponsor  
Name  DirectorSri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati.517507  
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 Aloka Samantaray  Sri Venkateswara Institute of Medical Sciences  Department of Anaesthesiology & Critical Care
Chittoor
ANDHRA PRADESH 
9493547653

aloksvims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Inclusion criteria: Scheduled for elective laparoscopic cholecystectomy Patients aged 18-60 years American Society of Anesthesiologists Physical Status I & II ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine-fentanyl froup  Induction with injection dexmedetomidine 1mcg/kg slowIV over 10 minutes and maintenance with 0.3-1mcg/kg dexmedetomidine along with fentanyl infusion at rate of 1mcg/kg/hr. 
Intervention  Propofol-fentanyl group  Induction with injection propofol 1.5mg/kg IV and maintenance with 3-12mg/kg/h propofol infusion along with fentanyl infusion at rate of 1mcg/kg/hr. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Day(s)
Gender  Both 
Details  Inclusion criteria:
Scheduled for elective laparoscopic cholecystectomy
Ppatients aged 18-60 years
American Society of Anesthesiologists Physical Status I & II15
 
 
ExclusionCriteria 
Details  Exclusion criteria:
Chronic opioid users
Pre-existing pain syndrome
Severe cardiovascular(New York Heart Association class III or IV)
Severe pulmonary and renal disease
Inability to communicate and understand Pain scale(Visual analogue scale)
Pregnant and lactating mothers
Patients not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Primary objective is to find out the incidence of chronic post-operative surgical pain(CPSP) after laparoscopic cholecystectomy  At 1st,2nd,3rd and 4th months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
2. Secondary objective is to compare the
(1)incidence of CPSP and (2)recovery profile between two different types of TIVA. 
(1)1st ,2nd ,3 rd and 4th month after laparoscopic cholecystectomy
(2)Post operative period (time frame 0-24h)  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/09/2016 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

     Persistence of pain is less common after laparoscopic cholecystectomy(LC) than open cholecystectomy(OC).Incidence of persistent pain symptoms after LC is 13%. where as incidence of chronic post operative surgical pain (CPSP) after OC cholecystectomy is around 3-51%4. Laparoscopic cholecystectomy being carried out as a day care procedure but very little is known about the actual incidence of CPSP after this procedure.Total intravenous anaesthesia (TIVA) is better compared to general anaesthesia in terms of better hemodynamic stability, recovery profile and lesser incidence of post-operative nausea and vomiting and therefore considered  as a better technique in day care surgeries.Propofol (2, 6-disopropylphenol) is a short-acting intravenous anaesthetic agent that is widely used for total intravenous anaesthesia (TIVA) to induce and maintain anaesthesia, as well as for sedation.Dexmedetomidine is an alpha-2 agonist having both sedative and analgesic property. Intravenous (IV) dexmedetomidine is effective as a primary sedative in adult patients undergoing a variety of diagnostic or surgical procedures requiring monitored anaesthesia care.Furthermore there are no Indian data available at present to describe about the effect of type of anaesthesia on CPSP after laparoscopic cholecystectomy.We therefore would like to compare  the incidence of CPSP after two different types of TIVA.The Primary objective is to find out the incidence of chronic post-operative surgical pain(CPSP) after laparoscopic cholecystectomy and the secondary objective is to compare the incidence of CPSP and recovery profile between two different types of   TIVA.

Patients will be randomised to receive either either fentanyl-propofol or fentanyl-dexmedetomidine to maintain Bispectral index around 40-50 and or to maintain hemodynamic variables within 20% of baseline after standard anaesthesia induction as per group allocation.

All patients will be operated by the same surgical team with the standard number of port placement and surgical steps.

All patients will receive injection ondansetron 0.1mg/kg IV and injection paracetamol 1g IV after deflation of gas. Infusion of study drug stopped before closure of last laparoscopic port. All the port sites will receive infiltration with 0.5% bupivacaine 5ml diluted to 10ml with normal saline. At the end of surgery residual neuromuscular blockade will be reversed with injection neostigmine 0.05-0.07mg/kg and injection glycopyrrolate 20mcg/kg IV.Time from administration of reversal agent to time to eye opening, time to achieve limb lift on command will be noted. After satisfying extubation criteria patient will be extubated and shifted to post anaesthesia care unit (PACU). Modified Aldrete score will be assessed every hourly until score>9 and it will be noted.

A fixed post-operative analgesic regimen will be standardized in the PACU. Pain will be assessed by NRS every 30 minutes and injection tramadol 100mg bolus IV will be administered on patients demand or when the NRS > 3 at rest in the postoperative period. This will be followed by injection tramadol 50mg IV every 8th hourly.

All patients will be visited 24 hrs post op in respective wards & will be asked about presence of nausea, vomiting& pain in non-leading manner. If the patient complains of pain injection fentanyl 1mcg/kg will be given IV followed by 0.5mcg/kg IV after 20 minutes till NRS<3 at rest and NRS<4 during cough. The number of rescue analgesics,total amount of fentanyl consumption and maximum pain score by NRS will be noted.

Before discharge from the hospital patients will be informed of the long term pain they might continue to experience at the end of two and four months. Each patient will be interviewed over telephone by an investigator at 1st, 2nd, 3rd, 4th month after the surgery. Patients will be  asked questions about pain intensity at daily life activity, location of the pain, characteristics of the pain[allodynia-like pain (pain owing to a stimulus that does not normally provoke pain; such as gentle touching of the skin by hand or clothing), burningpain, pain in response to cold, lacerating pain, a ‘pins and needles’ sensation, and aches.],duration of the pain and use of analgesic drugs. If pain is present at the time of interview, the patient will be asked to rate the intensity of the pain during the most recent 7 days at daily life activity using an NRS.

 
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