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CTRI Number  CTRI/2016/02/006692 [Registered on: 29/02/2016] Trial Registered Prospectively
Last Modified On: 23/02/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of combination of drugs on pain relief in patients undergoing surgery for fracture of lower limb 
Scientific Title of Study   Efficacy of preemptive multimodal analgesia for post operative pain relief in trauma patients undergoing lower limb surgery-A Randomised trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeetinder kaur 
Designation  Additional Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH 
Address  Department of Anesthesia Nehru Hospital PGIMER
Sector 12, Chandigarh India
Chandigarh
CHANDIGARH
160012
India 
Phone  7087009510  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jeetinder kaur 
Designation  Additional Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH 
Address  Department of Anesthesia Nehru Hospital PGIMER
Sector 12, Chandigarh India

CHANDIGARH
160012
India 
Phone  7087009510  
Fax    
Email  jeet1516@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jeetinder kaur 
Designation  Additional Professor 
Affiliation  POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH 
Address  Department of Anesthesia Nehru Hospital PGIMER
Sector 12, Chandigarh India

CHANDIGARH
160012
India 
Phone  7087009510  
Fax    
Email  jeet1516@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education & Research, Sector 12, Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institute Of Medical Education Research 
Address  Sector 12, Chandigarh 
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 
Jeetinder kaur makkar  Advanced trauma centre  Post Operative recovery room, 3rd floor, Advanced trauma centre, Post Graduate institute of Medical Education and research, Sector 12
Chandigarh
CHANDIGARH 
7087009510

jeet1516@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA status I to II patients undergoing post traumatic long bone surgeries of femur and tibia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C  Will not receive any premedication 
Intervention  Group PE  This group will receive preemptive multimodal pharmacologic agents ;Intravenous diclofenac 75 mg, intravenous morphine 3mg, 1gm of intravenous acetaminophen and 75mg pregabalin per orally one hour before the start of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing post traumatic long bone surgeries of femur and tibia. 
 
ExclusionCriteria 
Details  History of associated head injury, blunt trauma abdomen or blunt trauma chest 2) allergy and contraindications to any of the medications being used 3) history of being on chronic pain medications (i.e. slow-release preparations of opioids) 4) rheumatoid arthritis 4)psychiatric disorder 5) a history of diabetes with impaired renal function 6) morbid obese 7) patients unable or unwilling to use patient-controlled epidural analgesia (PCEA). (8) prior use of the investigated medications (9) current use of anticoagulants or antiplatelet medication 
 
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 
Mean number of boluses of PCA or PCEA  At 24 and 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Mean VAS scores in post operative period
Postoperative nausea, vomiting, sedation scores  
30 min, 1 hr, 2 hrs, 4hrs, 8hrs, 12 and 24 hrs and on postoperative day 2. 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/03/2016 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Group PE will receive the following preemptive multimodal pharmacologic agents-,Intravenous diclofenac 75 mg, intravenous morphine 3mg, 1gm of intravenous acetaminophen and 75mg pregabalin per orally.

After assessing for eligibility, patients will be explained about the study protocol, the use of the PCA pump, numerical rating score (NRS) and written informed consent will be obtained. All patients will be explained to report pain intensity on a VAS score of 0-10 where 0= no pain and 10= worst possible pain. For descriptive purposes, pain score between 0-3 will be taken as mild pain, 4-7 as moderate pain, 7-9 as severe pain and 10 as intolerable pain.

One hour prior to surgery, the sealed envelope will be opened and the card inside will determine the group allocation. The drugs will be administered at least 1 hour before surgery by a blinded anesthesiologist who will not participate in post operative assessment.

After securing intravenous cannula and adequate hydration with Ringer lactate , spinal anesthesia would be initiated with 3ml of 0.5% hyperbaric bupivacaine. In case general anesthesia is required, standard institute protocol shall be followed. All patients will be managed intraoperatively with combined spinal epidural anesthesia or general anesthesia with the same perioperative departmental protocol. Type of surgery, duration of surgery, baseline haemoglobin, blood loss, no of hypotensive episodes, intraoperative blood transfusion, intraoperative use of opoids and NSAIDS will be noted. The attending anesthesiologist will not be involved in the patients’ evaluation post-operatively.

All patients will be connected to a patient-controlled epidural analgesia pump (PCEA Plus; Abbott, Chicago, IL, USA) or Patient controlled analgesia upon arrival in the post-anesthesia care unit.. The patients will be instructed to push the button of the PCEA system or PCA each time they felt pain. The patient-controlled analgesia will be set at a bolus of 5 ml of 0.2 % ropivacaine with 2μgm/ml of fentanyl with a lockout time of 30 min in or 2ml of 1mg/kg morphine  At any point of time, if patient complains of pain with NRS>3, morphine 3mg will be given as rescue analgesia and time recorded.. Postoperative NRS scores will be recorded when the patient is admitted to the trauma recovery room, after 30 min, 1 hr, 2 hrs, 4hrs, 8hrs, 12 and 24 hrs and on postoperative day 2. Postoperative nausea, vomiting, sedation scores will be assessed at arrival time, 6 hrs and 24 hrs. Any episodes of respiratory depression, apnea, hypoventilation, desaturation will be noted.

 
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