FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/03/012524 [Registered on: 13/03/2018] Trial Registered Prospectively
Last Modified On: 11/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Post operative pain relief for skin grafting site pain 
Scientific Title of Study   Fascia Iliaca Compartment Block (FICB) for skin donor site pain: Comparative study of 50 patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramneesh Garg 
Designation  Associate Professor 
Affiliation  DMC&H 
Address  Dept of Plastic Surgery
Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9501035555  
Fax    
Email  ramneeshgarg@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramneesh Garg 
Designation  Associate Professor 
Affiliation  DMC&H 
Address  Dept of Plastic Surgery
Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9501035555  
Fax    
Email  ramneeshgarg@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramneesh Garg 
Designation  Associate Professor 
Affiliation  DMC&H 
Address  Dept of Plastic Surgery
Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9501035555  
Fax    
Email  ramneeshgarg@yahoo.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Tagore Nagar Ludhiana 
 
Primary Sponsor  
Name  DMC 
Address  Tagore Nagar Ludhiana 
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 Ramneesh Garg  Dayanand Medical College & Hospital  Asso Professor Dept of Plastic Surgery Tagore Nagar Ludhiana
Ludhiana
PUNJAB 
9501035555

ramneeshgarg@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHEICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients coming for skin grafting,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine  0.8ml/Kg body weight of 0.25% bupivacine bolus in FICB catheter Then continous infusion of 0.125% bupivacine at the rate of 10ml/hour for next 72 hours through FICB catheter  
Intervention  Normal saline  0.8ml/Kg body weight of 0.9% normal saline bolus in FICB catheter. Then continuous infusion of 0.9% normal saline at the rate of 10ml/hour for next 72 hours through FICB catheter  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in whom skin graft is taken from lateral or anterior part of one thigh only
 
 
ExclusionCriteria 
Details  Patients refusal
Anticoagulation
Previous femoral bypass surgery
Inflammation / infection at the site of injection
Allergy to any drugs which will be used
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain releif  Post operative pain releif 
 
Secondary Outcome  
Outcome  TimePoints 
Patients pain relief satisfaction score will be recorded  1 hour after the FICB infusion is stopped 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   02/04/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background 

Thigh is the commonest site for harvesting the skin graft. Almost all patients have varying degree of pain for 3 to 4 days after the procedure. In some patients pain persists even after giving oral analgesics which hamper their routine activities

Aims 

To compare skin graft donor site pain relief using continuous FICB with 0.125% bupivacaine with those who will receive a placebo infusion of 0.9% normal saline. Patient satisfaction score at the end of study will also be noted

Methods 

IEC clearance will be taken. Informed written consent from patients will be obtained. Standardized SA technique using 2ml of 0.5% bupivacine will be used in all patients. Patients will be randomly assigned to the FICB or placebo block groups of 25 each. 

After giving SA, under all aseptic precautions, using landmark guided Fascia iliaca compartment catheter will be introduced on the thigh from which skin graft is to be taken, catheter will be fixed and surgery will be allowed .

In the postoperative period, as soon as patient complains of pain more than VAS 4, they will be given the intervention drugs according to the group to which that patient belongs as follows:

In Group I, patient will be given 0.8ml/Kg body weight of 0.25% bupivacine bolus in FICB catheter followed by a continuous infusion of 0.125% bupivacine at the rate of 10ml/hour for next 72 hours through FICB catheter.

In Group II,  patient will be given 0.8ml/Kg body weight of 0.9% normal saline bolus in FICB catheter followed by a continuous infusion of 0.9 of normal saline at the rate of 10ml/hour for next 72 hours through FICB catheter. 

Postoperative pain will be assessed using VAS at  2 h, 4 h, 6 h, 12 h, 24 h, 36h, 48 h, 60h and 72h after FICB continuous infusion is started. 

Any patient complaining VAS greater than or equal to 4 or at any point of time or when patient complains of pain will be administered rescue analgesic in the form of intravenous injection Tramadol 50 mg and time of first rescue analgesic request will be noted. If the patient still reports VAS greater than 4 after 30 minutes of receiving Tramadol, similar dose will be repeated up to a maximum of 100 mg in contiguous 4 hours or 400 mg in 24 hours. any patient complaining of pain even after giving injection Tramadol according to the protocol, will be given second rescue analgesic  of injection diclofenac sodium 75mg diluted in 10 ml saline, slow intravenously over 5 minutes and will not be repeated earlier than 8 hours of first injection with a total of three injections in 24 hours. Total doses of first and second rescue analgesic consumed in 72 hours after continuous infusion analgesia is started will also be recorded.

FICB catheter will be removed 72 hours after analgesic infusion is started and study period will end. Any pain persisting 72 hours after analgesia is started will be treated as per department protocol. Patients pain relief satisfaction score will be recorded 1 hour after the FICB infusion is stopped as:

Excellent (4), Good (3), Moderate (2), Poor (1)


 
Close