| 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
|
|
|
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
|
|
|
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) |