| CTRI Number |
CTRI/2018/02/012083 [Registered on: 22/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
single blind,randomized,prospective |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two Adjuvant Drugs With Local Anaesthetic Drug in blocking nerve supply for upper limb surgeries |
|
Scientific Title of Study
|
comparison of efficacy of adding dexmetedomine versus fentanyl to bupivacaine in brachial plexus block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDeep Shikha |
| Designation |
second year resident doctor anaesthesiology |
| Affiliation |
BJ medical college |
| Address |
New PG Hostel,phase 2,room no-E306,civil hospital campus,Asarwa.Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
7405848568 |
| Fax |
|
| Email |
stunningshikha87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Patel |
| Designation |
asst. professor |
| Affiliation |
B J Medical College, |
| Address |
Dept. of Anaesthesiology, B J Medical College, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Patel |
| Designation |
asst. professor |
| Affiliation |
B J Medical College, |
| Address |
Dept. of Anaesthesiology, B J Medical College, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Health and Family Welfare Department.Government of Gujarat,7th Floor, 7th Block, New Sachivalay, Gandhinagar |
|
|
Primary Sponsor
|
| Name |
Department of Health and Family Welfare |
| Address |
7th Floor, 7th Block, New Sachivalay, Gandhinagar. |
| Type of Sponsor |
Government 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 |
| DEEPSHIKHA |
Orthopaedic Operation Theatre |
F-1 Wing, Civil Hospital, Asarwa, Ahmedabad-380016
Ahmadabad
GUJARAT |
7405848568
stunningshikha87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,b.j medical college & civil hospital,ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grading I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
brachial plexus block |
under ultrasonographic guidance using stimuplex needle. |
| Comparator Agent |
dexmetedomine,fentanyl |
comparison in terms of onset,duration of action & post operative analgesia and sedation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II
SCHEDULED FOR UPPER LIMB SURGERIES |
|
| ExclusionCriteria |
| Details |
patient refusal
patients with history of cardiac,respiratory,renal or hepatic failure
coagulation disorder
local infection at the site of block
psychological disorders
allergy to study medications
chronic use of pain medication
patient with h/o substance abuse & current opiod use |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of post-operative analgesia |
duration of post-operative analgesia 24 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to observe onset and duration of sensory and motor effect,peri-operative hemodynamic changes and any complications. |
intra-operative and 24 hrs post-operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2018 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study patient who will be fulfilling the inclusion criteria will be assesed preoperatively and all investigation will be noted. on the day of surgery procedure will be explained to the patient and conset will be taken. peri operative vitals will be noted. all patient would be premedicated with ondensetron (0.15 mg/kg) 15-30 min prior to block. following skin preparation brachial plexus block will be performed under ultrasonographic technique using stimuplex needle after negative aspiration of air and blood, drug will be injected & proper spread of drug around plexus is continuosly evaluated. brachial plexus block will be performed on group BD (n=30) with 35 ml 0.375% bupivacaine +50 microgram dexmetedomine(1mcg/kg) while group BF (n=30) would receive block with 35ml 0.375% bupivacaine and fentanyl 75 microgram (1.5 mcg). ONSET OF SENSORY BLOCK- it will be time taken from the end of injection to the first no response to pinprick in the distribution of any three sensory nerve in hand sensory score 0 normal sensation to pin prick 1 dull sensation to pin prick 2 no sensation to pin prick ONSET OF MOTOR BLOCK-it will be time from injection until onset of complete loss of motor power motor score 0 normal motor function with full flexion and extension elbow,wrist and finger 1 decreased motor strength with ability to move fingers only 2 complete motor blockade with inablity to move fingers Duration of sensory block (the time taken between onset of sensory block and appearance of pain requiring analgesia ) Duration of motor block (time taken between onset of motor block to complete return of motor power) will be recorded. pain will be assessed using Visual Analog Scale (VAS) where 0=no pain and 10=worst imaginable pain . good pain relief is defined as VAS<4 ,once this score is reached ,rescue analgesic inj Tramadol (1.5mg/kg) iv will be given. in post operative period heart rate, blood pressure ,VAS, Ramsay sedation score,time taken for first rescue analgesic will be recorded at 2,6,12,18,24 hrs postoperatively |