| CTRI Number |
CTRI/2018/08/015389 [Registered on: 20/08/2018] Trial Registered Prospectively |
| Last Modified On: |
16/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Dexmedetomidine by two different routes with bupivacaine in ultrasound guided block for upper limb surgeries. |
|
Scientific Title of Study
|
A comparative study of dexmedetomidine by two different routes as an adjunct to bupivacaine in usg guided supraclavicular block for upper limb surgeries-
A prospective randomized placebo controlled triple blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishchint Sharma |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC kangra at Tanda |
| Address |
Department of Anesthesia, Dr. Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.)
Kangra HIMACHAL PRADESH 176001 India |
| Phone |
8894111107 |
| Fax |
|
| Email |
nishchintsharma321@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shyam Bhandari |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.) |
| Address |
Department of Anesthesia , Dr Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.)
Kangra HIMACHAL PRADESH 176001 India |
| Phone |
9805098588 |
| Fax |
|
| Email |
dr.bhandari@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shyam Bhandari |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.) |
| Address |
Department of Anesthesia , Dr Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.)
Chamba HIMACHAL PRADESH 176001 India |
| Phone |
9805098588 |
| Fax |
|
| Email |
dr.bhandari@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Dr RPGMC, Kangra at Tanda- 176001 (H.P.) |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda |
| Address |
Department of Anesthesia, Dr. Rajendra Prasad Govt. Medical College, Kangra at Tanda (H.P.) |
| 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 |
| Dr Nishchint Sharma |
Dr Rajendra Prasad Govt. Medical College |
OT-1 & 2,Department of Anesthesia
Kangra HIMACHAL PRADESH |
8894111107
nishchintsharma321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC, Kangra at Tanda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing Elective Surgeries in Supraclavicular Block , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brachial Block |
Ultasound Guided Supraclavicular Block |
| Comparator Agent |
Bupivacaine |
20 ml of 0.5% Bupivacaine + 1ml Normal Saline
and 1ml Normal Saline intramuscular
|
| Comparator Agent |
Dexmedetomidine |
20ml of 0.5% Bupivacaine + 50µg Dexmedetomidine in 1ml Normal Saline and 1ml Normal Saline intramuscular. |
| Comparator Agent |
Dexmedetomidine IM |
20ml of 0.5% Bupivacaine + 1ml Normal saline and 1µg/kg Dexmedetomidine intramuscular |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA class I-II
2. BMI 18.5-29.9
3. Undergoing surgeries around midarm, elbow, forearm and hand |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal for block
2. History of cardiac, renal or hepatic disease, CNS disorders,neuropathy
3. Patients having bleeding disorders
4. Hypersensitivity to local anesthetics
5. Local infection at the site where needle for block is to be inserted
6. Patients noted to have dysrhythmias on the electrocardiogram (ECG)
7. Allergic to study drugs
8. Patients in whom the block effect will be partial and will require supplementary anesthesia
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the onset and duration of sensory and motor blockade with two different routes of dexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacaine in ultrasound guided supraclavicular brachial plexus block in patients scheduled for upper limb orthopaedic surgeries |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study and compare sedation with different routes of dexmedetomidine |
24 HOURS |
| • To study and compare the hemodynamic stability of two different routes of dexmedetomidine. |
24 HOURS |
| To observe for side effects of dexmedetomidine in two different routes, if any. |
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/09/2018 |
| 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="1" 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
|
The purpose of this study is to compare the onset and
duration of sensory and motor blockade with two different routes of
dexmedetomidine viz. perineural and intramuscular as an adjuvant to 0.5% bupivacaine
in ultrasound guided supraclavicular brachial plexus block. The
study will be conducted for a period of 12 months. It will be a prospective,
triple blind placebo control trial study. The patients will be allocated one of
the three groups by block randomization. The study drug solution will be prepared
by anesthesiologist not involved in the study. The anesthesiologist performing
the block and anesthesiologist observing the patient, both will be blinded to
the study groups. Data will be analyzed by the anesthesiologist who will be
unaware of the group allocation.
The enrolled patients after fulfilling all the
inclusion and exclusion criteria will be divided into 3 groups.(i) Group B (n=30) Control Group –20 ml of 0.5%
Bupivacaine +1ml Normal Saline and 1ml Normal Saline intramuscular.(ii) Group BD (n=30) Dexmedetomidine Group–20 ml of 0.5% Bupivacaine + 50µg Dexmedetomidine in 1ml Normal Saline and 1ml Normal Saline
intramuscular.(iii)Group BDIM (n=30) Dexmedetomidine IM Group –20 ml of 0.5% Bupivacaine + 1ml Normal saline and 1µg/kg Dexmedetomidine intramuscular.(A total volume of 21ml will be
given in brachial plexus block)
Sensory and motor blockade will be assessed in
territories of three nerves (radial, ulnar and median) for every 3 min after completion of injection
till 30 minutes and then for every 30 minutes after the end of surgery till the
first 12 h, thereafter hourly until the block will have completely worn off.Sensory
block (three nerve territories) will be assessed by pin prick test using a
3-point scale: 0 = normal sensation, 1 = loss of sensation of pin prick
(analgesia), and2 = loss of sensation of touch (anesthesia) on dorsum of hand
around anatomical snuff box for radial nerve, on hypothenar eminence for ulnar
nerve, on medial side of thenar eminence for median nerve. Motor block will be determined by thumb
abduction (radial nerve), thumb adduction (ulnar nerve), thumb opposition
(median nerve). Further block assessment will be done at hourly intervals up to
24 hours by a blinded anesthesiologist.
The primary outcome measure in this study will be
the time to first analgesic request.
The secondary
outcome measures include the number of supplemental analgesic requirements, VAS
pain, nausea, patient satisfaction and onset and duration of sensory block and
motor block episode of hypotension and bradycardia. |