| CTRI Number |
CTRI/2015/06/005866 [Registered on: 04/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
use of midazolam with lignocaine for nerve block in forearm and hand surgeries for postoperative pain relief |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF MIDAZOLAM IN TWO DIFFERENT DOSES AS AN ADJUNCT TO LIGNOCAINE FOR ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK
A RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sood |
| Designation |
post graduate student, anaesthesiology |
| Affiliation |
DR RPGMC Tanda at Kangra |
| Address |
Department of anaesthesia,
Dr RPGMC Tanda at Kangra
Himachal Pradesh
PIN 176001
Junior Resident
Department of anaesthesia, Dr RPGMC Tanda at Kangra
Himachal Pradesh
PIN 176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418397653 |
| Fax |
|
| Email |
s06.priyanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Versha Verma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical College |
| Address |
Department of Anaesthesia
Department of Anesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra
Kangra
HIMACHAL PRADESH
176001
Department of Anesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra
Kangra
HIMACHAL PRADESH
176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
09418152286 |
| Fax |
|
| Email |
versha2u@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Versha Verma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Government Medical College |
| Address |
Department of Anaesthesia
Department of Anesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra
Kangra
HIMACHAL PRADESH
176001
Department of Anaesthesia
Department of Anesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra
Kangra
HIMACHAL PRADESH
176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
09418152286 |
| Fax |
|
| Email |
versha2u@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Government Medical College |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
Department of Anesthesia
Dr Rajendra Prasad Government Medical College Tanda Kangra
Kangra
HIMACHAL PRADESH
176001 |
| 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 Versha Verma |
OT Complex, Department of Anesthesia Dr Rajendra Prasad Government Medical College |
Orthopaedic OT 1 and 2
OT complex 2nd floor
Department of Anesthesia
Dr Rajendra Prasad Government Medical College
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418152286
01892-267115
versha2u@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra Prasad Government Medical College & Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing orthopaedic upper extremity surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
midazolam |
to observe the effect of midazolam in two doses 30 microgram/kg and 50 microgram/kg as an adjunct to lignocaine 1.5% with adrenaline (1:200000) in ultrasound guided supraclavicular brachial plexus block |
| Intervention |
midazolam in ultrasound guided supraclavicular brachial plexus block |
Group L(control): 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 5 ml of Normal saline;
Group M30 : 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + midazolam 30 microgram/kg + Normal saline ;
Group M50 : 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 50 microgram/kg midazolam + Normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females between the age group 18-60 years.
2. ASA class I-II.
3. BMI 18.5-29.9.
4. Undergoing surgeries around elbow, forearm and hand.
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal for block.
2.Patients having bleeding disorders.
3.Local infection at the site where needle for block is to be inserted.
4.Allergic to study drugs.
5.Patients of head injury, renal disease, liver disease and cardiac disease.
6.Patients in whom the block effect will be partial and will require supplementary anesthesia
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To study and compare the duration of analgesia in three group of patients. |
duration of analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To evaluate and compare the onset and duration of sensory and motor blockade with lignocaine with adrenaline (1: 200000) alone and with midazolam in two different doses.
•To find the optimal dose of midazolam as an adjunct for brachial plexus block and post-operative analgesia.
•To observe for side effects of midazolam, if any.
|
.onset and duration of sensory and motor block |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The present study was carried out on 90 patients, ASA I and II, aged between 18-60 years, scheduled for orthopedic upper extremity surgery under ultrasound guided supraclavicular brachial plexus block. The patients were randomly divided into three groups. Group L (n=30) received 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 5 ml of normal saline. Group M30 (n=30) received 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 30 µg/kg midazolam + normal saline (total volume 25 ml) and group M50 (n=30) received 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 50µg/kg midazolam + normal saline (total volume 25 ml). The block effect was studied in the three groups for the onset of sensory and motor block, duration of sensory and motor block and the total duration of post operative analgesia. Quality of block was evaluated as partial/failed blocks among the three groups and Surgeon’s satisfaction score. The patients were also closely examined for any hemodynamic changes, sedation score and total number of rescue analgesics required in 24 hours. |