| CTRI Number |
CTRI/2020/02/023104 [Registered on: 04/02/2020] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
PSOAS COMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCK AS AN ANAESTHETIC TECHNIQUE FOR LOWER LIMB ORTHOPAEDIC SURGERY |
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Scientific Title of Study
|
COMBINED PSOAS COMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCK AS A SOLE ANAESTHETIC TECHNIQUE FOR LOWER LIMB ORTHOPAEDIC SURGERY |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita patel |
| Designation |
Second year resident |
| Affiliation |
Ssgh baroda |
| Address |
Room no. 26
New pg2 hostel
Department of anaesthesia
Ssg hospital
Baroda
Vadodara GUJARAT 390001 India |
| Phone |
7698153071 |
| Fax |
|
| Email |
dhyanesh75@outlook.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr kavita lalchandani |
| Designation |
Associate professor |
| Affiliation |
Ssgh baroda |
| Address |
Department of anesthesiology
2nd floor
New surgical block
Ssg hospital
Baroda.
Vadodara GUJARAT 390001 India |
| Phone |
9274586809 |
| Fax |
|
| Email |
Lalchandanikavita@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr kavita lalchandani |
| Designation |
Associate professor |
| Affiliation |
Ssgh baroda |
| Address |
Department of anesthesiology
2nd floor
New surgical block
Ssg hospital
Baroda.
Vadodara GUJARAT 390001 India |
| Phone |
9274586809 |
| Fax |
|
| Email |
Lalchandanikavita@yahoo.in |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
ssg hospital |
| Address |
SSG HOSPITAL, GOVERNMENT MEDICAL COLLEGE, BARODA |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ankita Patel |
Ssg hospital |
Department of anaesthesiology
New surgical block
ssg hospital sayajigunj
baroda medical college
vadodara Vadodara GUJARAT |
7698153071
dhyanesh75@outlook.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee for human research(IECHR)-POSTGRADUATES |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Peripheral nerve stimulator guided block |
In this study we are comparing psoas compartment block and sciatic nerve block in case of onset and effect of motor and sensory block and duration of analgesia versus unilateral spinal anaesthesia. |
| Intervention |
Unilateral spinal anaesthesia |
COMBINED PSOAS COMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCK AS A SOLE ANAESTHETIC TECHNIQUEBFOR LOWER LIMB ORTHOPEDIC SURGERY |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
18 to 70 years of age
either sex
asa grading I II III
patient with planned lower limb orthopedic surgery
patient able to understand VAS score |
|
| ExclusionCriteria |
| Details |
patient not willing
allergy to local anaesthetic
contraindivcation of spinal anaesthesia
patirnt with coagulopathy neurological deficit local infection and significant history of alcohol or drug abuse, psychiatric illness
bilateral lower limb surgery,
patient with pelvic fracture |
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
Duration of analgesia(in hours)
|
duration of analgesia in case of psoas compartment block and sciatic nerve block versus spinal anaesthesia will be assessed upto 24 hours postoperatively |
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Secondary Outcome
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| Outcome |
TimePoints |
Onset time, peak effect, duration of sensory block
Onset time, peak effect and duration of motor block
Vital parameter
|
Onset time peak effect and duration of sensory block(in minutes)
Onset time peak effect and duration of motor block (in minutes)
Vital parameter for 2 hr
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Target Sample Size
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Total Sample Size="96" Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
07/02/2020 |
| 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 |
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Publication Details
|
Nil |
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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
|
COMBINED PSOAS
COMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCK
AS A SOLE ANAESTHETIC TECHNIQUE FOR LOWER LIMB ORTHOPAEDIC SURGERY – A PROSPECTIVE
RANDOMISED CONTROLLED STUDY PURPOSE - Our purpose of the study is to compare the quality of anaesthesia
and hemodynamic changes of combined psoas compartment block and sciatic nerve
block as a sole anaesthetic technique with that of unilateral subarachnoid
block for patients undergoing lower limb orthopaedic surgeries. AIM-The aims of the study are :To compare combined psoas compartment and sciatic
nerve block with subarachnoid block in terms of following parameters 1.Sensory block :
·
Onset
time
·
Peak
effect
·
Duration
of sensory block
2. Motor
block :
·
Onset
time
·
Peak
effect
·
Duration
of motor block
3.Vital
parameters:
4. Peri-operative
complication
5. Duration
of analgesia
6. Number of
rescue analgesic required within 24 hrs Group(P): (n=48)
In this group patients will be
given combined psoas compartment block and sciatic nerve block.
Group(S)
: (n=48)
In this group patients will be given unilateral subarachnoid
block. Psoas compartment block :
·
The block will be given in lateral
position. Surgical side leg will be in the nondependent position. ·
Two points will be marked – posterior
superior iliac spine (PSIS) and Intercristal line. ·
Line
will be drawn from the PSIS parallel to the spine and another line is
intercristal line. ·
Point
of intersection of the two lines is the point of needle insertion. ·
Under
all aseptic precaution 100mm 22 gauze insulated needle connected to nerve
locator set at 3mA frequency will be inserted at this point. When the needle
enters in the psoas compartment quadriceps motor response will be seen. Adequate
proximity to the nerves will be assured by continued twitching after reducing
the stimulation to 0.5mA. After negative aspiration 25ml local anaesthetic
solution will be injected.
Sciatic
nerve block:
·
The sciatic nerve block will be
performed by classical Labat’s approach. The patient with same lateral
decubitus position (Sim’s position)
·
Two lines will be drawn: the first
from the greater trochanter to the sacral hiatus and second from greater
trochanter to the posterosuperior iliac spine (PSIS). A perpendicular will be
drawn from the midpoint of the greater trochanter‑PSIS line, caudad that
intersected the greater trochanter‑sacral hiatus line, which represent the
insertion point.
·
Under all aseptic measures the
insulated needle will be connected to nerve stimulator set at 3 mA, and will be
inserted at right angles to the skin to elicit a motor response like planter
flexion. Adequate
proximity to the nerves will be assured by continue twitching after reducing
the stimulation to 0.5mA.
·
After
negative aspiration 25ml local anaesthetic solution will be injected.
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1 min
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2 min
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3
min
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5
min
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10 min
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15 min
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20 min
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25
min
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30 min
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sensory
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Onset
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Peak effect
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motor
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Onset
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Peak effect
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v Post-operative
Monitoring of Patient:
Effect of Sensory block and
post-operative analgesia (Visual Analogue Score – VAS) will be assessed every
1hr for first 6 hours, every 2 hour for next 6 hours and then at 18 and 24
hours.
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1hr
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2hr
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3hr
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4hr
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5hr
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6hr
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8hr
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10hr
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12hr
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18 hr
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24 hr
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Sensory block
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Motor block
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Analgesia
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