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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 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   PSOAS COMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCK AS AN ANAESTHETIC TECHNIQUE FOR LOWER LIMB ORTHOPAEDIC SURGERY 
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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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  
 
Source of Monetary or Material Support  
No material support 
 
Primary Sponsor  
Name  ssg hospital 
Address  SSG HOSPITAL, GOVERNMENT MEDICAL COLLEGE, BARODA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee for human research(IECHR)-POSTGRADUATES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
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 
 
Inclusion Criteria  
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 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
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 
 
Secondary Outcome  
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

 
 
Target Sample Size   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" 
Phase of Trial   N/A 
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 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 

 

 

1 min

2 min

3  min

5  min

10 min

15 min

20 min

25

min

30 min

sensory

Onset

 

 

 

 

 

 

 

 

 

 

Peak effect

 

 

 

 

 

 

 

 

 

motor

Onset

 

 

 

 

 

 

 

 

 

 

Peak effect

 

 

 

 

 

 

 

 

 

 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.

 

1hr

2hr

3hr

4hr

5hr

6hr

8hr

10hr

12hr

18 hr

24 hr

Sensory block

 

 

 

 

 

 

 

 

 

 

 

Motor block

 

 

 

 

 

 

 

 

 

 

 

Analgesia

 

 

 

 

 

 

 

 

 

 

 

 


 
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