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CTRI Number  CTRI/2021/03/032013 [Registered on: 15/03/2021] Trial Registered Prospectively
Last Modified On: 06/03/2021
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   A PERIPFERAL NERVE STIMULATOR GUIDED POPLITEAL SCIATIC NERVE BLOCK COMBINED WITH ADDUCTOR CANAL BLOCK IN LOWER LEG SURGERY. 
Scientific Title of Study   A PERIPFERAL NERVE STIMULATOR GUIDED POPLITEAL SCIATIC NERVE BLOCK COMBINED WITH ADDUCTOR CANAL BLOCK IN LOWER LEG SURGERY-AS A SOLE ANESTHETIC TECHNIQUE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDarshit Chauhan 
Designation  PG Student 
Affiliation  SSG Hospital,Vadodara. 
Address  SSG hospital & Medical College, Kala ghoda circal, sayajigunj, Vadodara-390001

Rajkot
GUJARAT
390001
India 
Phone  9033734634  
Fax    
Email  chauhandarshit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Shah 
Designation  Assistent Professor 
Affiliation  SSG Hospital,Vadodara. 
Address  Department of Anaesthesiology, SSG Hospital, Near Kalaghoda Circle, Sayajigunj, Vadodara.

Vadodara
GUJARAT
390001
India 
Phone    
Fax    
Email  nehakinit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Darshit Chauhan 
Designation  PG Student 
Affiliation  SSG Hospital,Vadodara. 
Address  Department of Anaesthesiology, SSG Hospital, Near Kalaghoda Circle, Sayajigunj, Vadodara.

Rajkot
GUJARAT
360006
India 
Phone  09033734634  
Fax    
Email  chauhandarshit@gmail.com  
 
Source of Monetary or Material Support  
SSG Hospital, Sayajigunj, Vadodara 
 
Primary Sponsor  
Name  SSG HospitalVadodara 
Address  SSG Hospital, Sayajigunj, Vadodara 
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 
Dr Darshit Chauhan  SSG Hospital  Department of Anesthesiology, SSG Hospital, Near Kalaghoda Circal, Sayajigunj, Vadodara.
Vadodara
GUJARAT 
09033734634

chauhandarshit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research(IECHR)-Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S999||Unspecified injury of ankle and foot,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COMBINED POPLITEAL SCIATIC NERVE BLOCK AND ADDUCTOR CANAL BLOCK  Patients will be given Popliteal Sciatic Block + Adductor Canal Block (Drug to be used:- 0.5% Bupivacaine 20 ml + 2% Lignocaine 20ml with 5mcg/ml 1:200000 Adrenaline and Sodabicarbonate 2ml) 
Comparator Agent  Unilateral Spinal Anaesthesia  Patients will be given Unilateral Spinal Anesthesia with Inj. Bupivacaine Heavy 0.5% 1ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Age Group – 18-70years of either sex.
2 Weight: Average 50 kg
3 ASA – I/II/III.
4 Malampatti Grade- I / II
5 Duration of Surgery Less than 2 hrs.
6 Patient posted for lower leg surgeries (e.g. orthopedic surgeries: foot, ankle, distal tibia; PVD surgeries: tarsal and metatarsal amputations and debridement etc.)
7 Patient able to give written & informed consent.
8 Patient able to understand VAS regarding assessment of pain.
 
 
ExclusionCriteria 
Details  1 Patient not willing for procedure.
2 Patients with coagulopathy, local infection, pre- existing neuropathy, head injury.
3 Patient having contraindication for spinal anesthesia.
4 Hypersensitivity to local anesthetic drug.
5 Patients with significant h/o drug or alcohol abuse, psychiatric illness
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Onset and Duration of Sensory and Motor block
2 Evaluation of block for satisfactory anesthesia
3 Vital Parameters
4 Total duration of analgesia
 
Patient will be Monitored for above mantion Parameters immediately after block,at 5 minute interval for first 10 min,at 10 minute interval for 1 hour and at 20 minute interval for next 1 hour. 
 
Secondary Outcome  
Outcome  TimePoints 
•Perioperative complications
 
Patient will be monitored postoperatively for 24 hour. 
 
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)   01/04/2021 
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)?  

Response - NO
Brief Summary  

The study will be a type of prospective randomised controlled trial undertaken in adult patients of 18 to 70 year of age admitted in SSG hospital requiring lower leg surgery with a sample size of 60 patients.

Pre-operative Preparation:

• Patient to be kept nil by mouth(NBM) for minimum 6-8 Hours.

• Patient will be explained about VAS score preoperatively.

• Operation theatre preparation for all necessary equipments and drugs to be kept ready.

• Anesthesia machine with monitor to be kept ready.

• IV line will be taken with 18G cannula.

Premedication:-

ON THE DAY BEFORE SURGERY

Tab Ranitidine 150  mg PO 1 HS

ON THE DAY OF SURGERY

5 Minutes before induction:

Inj. Glycopyrrolate 0.2 mg IV

Inj. Ondansetron 4 mg IV

 

Anesthesia method:

INDUCTION OF ANAESTHESIA:

The patients will be randomly allocated into two groups by sealed envelope method.

Grouping of Patients:

• Group P(N=30)

Patients will be given Popliteal Sciatic Block  + Adductor Canal Block (Drug to be used:- 0.5% Bupivacaine  20 ml + 2% Lignocaine 20ml with 5mcg/ml 1:200000 Adrenaline and Sodabicarbonate 2ml)

• Group S(N=30)

Patients will be given Unilateral Spinal Anesthesia with Inj. Bupivacaine Heavy 0.5% 1ml.

Ø  Injection Midazolam 1mg/kg will be given in all the patients after procedure.

 

Technique For Popliteal Sciatic Block:-

Position: Supine with Hip Flexed at 30* by putting pillow below the heel and Knee Fully Extended.

The landmark for needle insertion is approximately 10cm above the Most Prominent part of Lateral Femoral Condyle in the groove between Biceps Femoris  and the vastus Lateralis muscle.

 

Nerve Locator Technique: In proposed study we will use this technique.

• A22-gauge 8-inch insulated needle is attached to the negative electrode of the PNS. The extension tubing is primed and attached to a syringe filled with local anesthetic solution.

•The initial current strength is set at 3mA with 2Hz frequency and 0.1ms duration.

• The needle is inserted in the groove between the Biceps Femoris and Vastus lateralis by palpating it with finger tips and is directed perpendicular to the skin till the Planter Flexion of Foot is elicited.

• Amplitude to be decreased up to 0.5 mA while seeking maximal Planter Flexion contraction. If necessary needle should be relocated to achieve adequate contraction while reducing amplitude. If there is continued Planter Flexion contraction when at 0.2 mA or less withdraw needle. Stimulation at this low level may indicate intraneural placement of the needle.

• After the injection of 1 ml of local anesthetic the contractions should start to fade.

• Always aspiration should be done before injection, during injection and after injection to ensure that inadvertent intravascular injection has not occurred. If the aspiration for blood is negative, 21ml local anesthetic is injected.

• If the patient experiences excruciating pain or parasthesia with injection withdraw the needle slightly.

• Complete effect of the block will be achieved in 20 minutes.

Technique For Adductor Canal Block

Position: Supine. A pillow will be placed under the knee and thigh.

The landmark for needle insertion is approximately 4 finger breadth (7 -8 cm) above the adductor tubercle on the medical condyle of the femur in the groove between Sartorius and the vastus medialis muscle

The groove is also known as the Jobert’s fossa.

 

Nerve Locator Technique: In proposed study we will use this technique.

• A22-gauge 8-inch insulated needle is attached to the negative electrode of the PNS. The extension tubing is primed and attached to a syringe filled with LA solution.

•The initial current strength is set at 3mA with 2Hz frequency and 0.1ms duration.

•The block is best done by standing on the opposite side to the block site.

• The needle is inserted in the groove between the vastus medialis and Sartorius by palpating it with finger tips and is directed perpendicular to the skin with slight posterior angulation till the contraction of vastus medialis muscle is elicited.

• Amplitude to be decreased up to 0.5 mA while seeking maximal vastus medialis contraction. If contractions are fading while reducing amplitude, needle should be relocated to achieve adequate contraction.  If there is continued vastus medialis contraction when at 0.2 mA or less withdraw needle. Stimulation at this low level may indicate intraneural placement of the needle.

• After the injection of 1 ml of local anesthetic the contractions should start to fade.

• Always aspiration should be done before injection, during injection and after injection to ensure that inadvertent intravascular injection has not occurred. If the aspiration for blood is negative, 21ml local anesthetic is injected.

• If the patient experiences excruciating pain or paresthesia with injection withdraw the needle slightly.

• Complete effect of the block will be achieved in 20 minutes.

 

Technique For Unilateral Spinal anesthesia

Position: Lateral (Operative site to be in lower side)

                Under all aseptic and antiseptic precaution spinal anesthesia should be given in L3-L4 space with 23G spinal needle with injection 0.5% Bupivacaine Heavy 1ml. Patient kept in lateral position for 10 minutes.

 
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