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CTRI Number  CTRI/2024/05/067541 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To determine the effectiveness combination of T12 paravertebral,lumbar plexus and sacral plexus blocks in hip surgeries. 
Scientific Title of Study   A prospective observational study to determine the effectiveness of USG and PNS guided combination of T12 paravertebral,lumbar plexus and sacral plexus blocks in high risk patients undergoing hip surgeries 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mithranmajan G 
Designation  Junior resident,Anaesthesia 
Affiliation  Government medical college,Surat 
Address  Department of Anaesthesia,2nd floor,Old college building,,Government medical college and New civil hospital Surat,Ring Road , Opp stem Cell Hospital,Khatodara Wadi,Majura Gate ,Surat,Gujarat

Surat
GUJARAT
395001
India 
Phone  9656436524  
Fax    
Email  mithranmajan1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bansari N Kantharia 
Designation  Additional Professor,Anaesthesia 
Affiliation  Government medical college,Surat 
Address  Department of Anaesthesia,2nd floor,Old college building,,Government medical college and New civil hospital Surat,Ring Road , Opp stem Cell Hospital,Khatodara Wadi,Majura Gate ,Surat,Gujarat

Surat
GUJARAT
395001
India 
Phone  9825690177  
Fax    
Email  bansarikantharia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bansari N Kantharia 
Designation  Additional Professor,Anaesthesia 
Affiliation  Government medical college,Surat 
Address  Department of Anaesthesia,2nd floor,Old college building,,Government medical college and New civil hospital Surat,Ring Road , Opp stem Cell Hospital,Khatodara Wadi,Majura Gate ,Surat,Gujarat

Surat
GUJARAT
395001
India 
Phone  9825690177  
Fax    
Email  bansarikantharia@yahoo.com  
 
Source of Monetary or Material Support  
Government medical college and New civil hospital surat 
 
Primary Sponsor  
Name  Government medical College and new civil hospital surat 
Address  Government medical College and new civil hospital surat,near majura gate 
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 Mithranmajan G  Government medical College and new civil hospital surat  Orthopaedic operation theatre,1st floor,Department of Anaesthesiology,Government medical College and new civil hospital surat,near majura gate surat Surat GUJARAT
Surat
GUJARAT 
9656436524

mithranmajan1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human research ethics committee GMC SURAT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients posted for hip orthopaedic surgeries
receiving T12 paravertebral block along with combined lumbar and sacral plexus.
Patients belonging to ASA grade 3/4
Patients giving written informed consent 
 
ExclusionCriteria 
Details  1.neuromuscular disease and established peripheral neuropathy 2.Skin infection at the site of needle insertion.
3.Chronic pain syndromes or receiving chronic analgesic therapy 4.Patients with reported history of allergy to any of the study drugs.
5.Patients having multiple fractures or having bilateral fractures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe ,
Time required to perform the block
Onset and duration of motor and sensory block
Quality of the block. 
To observe ,
Time required to perform the block
Sensory evaluation will be done by pin prick with a 23 G needle an interval of 5,10,15,20,25 and 30 minutes.

Motor block will be assessed at an interval of the 5, 10, 15, 20,
25 and 30 minutes. Motor block is graded on modified bromage scale

Quality of the block. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia & analgesic requirement in first 24hrs
Hemodynamic changes
Complications /adverse effect. 
At 2-hour, 4-hour, 8-hour, 12 hour & 24 hours after block.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/05/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Regional anesthesia is the most commonly used method of anesthesia for lower limb surgeries and the most common mode of regional anesthesia used is neuraxial anesthesia (spinal/epidural).
The benefits of using regional anesthesia in hip fracture surgeries as compared to the use of general anesthesia are significant reduction in the number of complications like the airway instrumentation and manipulation, venous thromboembolism, respiratory complications ,also has advantage of early resumption of oral intake postoperatively. Neuraxial anesthesia has several disadvantages like perioperative hemodynamic instability, urinary retention, epidural hematoma etc which can lead to undesirable events like myocardial infarction, stroke and CNS infection in high-risk surgical patients and patients on anticoagulant or antiplatelet medications which possess higher risk of postoperative morbidity and mortality.
Peripheral nerve blocks which block one or more Peripheral nerves that supply the surgical field in the operative limb are an effective method for lower limb surgeries.Newer techniques that is ultrasound-guided nerve blocks with nerve stimulator increase the success rate and reduce risks such as nerve injuries, hematomas and renal puncture.They also provide postoperative pain relief with improved patient satisfaction, stable hemodynamics, early ambulation thereby reducing the length of hospital stay.
The upper dermatome level of sensory block to T10 is recommended for hip surgery with spinal anesthesia. Recent studies show a dermatome level up to T12 may satisfy the requirement of surgical anesthesia for hip replacement. The nerves innervating the hip joints arise from the ventral rami of the spinal nerve roots of the lower part of the lumbar plexus (L2-4) and the upper part of the sacral plexus (L4-S1). The lateral femoral cutaneous nerve from the lumbar plexus (L2-L3), lateral cutaneous branch of iliohypogastric nerve (T12 and L1) and subcostal nerve (T12 thoracic nerve) innervate the area of the superior lateral gluteal region and the proximal lateral thigh that are involved in skin incision of posterolateral approach to hip joint .
Lumbar plexus block results in blockade of the femoral nerve, lateral femoral cutaneous nerve and the obturator nerve while the sacral plexus block results in blockade of the sciatic nerve, posterior cutaneous nerve of thigh, superior and inferior gluteal nerves, pudendal nerve, pelvic splanchnic nerve, inferior hypo- gastric plexus and the terminal portion of sympathetic trunk.
lumbar plexus and sacral plexus block do not provide enough sensory block in L1 and T12 dermatome which is required for consistent surgical anesthesia for hip surgery. To overcome this supplemental dosage of propofol and opioids, infiltration at incision and iliac crest point block are required. However, these techniques are not reliable, and conversion to general anesthesia is often required.
An ultrasound guided T12 Paravertebral block (PVB) provide sensory block of subcostal nerve and iliohypogastric nerve, it also blocks the superior gluteal cutaneous nerve derived from posterior branch of L1 and L2 spinal nerves through a paravertebral space spread.
This T12 PVB is safe, effective and simple, and will produce sensory blockade covering the surgical incision to the level above the great trochanter on the superior lateral gluteal region.
So far no study has done at our institution to determine the effectiveness of USG and PNS guided combination of these 3 blocks.So I would like to carry out this observational study.
 
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