FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076258 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 03/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A PROSPECTIVE STUDY TO COMPARE REAL TIME ULTRASOUND GUIDED SPINAL ANAESTHESIA VERSUS ULTRASOUND ASSISTED SPINAL ANAESTHESIA IN PATIENTS POSTED FOR TOTAL HIP REPLACEMENT SURGERY 
Scientific Title of Study   REAL TIME ULTRASOUND GUIDED VERSUS ULTRASOUND ASSISTED SPINAL ANAESTHESIA IN PATIENTS POSTED FOR TOTAL HIP REPLACEMENT SURGERY 
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 VIRENDRA KUMAR 
Designation  PROFESSOR JUNIOR GRADE 
Affiliation  Dr RML Institute of Medical Sciences, Lucknow 
Address  Department of Anaesthiology and Critical Care Medicine Dr RMLIMS Lucknow INDIA-226010

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007232  
Fax    
Email  virendrasankhwar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR VIRENDRA KUMAR 
Designation  PROFESSOR JUNIOR GRADE 
Affiliation  Dr RML Institute of Medical Sciences, Lucknow 
Address  Department of Anaesthiology and Critical Care Medicine Dr RMLIMS Lucknow INDIA-226010


UTTAR PRADESH
226010
India 
Phone  8176007232  
Fax    
Email  virendrasankhwar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR VIRENDRA KUMAR 
Designation  PROFESSOR JUNIOR GRADE 
Affiliation  Dr RML Institute of Medical Sciences, Lucknow 
Address  Department of Anaesthiology and Critical Care Medicine Dr RMLIMS Lucknow INDIA-226010


UTTAR PRADESH
226010
India 
Phone  8176007232  
Fax    
Email  virendrasankhwar@gmail.com  
 
Source of Monetary or Material Support  
DR RML IMS, LUCKNOW, 226010 
 
Primary Sponsor  
Name  DR VIRENDRA KUMAR 
Address  Department of Anaesthiology and Critical Care Medicine Dr RMLIMS Lucknow INDIA-226010 
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 MADHU  DEPARTMENT OF ANAESTHESIOLOGY Dr RAM MANOHAR LOHIYA ,IMS LUCKNOW  OPERATING ROOMS OF DR RML IMS LUCKNOW
Lucknow
UTTAR PRADESH 
8960328056

madhu.k9737@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  REAL TIME ULTRASOUND GUIDED SPINAL ANAESTHESIA AND ULTRASOUND GUIDED SPINAL ANAESTHESIA   USASgroup- where spinal anesthesia will be performed with ultrasound guided assistance. USRTG group- where spinal anesthesia will be performed with real time ultrasound guided. In the USAS group, spinal anesthesia with a paramedian approach will be performed based on the optimum puncture point, The probe will be placed for the parasagittal oblique (PSO)view and slide gently to obtain the optimal ultrasoundimage. Subsequently, the upper edge of the inferior laminar of the selected interlaminar space will moved to the center of the ultrasound screen. The midpoint of the probe will be considered as the optimum puncture point. The suggested puncture angles included the cephalad angle measure by the built-in angle program of the ultrasound and the medial angle measured by a 180°protractor(Deli).The puncture depth, the distance from the skin to the posterior complex,will be measured utilizing the ultrasound clipper tool. In the USRTG group, the systematic procedure will be performed according to the following steps. • Identification of the midline: the transducer will be placed on the spine in the transverse midline (TM)plane and slide gently until the acoustic shadow of the spinous processes was observed. The midpoint of the long axis of the transducer corresponded to the midline of the spine. • Identification of the laminar interspace: the probe will be placed for the PSO view, 1 to 2 cm lateral to the midline. A flat hyper echoic sacrum will be identified, and then the L5-S1 to L2-L3 laminar inter-spaces will be counted upwards. The level with the widest intervertebral space and the clearest anterior/posterior complex will be the first choice for puncture. • Skin marking: at the PSO view, the preferred inter laminar space will be move to the center of the ultrasound screen. Then, the midpoint of the long axis of the probe will be mark on the skin, without the requirement to precisely obtain the best image. • Spinal anesthesia: after disinfection and draping will be complete, the probe will be covered with ultrasound gel and a medical sterile protective sheath. The probe will be held in the non dominant hand, while the needle will be inserted using the dominant hand. One of the following 3 approaches will be utilize for real-time ultrasound–guided spinal anesthesia. 1. Para median sagittal in-plane (PMSI) approach 2. Para median sagittal out-plane (PMSO)approach 3. Para median transverse in-plane (PMTI)approach  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Eligible participants are patients more than 65 years of age with American Society of Anesthesiology (ASA) physical status I-III who will be scheduled for elective total hip replacement surgery under spinal anesthesia in the supine position. 
 
ExclusionCriteria 
Details  BMI more than 30kg/m2,
Taking angiotensin converting enzyme inhibitors,
Emergency cases
Absolute correlative contraindications to spinal anesthesia,
Patients with a baseline arterial SBP less than 90mmHg or mean arterial blood pressure (MBP) less than 60 mmHg .

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
first attempt success rates
 
“first-attempt” defined as the needle achieving successful Dural-puncture through a single attempt.


 
 
Secondary Outcome  
Outcome  TimePoints 
First pass success rates
Number of passes
Locating time
Procedure time
Total time
Patient satisfaction score
Procedural difference
 

duration of study will be 18 months
 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   14/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Spinal anesthesia is frequently used in clinical practice. It is frequently used in various orthopedic surgeries. It has advantages such as rapid onset of action, cost effectiveness, ease of administration and relatively fewer side effects. Spinal anesthesia has a number of advantages, including quick onset, complete blockade, and little effect on cardiopulmonary- nary function, that make it suitable for use in old age group however, performing spinal anesthesia by landmark-guided approach can be challenging in elderly patients posted for total hip replacement surgery due to lumbar degeneration, moderate to severe arthritis of hip(rheumatoid or post traumatic arthritis).1–4 Spinal anesthesia is widely performed using a surface landmark-based “blind” technique in which

 Multiple   attempts may lead to a higher incidence of  complications  (e.g., postural puncture headache,  paresthesia, hematoma, and infection) and increase  patient discomfort and dissatisfaction.5–7 Spinal anesthesia is conventionally performed using a landmark-guided midline approach. Various modifications have been described to reduce the morbidity related to repeated attempts and passes. These include a pre-procedure ultrasound-guided midline approach, real-time ultrasound-guided approach, landmark-guided Para median approach and pre-procedure ultrasound-guided Para median approach. Ultrasound is beneficial only in patients administered a single shot spinal anesthetic who have difficult surface landmarks or abnormal anatomy. There are insufficient data to support the routine use of ultrasound in all patients.

 

Therefore, novel techniques are needed to improve the success rate of spinal anesthesia for such patients.

Recently, ultrasound has emerged as a way to facilitate lumbar neuraxial blocks, namely, the ultra- sound assistance (USAS) technique and the real-time ultrasound guidance (USRTG) technique. The USAS technique is beneficial for lumbar neuraxial anesthesia, improving technique performance by providing reliable anatomical information.8–10 Previous studies have shown that pre puncture ultrasound scanning can improve success rates, shorten puncture time, reduce needle passes, and increase the efficacy and safety of lumbar neuraxial blocks.2,11–13 However, a problem with the USAS approach is that the needle is advanced blindly and sometimes  achieves an ideal trajectory and sometimes not. One possible remedy, reported in recent studies, is the USRTG technique, which provides real-time observation of the trajectory of the needle during the puncture process.14–17 However, the USRTG technique is technically difficult to perform. Since few studies comparing the 2 techniques have been done to date, no clear indication exists of which ultrasound technique is more suitable for use in elderly patients posted for Total Hip Replacement (THR) surgery.

Therefore, this study aimed to compare the first- attempt success rate of both the USAS and USRTG techniques in elderly patients posted for THR surgery. The first-pass success rate, procedure time, adverse reactions and complications, patient satisfaction, and procedural difficulty score were also compared between the 2 techniques.

 
Close