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
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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 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 |
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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 |
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Source of Monetary or Material Support
|
DR RML IMS, LUCKNOW, 226010 |
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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 |
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Details of Secondary Sponsor
|
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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 |
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Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
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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
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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 .
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
Blinding/Masking
|
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Primary Outcome
|
Outcome |
TimePoints |
first attempt success rates
|
“first-attempt†defined as the needle achieving successful Dural-puncture through a single attempt.
|
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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
|
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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
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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. |