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CTRI Number  CTRI/2024/11/077029 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Spinal anesthesia method for surgery: landmark vs ultrasound guided 
Scientific Title of Study   Comparison of efficacy of ultrasound guided and conventional landmark technique in patients with difficult spine predictors for spinal anesthesia: open RCT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushmitha 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Bibi Nagar 
Address  Department of Anesthesiology All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region, Telangana

Nalgonda
TELANGANA
508126
India 
Phone  9449554515  
Fax    
Email  sushmithaa1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Bibi Nagar 
Address  Department of Anesthesiology All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region, Telangana

Nalgonda
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ayya Syama Sundar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Bibi Nagar 
Address  Department of Anesthesiology All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region, Telangana

Nalgonda
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bibi Nagar, Hyderabad Metropolitan Region Telangana-508126 Hyderabad India 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesBibinagar 
Address  All India Institute Of Medical Sciences Bibi Nagar Hyderabad Metropolitan Region Telangana 508126 India 
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 Ayya Syama Sundar  All India Institute of Medical Sciences, Bibi Nagar  Room number G35 and G36 Operation Theater Complex Department of Anesthesiology All India Institute of Medical sciences, Bibi Nagar Hyderabad Metropolitan Region
Nalgonda
TELANGANA 
8179309677

sasyasyama@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Landmark technique of spinal anesthesia  In the conventional landmark group, patients with difficult spinal predictors, iliac crests, spinous process and interspinous gaps will be palpated to determine the midline and the target intervertebral space. The marking will be done in the OT 5 minutes before surgery and proceeded onto spinal anesthesia. 
Intervention  Ultrasound guidance for visualization of subarachnoid space  In patients with difficult spinal predictors in the ultrasound group, imaging of the lumbar spine will be done to obtain the midline and transverse interlaminar view. The intersection of these two markings will guide the midline approach during the spinal anesthesia procedure. The marking will be done in the OT 5 minutes before surgery and proceeded onto spinal anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with difficult spinal predictors
Elective surgery requiring Spinal Anesthesia
ASA 1 and 2 
 
ExclusionCriteria 
Details  Patients with severe cardiopulmonary diseases
contraindications of spinal anesthesia
inability to communicate/co-operate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compare the first attempt success rate between the two groups   Within 5 minutes after completion of the procedure. There is only one time point as no serial measurements will be taken. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of needle redirections
2.Number of attempts (including number of redirections & new needle insertions).
3.Spinal puncture point Recognition time
a. Time from operator contact with the patient’s skin to marking the puncture site on the skin–for landmark technique.
b. Time from placing the probe on the skin to marking the puncture site—for Ultrasound assisted technique.
4.Needling time—time from local anesthetic infiltration to CSF flow
5.Total procedural time—recognition time plus needling time
6.Number of persons attempted 
Within 5 minutes after completion of the procedure. There is only one time point as no serial measurements will be taken. 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   30/11/2024 
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="0"
Months="0"
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  
Neuraxial procedures are traditionally blind techniques where space is identified by palpation of anatomic landmarks namely iliac crests and spinous processes together with tactile feedback during needle  insertion and loss of resistance confirming entry into subarachnoid space. But the technical difficulty of neuraxial blockade correlates with the quality of palpable surface landmarks. Palpation is often inaccurate and these surface landmarks may be absent, indistinct or distorted in many adult patients because of obesity, previous spinal surgery, deformity or degenerative changes of aging, insufficient gap between the spinal vertebrae, skin distances from the subarachnoid space, size of the needles; therefore, failed blocks and complications are common. 
Repeated attempts and redirections of the needle may lead to nerve injury, spinal hematoma, post dural puncture headache and added discomfort to the patient. Multiple case reports demonstrate the utility of ultrasound in guiding neuraxial blockade in patients with difficult spinal anatomy. Ultrasound imaging provides information about the accurate intervertebral level of puncture, optimal needle insertion point and depth of needle advancement for a successful neuraxial block. But there has been only few RCTs in the Indian scenario on the subject. Therefore, we designed a study aimed to compare the efficacy between the preprocedural ultrasound assisted technique and the conventional landmark based technique in patients with predictors of difficult spinal posted for elective surgery under spinal anesthesia.
 
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