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CTRI Number  CTRI/2025/12/098746 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 07/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Obsevational study 
Study Design  Other 
Public Title of Study   An Observational Study Evaluating the Outcome of Anterior Quadratus Lumborum Block as an Analgesic Intervention among participants Undergoing Open Reduction and Internal Fixation for Acetabular Fracture under Spinal Anesthesia  
Scientific Title of Study   An Observational study of Anterior Quadratus Lumborum Block in ease of positioning for spinal anesthesia among fracture acetabulum cases at SMS Medical College, Jaipur. 
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 Vandana Mangal  
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India
Department of Anesthesiology , Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India
Jaipur
RAJASTHAN
302001
India 
Phone  9829056816  
Fax    
Email  vandanamangal25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Mangal  
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anesthesioloy, Second floor, Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India
Department of Anesthesiology Dhanwantri Building JLN Marg ,Jaipur, Rajasthan, India
Jaipur
RAJASTHAN
302001
India 
Phone  9829056816  
Fax    
Email  vandanamangal25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kiran Goyal 
Designation  Pg Student 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anesthesia, Second floor, Dhanwantri building JLN Marg ,Jaipur, Rajasthan, India
274, Gurunankpura Tilak nagar,Raja park ,Jaipur, Rajasthan, India
Jaipur
RAJASTHAN
302001
India 
Phone  9521013574  
Fax    
Email  Kirangoyal1769@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia,second floor Dhanwantri building,JLN Marg, , Jaipur,Rajasthan 302001 India 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College and Hospital 
Address  Department of Anesthesia ,Second floor , Dhanwantri building, SMS Medical College, Jaipur,Rajasthan 302001 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 Vandana Mangal  SMS Medical college and Hospital , Jaipur  Department of Anesthesia Second Floor Dhanvantri Building SMS Hospital, Jaipur
Jaipur
RAJASTHAN 
9829056816

vandanamangal25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF ETHICS COMMITTEE, S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Patients undergoing open reduction and internal fixation for fracture acetabulum
• In age group of 18-65 years of both sexes.
• Patients belonging to American Society of Anaesthesiologists (ASA) class I, II and III.
• Patients giving consent for participation.

 
 
ExclusionCriteria 
Details  • Patient should not be a part of any other study.
• Patients allergic to local anaesthetic(Ropivacaine)
• Local pathology at the injection site.
• Patients with neurological, psychiatric, neuromuscular disease or patient not able to tell block assessment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess and compare difference in NRS from baseline , 5 min , 30 min after the block.
2. To assess and compare Mean Time taken 5 min to 30 min achieve NRS less then 2 for assessing sitting position for spinal anesthesia.
3. To assess and compare the difference in sitting angle before the block and at positioning for spinal anesthesia.(NRS less then 2)
4. To assess good positioning for CSE anesthesia in terms of number of pricks for successful lumbar puncture
 
1. To assess and compare difference in NRS from baseline at 5 min ,10min ,15 min,20 min, 25 min, 30 min after the block.
2. To assess and compare Mean Time taken 5min to 30 min achieve NRS less then 2 for assessing sitting position for spinal anesthesia.
3. To assess and compare the difference in sitting angle before the block and at positioning for spinal anesthesia.(NRS less then 2)
4. To assess good positioning for CSE anesthesia in terms of number of pricks for successful lumbar puncture
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess post-operative analgesia at 6,12,18,24 hours in cases of spinal anesthesia.

 
post operative analgesia at 6,12,18,24 hours 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   20/12/2025 
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="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  

Acetabulum fractures although constitute only 1.5 -3% of geriatric orthopaedic trauma but are on the rise. A large proportion of them are elderly with multiple comorbidities and their associated challenges. It is a painful condition both at rest and on slight movement.  good  perioperative analgesia is mandatory for these patients, like in any other orthopaedic trauma.  Many recipes have been tried for perioperative pain relief ranging from systemic analgesia with or without opioids to multimodal analgesia.  Many regional blocks   like femoral nerve block, 3 in 1, fascia ilaca, supra inguinal fascia ilaca and peri capsular nerve group  block have been tried as part of multimodal analgesia.

These days acetabulum fractures are fixed surgically, anaesthesia of choice for these patients is central neuraxial block and many times combined spinal epidural for both long duration surgeries and postoperative analgesia. For these blocks sitting position is preferable as patients find it difficult to lie on the side. To perform these blocks successfully in one go the patient has to be pain free and comfortable. Systemic analgesia is a choice, but at times it does not offer adequate analgesia and patient sometimes feel a little dizzy if they are given opioids. So we all look forward to good regional blocks for effective analgesia during positioning these patients for central neuraxial blocks.

Blanco introduced the Quadratus Lumborum block in 2007 and it is now emerging as new regional block that has performed favourably in lower abdominal surgery and is being evaluated for hip analgesia.  It is believed to provide pain relief for patients with hip fractures because it has multiple approaches. Cadaveric studies of the QLB showed direct dye spread to the roots and branches of the lumbar plexus; thus, these studies supported the possible benefit of QLB in hip surgeries. However, the anterior approach is being tried because the posterior and lateral approaches are not possible for these patients. The drug is deposited between the quadratus lumborum and the psoas muscle in this block, where it seeps up to the lumbar plexus. Therefore, we wish to assess the effectiveness of analgesia of anterior quadratus lumborum block for positioning patients with fracture acetabulum for spinal anesthesia.

 

 
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