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CTRI Number  CTRI/2026/01/102053 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare between Ultrasound guided Pericapsular nerve group block and Suprainguinal fascia iliaca block for reducing pain during sitting position for spinal anaesthesia in patients of acetabular fractures undergoing open reduction and internal fixation 
Scientific Title of Study   A randomized comparative study to evaluate the efficacy of ultrasound guided pericapsular nerve group block versus ultrasound guided suprainguinal fascia Iliaca block for ease of positioning during spinal anaesthesia in cases of acetabular fractures posted for open reduction and internal fixation 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 Anaesthesia, Second floor, 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 Anaesthesia, Second floor, Dhanwantri building, JLN Marg, Jaipur, Rajasthan, India


RAJASTHAN
302001
India 
Phone  9829056816  
Fax    
Email  vandanamangal25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aarushi Bhanu 
Designation  Pg Student 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anaesthesia, Second floor, Dhanwantri building, JLN Marg, Jaipur, Rajasthan, India

Jaipur
RAJASTHAN
302001
India 
Phone  7018937892  
Fax    
Email  aarushi.bhanu@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, SMS Medical College, Jaipur, Rajasthan, Pin code- 302001, India  
 
Primary Sponsor  
Name  Sawai Man Singh Medical College and Hospital 
Address  Department Of Anaesthesia , Second floor, Dhanwantri building, SMS medical College, Jaipur, Rajasthan, Pin code- 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 Anaesthesiology, second floor, Dhanwantari building. SMS Hospital,JLN Marg, Jaipur, Rajasthan
Jaipur
RAJASTHAN 		 9829056816

vandanamangal25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College and attached hospitals, 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 
Comparator Agent  20 ml of 0.25% Bupivaicaine and 2mg Dexamethasone ( Ultrasound guided Supra-inguinal fascia iliaca block vs Pericapsular nerve group block ) Drug Total volume- 20.5 ml   Comparison in terms of ease of positioning during spinal anaesthesia 
Intervention  20ml of 0.25% Bupivaicaine and 2mg of Dexamethasone ( USG guided Pericapsular nerve group block )  The patient is placed in the supine position. Following sterile preparation, draping and using standard aseptic technique a curvilinear low-frequency ultrasound probe (2-5 Hz) is initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter-clockwise by approximately 45 degrees. In this orientation, the iliopubic eminence, psoas muscle and tendon, femoral artery, and the pectineus muscle are visualized. Under aseptic precautions, a 22 gauge, 80mm needle is inserted from lateral to medial in an in-plane approach to place the tip of the needle in the musculofascial plane between psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anaesthetic solution is injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 ml. Patient will be monitored for 24 hrs. 
Intervention  20ml of 0.25% Bupivaicaine and 2mg of Dexamethasone ( USG guided Suprainguinal fascia iliaca block )  The patient will be placed in the supine position. Following sterile preparation, draping and using standard aseptic technique the high-frequency linear transducer will be placed in the sagittal plane to identify the anterior superior iliac spine, and the transducer will be moved medially to identify the fascia iliaca, iliopsoas, sartorius, and internal oblique muscles. Using an in-plane approach, needle tip will be positioned deep in the fascia iliaca and above the iliacus muscle. After negative aspiration, 20 mL of 0.25% Bupivacaine will be injected incrementally under the fascial plane, aspirating every 5 mL. Patient will be monitored for 24 hrs.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients undergoing open reduction and internal fixation for acetabular fracture under spinal anaesthesia
2.Patients consenting to participate.
3.Adult patients aged 18-65 Years.
4.Patients belonging to American Society of Anesthesiologists(ASA) grade I, II and III 
 
ExclusionCriteria 
Details  1.Patients who will not be able to assist in block assessment.
2.Those with preexisting neuropathy.
3.Having coagulopathy .
4.Allergic to local anesthetics.
5.Infection at the local site of administration of block
6.Patient should not be part of any other study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess and compare NRS score at rest and on passive 15-degree limb elevation every 5min after the block till NRS less then 2 is achieved.
2. To assess and compare time taken to achieve NRS less then 2 in both the groups.
3. To assess and compare the difference in sitting angle before the block and at positioning for spinal anaesthesia between the two groups. 		 1. At baseline, 5 min, 10 min,15 min till NRS less then 2
2. At baseline, 5 min, 10 min, 15 min till NRS less then 2
3. At baseline, 15 min during positioning 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess & compare NRS postoperatively every 6 hrly for 24hr between the groups
2. To determine & compare amount of Tramadol iv (mg) used in first 24 hr postoperatively in both the groups.
3. To observe any block related side effects such as nausea vomiting respiratory depression & LAST if any. 		 1. At baseline, 6 hr 12 hr 18 hr 24 hr
2. At baseline 6 hr 12 hr 18 hr 24 hr
3. At baseline 6 hr 12 hr 18 hr 24 hr 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 2 
Date of First Enrollment (India)   04/02/2026 
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="8"
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  

Acetabular 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, fascia iliaca, supra inguinal fascia iliaca and peri capsular nerve group  block have been tried as part of multimodal analgesia.These days acetabular 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. Literature suggests both supra-inguinal fascia iliaca block and pericapsular nerve group block offer pain relief in acetabular fractures. We undertake this study  to find out which is superior. It is very important that patients are comfortable and are able to sit properly to give a good position making things comfortable both for patients and anaesthesiologists. Also, the central neuraxial block can be done atraumatically, very basic requirement in central neuraxial blocks.In this study we aim to evaluate the efficacy of Supra-inguinal fascia iliaca block versus Pericapsular nerve group block for ease of positioning during spinal anaesthesia in acetabular fractures posted for open reduction and internal fixation using 20ml of o.25% Bupivacaine and 2mg Dexamethasone.

 
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