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CTRI Number  CTRI/2024/04/065003 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Ultrasound-guided combined Nerve Group blocks and single nerve group block as perioperative pain relief in patients posted for hip surgeries under Spinal Anesthesia – Randomized Controlled Trial 
Scientific Title of Study   Comparison of Ultrasound-guided Pericapsular Nerve Group Block with and without Supra inguinal Fascia Iliaca Compartment Block as perioperative analgesia in patients posted for hip surgeries under Spinal Anesthesia – Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Divya Bhatkar 
Designation  Post graduate resident 
Affiliation  AIIMS Bathinda 
Address  Department of Anesthesiology and Critical Care, AIIMS Bathinda, Mandi Dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8425859163  
Fax    
Email  dpbhatkar98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anju Grewal 
Designation  Professor and Head of Department 
Affiliation  AIIMS Bathinda 
Address  Department of Anesthesiology and Critical Care, AIIMS Bathinda, Mandi Dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9815482626  
Fax    
Email  dranjugrewal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gopal Krishan Jalwal 
Designation  Assistant Professor 
Affiliation  AIIMS Bathinda 
Address  Department of Anesthesiology and Critical Care, AIIMS Bathinda, Mandi Dabwali road, Bathinda

Bathinda
PUNJAB
151001
India 
Phone  7838939833  
Fax    
Email  gopaljalwal@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, Bathinda Mandi Dabwali Road, Bathinda, Punjab-151001 India 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Bathinda 
Address  All India Institute Of Medical Sciences Bathinda, Mandi Dabwali road, Bathinda, Punjab, Pin code- 151001. 
Type of Sponsor  Research institution and hospital 
 
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 Divya Bhatkar  All India Institute Of Medical Sciences, Bathinda  Room no 145, Department of Anesthesiology and Critical Care, All India Institute Of Medical Sciences Bathinda, Mandi Dabwali road, Bathinda, Punjab, Pin code- 151001.
Bathinda
PUNJAB 
8425859163

dpbhatkar98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute Of Medical Sciences, Bathinda Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: W010||Fall on same level from slipping,tripping and stumbling without subsequent striking against object,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A patients will receive Ultrasound-guided PENG block and SIFICB in the preoperative room in supine position.  Technique of PENG block The patient will be positioned supine. The block will be performed under absolute aseptic precautions using a low-frequency Ultrasound probe with an echogenic peripheral nerve block needle (Stimuplex Ultra). In order to perform the block, the low-frequency probe of the Ultrasound machine (Sonosite Fujifilm Inc. USA) will be positioned parallel to the inguinal ligament at the level of the anterior superior iliac spine (ASIS), and scanning will proceed with a gradual movement of the probe caudally, keeping the probe parallel to the inguinal ligament. When the lower anterior inferior iliac spine (AIIS) is visible, the probe will be moved medially in such a way that a continuous hyperechoic shadow of the upper pubic ramus is seen. This method will identify the iliopsoas muscle, which has a conspicuous tendon immediately above the pubic ramus. The target plane to deposit local anaesthetic is between the pubic ramus and iliopsoas tendon (hyperechoic structure just above the pubic ramus). Using the in-plane approach, the 22G, 10 cm long, echogenic needle will be advanced in the musculofascial plane between the psoas tendon and the pubic ramus, lateral to the medial side. Hydro dissection and spread under the illo-psoas muscle will reveal the needles precise site and 20ml of 0.2% ropivacaine will be injected.(14) Technique of SIFICB - This block will be accomplished with a high-frequency linear ultrasonic transducer probe (Fujifilm sonosite USA) under aseptic precautions. The patient will be positioned supine to perform the block. The probe will be positioned in the para-sagittal plane over the inguinal ligament near the anterior superior iliac spine. The thick white line of the ilium will first be detected, followed by the more superficial, black (hypoechogenic) iliacus muscle with the fascia iliaca covering its surface then the probe will be moved inferior and medially until you visualise the anterior inferior iliac spine and bow tie sign (confluence of oblique muscle one side and sartorius on another side over the fascia iliaca). The deep circumflex iliac artery, which gives a landmark for needle placement, can be located superficial to the fascia iliaca 1-2 cm superior to the inguinal ligament. The needle (Stimuplex ultra) will be inserted through the in-plane technique (caudal to cranial), and will be moved through the fascia iliaca at the inguinal ligament level. The needle frequently makes a pop when it traverses through the fascia iliaca and enters the iliacus muscle . Through the process of hydro-dissection, the needle will be advanced superiorly, deep into the fascia iliaca. The local anaesthetic must be able to spread across the surface of the iliacus muscle freely. When the local anaesthetic freely travels superiorly across the iliacus muscle, and into the iliac fossa, the endpoint will be achieved. At this site, a total of 20 mL of ropivacaine 0.2% will be administered.(3)  
Comparator Agent  Group B patients will receive Ultrasound guided PENG block alone in the preoperative room in supine position.  Technique of PENG block The patient will be positioned supine. The block will be performed under absolute aseptic precautions using a low-frequency Ultrasound probe with an echogenic peripheral nerve block needle (Stimuplex Ultra). In order to perform the block, the low-frequency probe of the Ultrasound machine (Sonosite Fujifilm Inc. USA) will be positioned parallel to the inguinal ligament at the level of the anterior superior iliac spine (ASIS), and scanning will proceed with a gradual movement of the probe caudally, keeping the probe parallel to the inguinal ligament. When the lower anterior inferior iliac spine (AIIS) is visible, the probe will be moved medially in such a way that a continuous hyperechoic shadow of the upper pubic ramus is seen. This method will identify the iliopsoas muscle, which has a conspicuous tendon immediately above the pubic ramus. The target plane to deposit local anaesthetic is between the pubic ramus and iliopsoas tendon (hyperechoic structure just above the pubic ramus). Using the in-plane approach, the 22G, 10 cm long, echogenic needle will be advanced in the musculofascial plane between the psoas tendon and the pubic ramus, lateral to the medial side. Hydro dissection and spread under the illo-psoas muscle will reveal the needles precise site and 20ml of 0.2% ropivacaine will be injected.(14)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients of age group 18-80 years
American Society of Anesthesiologists physical status I, II and III
Patients undergoing hip surgery under spinal anesthesia.
 
 
ExclusionCriteria 
Details  Patients with history of opioid usage
Patients with history of peripheral neuropathy
Patients with history of Neuromuscular disorders
Polytrauma patients or patients with other fractures
Patients with history of bleeding disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the time to first analgesic request post operatively in both the patient groups undergoing the respective blocks.  We will assess pain levels using the Numeric Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at 6, 12, 18, and 24 hours after the surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To calculate Ease Of Spinal Positioning (EOSP) score after positioning for spinal anesthesia
2)To determine Numerical Rating Scale pain Scores at rest and at 15° leg elevation in both the groups undergoing the respective blocks.
3) To determine the total dose of analgesic requirement in the first 24hrs after surgery in both patient groups.
 
Assess pain levels using the Numeric Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at 6, 12, 18, and 24 hours after the surgery. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/04/2024 
Date of Study Completion (India) 10/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

In this prospective randomized study, the patients will be enrolled based on the inclusion and exclusion criteria. All the patients eligible for the study will undergo a preoperative assessment and will be explained thoroughly about the study. A detailed patient information sheet will be given to these selected patients. Written informed consent in vernacular language will be taken prior to the study from all the patients participating in the trial. The study will start once the patient arrives in the preoperative room. Preoperative instructions on how we will assess the perioperative pain using Numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain), will be explained to patients. Intra-venous access will be obtained before arrival in operation theatre.

 

The preoperative Numerical Rating Scale pain scores at rest and at 15 ° leg elevation will be recorded. Under all aseptic precautions, Group A patients will receive Ultrasound-guided PENG block and SIFICB and Group B patients will receive Ultrasound guided PENG block alone in the preoperative room in supine position  as described below.

Technique of PENG block

The patient will be positioned supine. The block will be performed under absolute aseptic precautions using a low-frequency Ultrasound probe with an echogenic peripheral nerve block needle (Stimuplex Ultra). In order to perform the block, the low-frequency probe of the Ultrasound machine (Sonosite Fujifilm Inc. USA) will be positioned parallel to the inguinal ligament at the level of the anterior superior iliac spine (ASIS), and scanning will proceed with a gradual movement of the probe caudally, keeping the probe parallel to the inguinal ligament. When the lower anterior inferior iliac spine (AIIS) is visible, the probe will be moved medially in such a way that a continuous hyperechoic shadow of the upper pubic ramus is seen. This method will identify the iliopsoas muscle, which has a conspicuous tendon immediately above the pubic ramus. The target plane to deposit local anaesthetic is between the pubic ramus and iliopsoas tendon (hyperechoic structure just above the pubic ramus). Using the in-plane approach, the 22G, 10 cm long, echogenic needle will be advanced in the musculofascial plane between the psoas tendon and the pubic ramus, lateral to the medial side. Hydro dissection and spread under the illo-psoas muscle will reveal the needle’s precise site and 20ml of 0.2% ropivacaine will be injected.(14)

Technique of SIFICB - This block will be accomplished with a high-frequency linear ultrasonic transducer probe (Fujifilm sonosite USA) under aseptic precautions. The patient will be positioned supine to perform the block.  The probe will be positioned in the para-sagittal plane over the inguinal ligament near the anterior superior iliac spine. The thick white line of the ilium will first be detected, followed by the more superficial, black (hypoechogenic) iliacus muscle with the fascia iliaca covering its surface then the probe will be moved inferior and medially until you visualise the anterior inferior iliac spine and bow tie sign (confluence of oblique muscle one side and sartorius on another side over the fascia iliaca). The deep circumflex iliac artery, which gives a landmark for needle placement, can be located superficial to the fascia iliaca 1-2 cm superior to the inguinal ligament. The needle (Stimuplex ultra) will be inserted through the in-plane technique (caudal to cranial), and will be moved through the fascia iliaca at the inguinal ligament level. The needle frequently makes a ’pop’ when it traverses through the fascia iliaca and enters the iliacus muscle . Through the process of hydro-dissection, the needle will be advanced superiorly, deep into the fascia iliaca. The local anaesthetic must be able to spread across the surface of the iliacus muscle freely. When the local anaesthetic freely travels superiorly across the iliacus muscle, and into the iliac fossa, the endpoint will be achieved. At this site, a total of 20 mL of ropivacaine 0.2% will be administered.(3)

The NRS at rest and with 15° leg elevation will be measured 10 min later after the completion of both blocks. Standard ASA monitors will be attached electrocardiogram (ECG), pulse oximetry (SpO2), non-invasive blood pressure (NIBP); on their arrival in operation theatre.

The Ease Of Spinal Positioning (EOSP) will be assessed on the scale of 0–3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain).(11) Subarachnoid block will be performed with 15 mg bupivacaine (3 ml of a 0.5% solution) after confirming free flow of cerebrospinal fluid to achieve sensory block at or above T10 dermatome.

Intraoperative fluids and blood will be administered according to the requirement. After the surgery, all patients will be transferred to the post-anesthesia care unit (PACU) and will be given a 1gm dose of intravenous paracetamol, followed by 8 hourly in the postoperative period. We will assess pain levels using the Numeric Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at 6, 12, 18, and 24 hours after the surgery. If NRS >/=4 then inj fentanyl 25 mcg bolus will be given to the patients. Post operatively, we will monitor the patients hemodynamic parameters, NRS pain scores, duration of pain relief (the time from completing both procedures to the patient’s first dose of rescue pain relief) and the total analgesic consumption over 24hrs will be recorded.(3)

 

 
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