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CTRI Number  CTRI/2023/10/058678 [Registered on: 16/10/2023] Trial Registered Prospectively
Last Modified On: 12/05/2024
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   Ultrasound-guided pericapsular nerve group block following hip arthroplasty for postoperative analgesia  
Scientific Title of Study   Ultrasound-guided pericapsular nerve group block for postoperative analgesia following hip arthroplasty 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khagol Bhatnagar 
Designation  Resident Aanaesthesia 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department Of Anaesthesiology and pain management, SRHU HIMS, Jolly Grant Dehradun, 248140
Department Of Anaesthesiology and pain management, SRHU HIMS, Jolly Grant Dehradun, 248140
Dehradun
UTTARANCHAL
248140
India 
Phone  9711806326  
Fax    
Email  khagol02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rohan Bhatia 
Designation  Associate Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department Of Anaesthesiology and Pain Management, SRHU HIMS, Jolly Grant Dehradun, 248140
Department Of Anaesthesiology and Pain Management, SRHU HIMS, Jolly Grant Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  9971014232  
Fax    
Email  rohanbhatia@srhu.edu.in  
 
Details of Contact Person
Public Query
 
Name  ROHAN BHATIA 
Designation  Associate Professor 
Affiliation  HIMALAYAN INSTITUTE OF MEDICAL SCIENCE 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND PAIN MANAGEMENT, SRHU HIMS, JOLLY GRANT DEHRADUN, 248140


UTTARANCHAL
248140
India 
Phone  9971014232  
Fax    
Email  rohanbhatia@srhu.edu.in  
 
Source of Monetary or Material Support  
Swami Rama Himalayan University Jolly Grant, Dehradun, 248140 
 
Primary Sponsor  
Name  Swami Rama Himalayan University 
Address  SRHU HIMS, Jolly Grant, Dehradun 248140, Uttrakhand, India 
Type of Sponsor  Private 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 
Rohan Bhatia  Swami Rama Himalayan Institute, HIMS  Department Of Anaesthesiology And Pain Management, Fisrt Floor, HIMS SRHU, Jolly Grant 248140 Dehradun, UK, India
Dehradun
UTTARANCHAL 
9971014232

rohanbhatia@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SWAMI RAMA HIMALAYAN UNIVERSITY  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, (2) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular Nerve Group Block  Group 1 Pericapsular Nerve Group Block with 20ml of 0.5% Ropivacaine for Hip Arthroplasty will be given after spinal anaesthesia with 3ml 0.5% hyperbaric Bupivacaine and post operative intravenous PCA Pump will be provided for 24 hours with Tramadol demand dose of 20 mg and lockout interval of 20 minutes. 
Comparator Agent  STANDARD TREATMENT, NO PENG BLOCK  Standard Spinal with 3ml Bupivacaine and post operative IV PCA pump of Tramadol with demand dose of 20mg and lockout interval of 20 minutes will be provided for 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Type of hip surgery- Total Hip Arthroplasty, Hemiarthroplasty, Revision Arthroplasty
American Society of Anaesthesiologist (ASA) physical status Grade I and II 
 
ExclusionCriteria 
Details  Patient refusal for Regional Anaesthesia.
Known allergies to Local anaesthetics.
Bleeding disorders
Infection at local site
Severe Liver and kidney disfunction
BMI above 30 kg/m2
Inability to give informed consent
Inability to operate PCA pump
Psychiatric Disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post Operative pain relief using NRS scoring scale  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Total opioid consumption over 24 hours
Duration of the first rescue analgesic used over 24 hours (time from PACU discharge to first requested analgesic)
Ability to Straight Leg Raise without any assistance on post operative day (POD) 1.
Any opioid related side effects within the first 24 hours
Any block related side effects in the first 24 hours
Patient satisfaction utilising a Likert-scale questionnaire on POD 1 
24 HOURS 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/10/2023 
Date of Study Completion (India) 15/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

Post operative pain is a major concern after any surgery. Immediate post operative period pain leads to delayed mobilisation and increased expenses due to a longer hospital stay. Inadequate analgesia after surgery is associated with increased incidences of chronic pain. Advanced techniques to provide multimodal analgesia like peripheral nerve blocks are being researched and published everyday. Newer avenues for perioperative pain control have been made possible by the use of ultrasonography in regional anaesthesia (1).

Acute post operative pain is a very common finding after hip surgeries and ranges all the way from moderate to severe. It is also a widely known risk factor for chronic pain in joint replacement surgeries (2).

Regional anaesthesia techniques that are currently being practised to manage post-operative pain in hip surgeries include epidural analgesia, femoral block, obturator block, sciatic block, fascia iliaca compartment block, erector spinae plane block and quadratus lumborum block. Epidural analgesia is still the approach of choice around the world but it does have its disadvantages which include hypotension, loss of bladder control, inadequate pain relief, bilateral block, prolonged motor nerve block and epidural hematoma (3).

The use of ultrasound guided regional analgesia is an upcoming and rapidly progressive method of pain management which allows for a far better management of post operative pain leading to reduced use of opioids in the post operative period along with reduction in their adverse effects like nausea, vomiting, somnolence and constipation (4).

Pericapsular Nerve Group (PENG) block is the latest technique used for hip surgeries which is gaining massive popularity due to its involvement of the obturator nerve and motor sparing capability.

Giron-Arango was the first to describe the ultrasound-guided Pericapsular Nerve Group (PENG) block. It is used to block all the sensory branches which are innervating the anterior capsule of the hip joint i.e. femoral, obturator, accessory branch of obturator nerve thereby minimising any motor impairment and allowing faster mobilization (5).

The musculo-fascial plane surrounded posteriorly by the pubic ramus  and anteriorly by the psoas tendon is described as the block’s target site. With the patient in supine posture the ultrasound probe is first positioned in the transverse plane across the anterior superior iliac spine, and is then turned roughly 45 degrees counterclockwise. Before insertion of needle, the iliopubic eminence, iliopsoas muscle and tendon, femoral artery and pectinous muscle are brought into view and the musculo-fascial plane between the pubic ramus and psoas tendon is where the medication is injected (6,7).

Pericapsular Nerve Group Block has an added advantage of blocking the Obturator nerve and its accompanying branches, which supply the anterior capsule of the hip that are spared by other regional anaesthetic techniques, which primarily target the femoral nerve supplying the hip region only. Since the target area lies close to subpectineal plane, it is believed that the branches of the obturator nerve that supply the anterior capsule of the joint are successfully blocked along with the femoral and obturator nerve. With advances in ultrasound guidance, the Pericapsular Nerve Group (PENG) Block is one such modality that offers sensory block to all three nerve in a single injection site (8).

The ideal injection position, the best anaesthetic concentration, the overall volume of the medicine to be injected and combination with other blocks are topics that are still up for debate because of the novelty of this procedure. Latest research papers describe the use of PENG block in conjunction with local and intravenous analgesics for hip arthroplasty or hip arthroscopy (combined with lateral femoral cutaneous nerve LFCN block) and Hemiarthroplasty (comparing it with femoral block) (9).

Patient controlled analgesia pumps (PCA pump) is one modality that is given along with peripheral nerve blocks to reduce post operative pain as it freely allows the patient to control his desired level of analgesia that ultimately ends with patient satisfaction (10).


In this study we use preoperative PENG block on various types of hip surgeries and compare its effects with a control group using NRS scoring system for postoperative pain relief. Also we compare the total post operative analgesic consumption between the two groups and evaluate patient satisfaction using Likert scale between the two groups.

 
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