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
|
|
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
|
|
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. |