CTRI Number |
CTRI/2023/06/053932 [Registered on: 15/06/2023] Trial Registered Prospectively |
Last Modified On: |
14/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of pericapsular nerve group block and femoral nerve block for analgesia after hip fracture surgery |
Scientific Title of Study
|
Randomized Comparative Study of Ultrasound Guided Pericapsular Nerve Group Block vs Femoral Nerve Block for postoperative analgesia in hip fracture surgery in Department of Anaesthesia, SMS Medical College, Jaipur. |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mamta Khandelwal |
Designation |
Senior Professor |
Affiliation |
SMS Medical College |
Address |
Department of Anaestehsia, SMS Medical College, Jaipur.
Jaipur RAJASTHAN 302004 India |
Phone |
9929338174 |
Fax |
|
Email |
drmamtakhandelwal@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
Dr Mamta Khandelwal |
Designation |
Senior Professor |
Affiliation |
SMS Medical College |
Address |
Department of Anaestehsia, SMS Medical College, Jaipur.
RAJASTHAN 302004 India |
Phone |
9929338174 |
Fax |
|
Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Darshan N |
Designation |
Junior Resident |
Affiliation |
SMS MEDICAL COLLEGE |
Address |
Department of Anaestehsia, SMS Medical College, Jaipur.
Jaipur RAJASTHAN 302004 India |
Phone |
9611831038 |
Fax |
|
Email |
drdarshan817@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Sawai Man Singh Medical College |
Address |
Department of Anaestehsia, Second Floor, Dhanwantri OPD Block, SMS Medical College, Jaipur. |
Type of Sponsor |
Government 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 |
Dr Mamta Khandelwal |
SMS Medical College |
Department of Anaesthesia, Second Floor, Dhanwantri OPD Block, SMS Medical College Jaipur RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Office of the Ethics Committee, SMS Medical College and Attached Hospitals |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
USG guided FNB in 40 patients |
Patients will receive ultrasound guided Femoral nerve block with 20 ml of 0.5% Ropivacaine(13.3mL of 0.75% Ropivacaine + 6.7mL of Normal Saline). NRS score will be assessed at an interval of 1 minute, up to 20 minutes until NRS less than 3. This time will be noted. In the postoperative period, the analgesic efficacy will be assessed at various intervals for 24 hours. |
Intervention |
USG guided PENG block in 40 patients |
Patients will receive ultrasound guided Pericapsular Nerve Group Block with 20ml of 0.5% Ropivacaine (13.3mL of 0.75% Ropivacaine + 6.7mL of Normal Saline). NRS score will be assessed at an interval of 1 minute, up to 20 minutes until NRS less than 3. This time will be noted. In the postoperative period, the analgesic efficacy will be assessed at various intervals for 24 hours. |
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Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients undergoing elective surgery for hip fracture, with NRS >7.
Patients consenting to participate.
Adult patients aged 30-70 Years.
Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.
|
|
ExclusionCriteria |
Details |
Patients with psychiatric illness, anxious, agitated.
Patients with peripheral sensorineural deficit.
Patients allergic to local anesthetics.
Patients with contraindications to regional anaesthesia.
o Patients with suspected compartment syndrome in lower limbs.
Patients on analgesia within 8 hours before performing nerve block.
Block failure cases (If NRS score is not < 3 within 20 min of performing peripheral nerve block).
|
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Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.To assess and compare pain by NRS at different time intervals in the postoperative period in both the groups.
2.To observe the change in NRS at one minute interval maximum up to 20 minutes after administration of block, until NRS less than 3 for positioning of patient for spinal anaesthesia.
3.To determine the difference in mean time of first rescue analgesia by using NRS and mean dose of analgesic required in 24 hours in both groups.
|
1.To assess and compare pain by NRS at hourly intervals till 6hrs and two hourly intervals till 24 hrs postoperatively.
2.To observe the change in NRS at one minute interval up to 20 minutes after administration of block, for positioning of patient for spinal anaesthesia.
3.To determine the mean dose of analgesic required in 24 hours in both groups.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To asses quadriceps muscle strength using Oxford muscle strength grading.
2. To determine the change in the haemodynamic parameters (HR, SBP, DBP, MAP & SpO2) in both groups.
3. To assess patient satisfaction.
4. To observe side effect or complication, if any.
|
1.To asses quadriceps muscle strength using Oxford muscle strength grading at hourly intervals till 6hrs & two hourly intervals till 24 hrs postoperatively.
2.To determine the change in the haemodynamic parameters (HR, SBP, DBP, MAP & SpO2) in both groups at hourly intervals till 6hrs & at two hourly intervals till 24 hrs .
3.To assess patient satisfaction after 24hrs postoperatively.
4.To observe side effect or complication, if any.
|
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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 1/ Phase 2 |
Date of First Enrollment (India)
|
25/06/2023 |
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="10" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Hip fractures are regarded as a worldwide epidemic and a major public health concern inmany countries (1). Globally, hip fractures rank among the top 10 causes of disability (2). Hipfractures are a common orthopaedic emergency in the elderly, and is associated with significant mortality and morbidity. Surgical reduction and fixation are the definitive treatment in most patients (3). The majority of hip fractures in the elderly population results from an inadvertent fall,whereas, it is more commonly caused due to a high energy trauma in the younger and adultpopulation (4). Irrespective of the aetiology, hip fractures are a painful condition, and early pain relief and definitive management is of utmost importance, especially in the elderly population. Pre-operative pain from hip fractures can be managed by several modalities. The 2011 NICE guidelines for management of hip fractures recommend the use of IV paracetamol, opioids,and peripheral nerve blocks (5). Oral or intravenous analgesics, particularly opioids can cause unwarranted sedation, nausea, vomiting, respiratory depression, and delirium. The elderly population have a significant risk of delirium due to their age, co-morbidities, alteredmetabolic functions and physiology, or due to the under or over treatment of pain (6, 7). Peripheral nerve blocks have several advantages such as, adequate pain management in thepre- operative and post-operative time, facilitate early mobilization, and reduction in the dose of opioids required and their related side effects (3, 8). The hip joint is innervated by branches of the obturator nerve, anterior obturator nerve, andthe femoral nerve. Studies suggest that the anterior capsule of the hip joint is richlyinnervated by these nerves and is targeted to provide analgesia. Regional anaesthetic techniques such as Femoral Nerve Block (FNB), and Fascia Iliaca Block (FIB) are routinely used for effective peri-operative analgesia due to opioid sparing effects. But, these blockades only provide moderate analgesia as the obturator nerve is inadequately affected (3, 9). Ultrasound guidance improves visualization of anatomical structures, success rate, quality of sensory block, onset time, decreases dose of local anesthetics and complications. The Femoral Nerve Block targets the lateral femoral cutaneous nerve, femoral nerve, and the obturator nerve (9). The Pericapsular Nerve Group Block targets the articular branches of obturator nerve, anterior obturator nerve, and the femoral nerve, and is found to be aneffective regional anaesthetic technique for hip fracture surgeries (10).
After thorough review, there are very few studies that compare the efficacy of ultrasound guided PENG vs FNB for postoperative analgesia in patients who underwent surgery for hip fracture using 20mL of 0.5% Ropivacaine. |