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CTRI Number  CTRI/2024/07/070130 [Registered on: 07/07/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparitive study of ropivacaine vs ropivacaine with dexamethasone in ultrasound guided nerve block in patients undergoing hip surgery for preoperative and postoperative pain 
Scientific Title of Study   A Randomized Comparative Study Of Ropivacaine Vs Ropivacaine With Dexamethasone In Ultrasound Guided Pericapsular Nerve Group Block For Preoperative and Postoperative Analgesia In Patients Undergoing Elective Hip Surgery 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 Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  SMS Medical College and Hospital 
Address  Department of Anaesthesia,SMS Medical College,Jaipur. Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  SMS Medical College and Hospital 
Address  Department of Anaesthesia,SMS Medical College,Jaipur. Jaipur Rajasthan


RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chethan O S 
Designation  Junior Resident 
Affiliation  SMS Medical College and Hospital 
Address  Department of Anaesthesia,SMS Medical College,Jaipur. Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9972331362  
Fax    
Email  chethanos97@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College and Hospital Jaipur Rajasthan India 302001  
 
Primary Sponsor  
Name  SMS Medical College and Hospital 
Address  Department of Anaesthesia,2nd floor,Dhanvantri OPD Block, SMS Medical college Jaipur,Rajasthan India 302001 
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 Mamta Khandelwal  SMS Medical College and Hospital  Department of Anaesthesia,2nd floor,Dhanvantri OPD Block, SMS Medical college Jaipur
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  USG guided PENG block (Ropivacaine)  Patients will receive ultrasound guided Pericapsular Nerve Group Block with 20ml of 0.5% Ropivacaine( 13ml of 0.75% Ropivacaine+ 7ml Normal saline) and 1ml of Normal saline.NRS score will be assessed at an interval of 1 minute,upto 20 minutes until NRS less than 3.This time will be noted. In the postopertive period, the analgesic efficacy will be assessed at various intervals for 24 hours.  
Intervention  USG guided PENG block(Ropivacaine with Dexamethasone)  Patients will receive ultrasound guided Pericapsular Nerve Group Block with 20ml of 0.5% Ropivacaine( 13ml of 0.75% Ropivacaine+ 7ml Normal saline) and 1ml(4mg) of Dexamethasone.NRS score will be assessed at an interval of 1 minute,upto 20 minutes until NRS less than 3.This time will be noted. In the postopertive period, the analgesic efficacy will be assessed at various intervals for 24 hours. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient undergoing elective surgery for hip fracture under spinal anesthesia.
Patients consenting to participate.
Adult patients.
Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.
 
 
ExclusionCriteria 
Details  Patients participating in other study
Uncooperative patients
Patients with psychiatric illness
Patients with peripheral sensorineural deficit.
Patients allergic to local anesthetics.
Infection at the site of block
Patients with contraindications to regional anaesthesia.
Patients with suspected compartment syndrome in lower limbs.
 
 
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 asses and compare NRS after giving PENG block between both the groups before positioning for spinal anesthesia.
2.To asses and compare total duration of analgesia between both the groups.
 
1.To asses and compare Numerical rating scale (NRS) score in postoperative period at 30minute,1,2,4,6,12,18, and 24 hr. between both the groups
2.To determine the difference in mean dose of analgesic required for 24 hours in both groups.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine the change in the hemodynamic parameters (HR, SBP, DBP, MAP and SpO2) in both groups.
2.To assess and compare patient satisfaction using Three-Point Likert Rating Scale between both groups.
 
1.To determine the change in the hemodynamic parameters (HR, SBP, DBP, MAP and SpO2) in both groups at hourly intervals till 6hrs and 2 hrly intervals till 24 hrs.
2.To assess and compare patient satisfaction after 24 hrs. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/07/2024 
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 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  
Hip fractures are common orthopedic problems associated with significant morbidity and
mortality. As a definitive treatment, most patients with fractured hips would undergo early
reduction and surgical fixation (1). 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 adult population (2). Irrespective of the etiology, hip fractures are a
painful condition, and early pain relief and definitive management is of utmost importance,
especially in the elderly population.
Hip surgery is often accompanied by severe pain-induced postoperative adverse effects, such
as enhanced blood pressure, delayed mobility, delirium, and deep vein thrombosis. As a
result, patients require large opioid doses for pain relief, which, in turn, induce drug-related
complications like nausea, vomiting, itching, and respiratory inhibition, which are not
conducive to patient recovery. (3)
Central neuraxial blockade is the most common anaesthetic technique for hip surgical
procedures. Patients with hip fracture experience excruciating pain, which would prevent the
ideal positioning of the patient for the neuraxial blockade . (4) There is growing interest in using
regional nerve blocks for pain reduction in the elderly with fractured hip. Femoral nerve
block (FN), Fascia Iliaca block (FIB), and 3-in-1 FN block were formerly used to treat hip
fractures. These blocks provided perioperative analgesia and reduced the patient’s
postoperative opioid requirement . (5) Although FNB and FICB provides adequate analgesia for
patients, it has certain limitations, such as incomplete block and lower limb muscle weakness.
The anterior capsule of the hip joint is mainly supplied by branches of the femoral nerve
(FN), obturator nerve (ON), and accessory obturator nerve (AON). Literature suggests that
the obturator nerve is not covered in these blocks. The core of hip analgesia is the anterior
capsule, and FN, ON, and AON are the keys to block (6) PENG, a new regional block
technique introduced by Girón Arango et al. (7) in 2018.Available evidence suggests that the
PENG block has shown some promise in cases undergoing hip surgery . (8) We have planned
this study to compare the pre operative and post operative analgesic efficacy of USG guided
PENG block with Ropivacaine vs Ropivacaine with Dexamethasone for elective hip surgery.
 
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