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CTRI Number  CTRI/2024/04/065755 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Evaluation of Post-Operative Analgesic Efficacy of two different drug volumes of same concentration of local anesthetic in patients undergoing hip fracture surgery under ultrasound guided Pericapsular Nerve Group Block around the hip joint 
Scientific Title of Study   Comparative Evaluation of Post-Operative Analgesic Efficacy of 15 ml of 0.375 % Ropivacaine versus 25 ml of 0.375 % Ropivacaine in patients undergoing hip fracture surgery under ultrasound guided Pericapsular Nerve Group Block: A Prospective Randomised Double Blinded 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  Aruna Bharti 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow 
Address  Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow UTTAR PRADESH India

Lucknow
UTTAR PRADESH
226014
India 
Phone  9140225377  
Fax    
Email  cardarone@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sonam Pandey 
Designation  Junior Resident 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow 
Address  Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow UTTAR PRADESH India

Lucknow
UTTAR PRADESH
226014
India 
Phone  7080635906  
Fax    
Email  drsonam.2013@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonam Pandey 
Designation  Junior Resident 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow 
Address  Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow UTTAR PRADESH India

Lucknow
UTTAR PRADESH
226014
India 
Phone  7080635906  
Fax    
Email  drsonam.2013@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institute of Medical Sciences  
 
Primary Sponsor  
Name  Aruna Bharti 
Address  Department Of Anaesthesiology , SGPGIMS, Lucknow 
Type of Sponsor  Other [self] 
 
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 Sonam Pandey  Apex trauma centre, SGPGI  Operation Theatre, Department of Anesthesiology,Apex Trauma Centre, SGPGI
Lucknow
UTTAR PRADESH 
7080635906

drsonam.2013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular Nerve Group Block  Single shot PENG BLOCK administered using 15 ml of 0.375% Ropivacaine using USG and echogenic needle over 45 seconds 
Comparator Agent  Pericapsular Nerve Group Block  Single shot PENG BLOCK administered using 25 ml of 0.375% Ropivacaine using USG and echogenic needle over 45 seconds 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patient who had given written informed consent
2. Patients belonging to ASA grade I and II.
3. All genders
4. Patients in the age group of 18 yrs and above
5. Patient with hip fracture ( fracture neck of femur, intertrochanteric and subtrochanteric fractures).
 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. ASA grade III and IV
3. Emergency surgeries
4. Patients with polytrauma
5. Patient who had allergy and intolerance to local anesthetics & have active skin infection.
6. Patient with cognitive impairment, delirium, dementia and severe hearing impairment
7. Coexisting coagulopathy or anticoagulant or antiplatelet treatment that would be a contraindication to regional anesthesia.
8. Patient having diabetes, ischemic and valvular heart disease, pre-existing neurologic deficits in the limb .
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare the Mean NRS (Numeric Rating Scale) to assess static and dynamic pain between two treatment groups  Post operative at 2,4,6,12,18,24,30,36,42 and 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. Quality of recovery at 24 & 48 hrs as measured by the QoR 15 questionnaire
2. Mean opioid consumption at 24 & 48 hrs
3. Pain score during positioning for spinal anesthesia 
upto 48 hrs
Pain during positioning at 15 mins after giving block 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/04/2024 
Date of Study Completion (India) 24/03/2025 
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  

Hip fracture is an increasingly common emergency surgical presentation particularly amongst elderly and a rising social and economic burden. This reflects the high morbidity and mortality of the condition , particularly among the frail elderly .PENG(Pericapsular Nerve Group) Block was first described by Phillip W.H. Peng in July, 2018 . PENG block is a novel regional anesthesia technique that has been proposed as an effective motor sparing block for total hip arthroplasty. PENG Block targets the articular branches of femoral ,obturator and accessory obturator nerves providing innervation to the anterior capsule of the hip joint. Its potential motor sparing effect is desirable for early ambulation , better physical therapy and earlier discharge . The potential analgesic benefit provided by this block, without impairing motor function , positively impact patient mood, sleep, appetite and over all well being. Ropivacaine is an amide local anesthetic with predilection for sensory blockade. We hypothesize that 15 ml of 0.375% ropivacaine would be able to achieve similar analgesic effects as 25ml of 0.375% ropivacaine. Studies conducted so far to assess the analgesic efficacy of PENG block have used local anaesthetic in a volume ranging from 8 to 30 ml and concentration 0.2% to 0.5% . Inclusion criteria: 1.Patient wo had given written informed consent 2.Patients belonging to  ASA grade I and II. 3.All genders 4.Patients in the age group of 18 yrs and above 5.Patient with hip fracture ( fracture neck of femur, intertrochanteric and subtrochanteric fractures). Exclusion criteria : 1.Patient refusal. 2.ASA grade III and IV 3.Emergency surgeries 4.Patient with polytrauma 5.Patient who had allergy and intolerance to local anesthetics & have active skin infection. 6.Patient with cognitive impairment, delirium, dementia and severe hearing impairment. 7.Coexisting coagulopathy or anticoagulant or antiplatelet treatment that would be a contraindication to regional anesthesia. 8.Patient having diabetes , ischemic and valvular heart disease, pre-existing  neurologic deficits in the limb . After obtaining approval from the institutional ethics committee of SGPGIMS and written informed consent from the patients, the study will be conducted with the study population being the patients undergoing surgery for hip fracture. Patients will be randomly allocated by use of block randomization method using software ‘Sealed Envelope”.The duration of study is going to be for about 18 months.  Subjects will be placed in supine position,standard ASA monitors will be applied, oxygen will be administered via nasal cannula. Intravenous midazolam and fentanyl will be titrated for patient comfort. After skin disinfection and draping, a curvilinear low frequency probe (2-5 Hz) will be initially placed in a transverse plane over the anterior inferior iliac spine ,before being aligned with the pubic ramus by rotating the probe 45 degree counterclockwise .The skin puncture site will be anesthetized using 2% lignocaine (2-3 ml ) A 22G 100 mm echogenic needle(Pajunk or Stimuplex needle) will be inserted from lateral to medial in an in- plane approach and will be advanced to the target site i.e. between the psoas tendon anteriorly and pubis ramus posteriorly .In group A, 15 ml of 0.375 % Ropivacaine will be injected and in group B,  25 ml of 0.375% ropivacaine will be injected to the target site. In both the groups , 4 mg of injection dexamethasone will be administered intravenous at the time of block placement .[8 Negative aspiration should be observed before injection of local anesthetic into the plane and observation of fluid spread in the desired plane. Pain during positioning(i.e. sitting position or Hamstring stretch position) for spinal anesthesia will be assessed using the pain score (score 0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of restlessness or agitation). 30 minutes after placement of Pericapsular Nerve Group Block, spinal anesthesia will be administered using 0.5 % hyperbaric bupivacaine with a dose range of 12-15 mg based on patient height along with 15 mcg of fentanyl. Patients in both the groups will receive same care pre and postoperatively. Post operatively subjects in both the groups will receive scheduled paracetamol (15 mg/kg) six hourly as part of a multimodal pain regimen. Static and dynamic pain assessment will be done at 2h, 4h, 12h, 18h, 24h,30h, 36 h,42h, 48h, using NRS. NRS score more than 4 will be treated as breakthrough pain and injection fentanyl  (0.5 mcg/kg) will be administered intravenous as rescue analgesic. Time at which first rescue analgesia is demanded by the patient will also be recorded.

 

 

 
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