FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034895 [Registered on: 15/07/2021] Trial Registered Prospectively
Last Modified On: 14/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of pain relief between ultrasound guided continuous pericapsular nerve group block and lumbar plexus block after undergoing surgery for unilateral hip fracture. 
Scientific Title of Study   Continuous ultrasound Pericapsular nerve group block in comparison with ultrasound lumbar plexus block for postoperative pain Management in unilateral hip fracture: A Prospective, randomised, single blind controlled trial study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pelerieto Rurhia 
Designation  Post Graduate Junior Resident 
Affiliation  GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH 
Address  Department of Anaesthesia and Intensive Care GMCH Chandigarh
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  07005859684  
Fax    
Email  pelerieto007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Sukanya Mitra 
Designation  Professor and Head 
Affiliation  GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH 
Address  Department of Anaesthesia and Intensive Care GMCH Chandigarh
Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Sukanya Mitra 
Designation  Professor and Head 
Affiliation  GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH 
Address  Department of Anaesthesia and Intensive Care GMCH Chandigarh
Sector 32 Chandigarh

CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital Chandigarh 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Department of Anaesthesia and Intensive care Level 5 D block Government Medical College and Hospital  
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 Pelerieto Rurhia  Government Medical College and Hospital  Department of Anaesthesia and Intensive Care GMCH Chandigarh
Chandigarh
CHANDIGARH 
07005859684

pelerieto007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  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:S798||Other specified injuries of hip and thigh. Ayurveda Condition: Not Applicable,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Analgesic efficacy of continuous ultrasound lumbar plexus block for unilateral hip fracture surgery.  Patient will be given 0.5% of Ropivacaine (15 ml bolus) plus 2 microgram/ml fentanyl will be injected and the infiltration visualised on the screen simultaneously. The nerve root also gets delineated better after the injection of the local anaesthetic. Stimulus will be applied on patient’s skin by applying cold touch and needle prick over contralateral thigh and then on the thigh of the operative side to compare both the responses. Confirmation will be done by eliciting the absence of response to pin prick and moist cotton wisp touch. In the postoperative period all patients will receive continuous background infusion of 5 ml/h of 0.2% of ropivacaine with 2 μg/ml of fentanyl. 
Intervention  Analgesic efficacy of continuous ultrasound pericapsular nerve group block for unilateral hip fracture surgery.  Patient will be given 0.5% of Ropivacaine (15 ml bolus) plus 2 microgram/ml fentanyl will be injected. A catheter will be inserted 3 cm beyond the needle tip, and an injection/aspiration test with saline will be performed. The success of the block will be assessed by pain scores at rest and on dynamic movement of hip (straight leg raise to 150 , assessment of Quadriceps strength. Block onset time is around 30 minutes and sufficient time needs to elapse before block testing. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  America Society of Anaesthesiologists (ASA) status - I and II
Age between 20 - 80 years
BMI - 18 - 35 kg/m2
Patients undergoing surgery for unilateral hip fracture 
 
ExclusionCriteria 
Details  Patient refusal
History of drug allergy to ropivacaine and fentanyl
Coagulation disorders
Cardiovascular, respiratory, and neurological illness
Uncontrolled Diabetes Mellitus
Local infection
Systemic infection
Aberrant anatomy of the landmarks
Patients having haemodynamic instability
Pregnancy and lactating mother
Patients who fail to understand pain assessment and usage of PCA pump 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the mean postoperative pain score over 48 hours using numeric rating scale in patients receiving PENG block vs lumbar plexus block  5 mins, 10 mins, 15 mins, 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the difference in motor power and patient satisfaction within the two groups and also note adverse effects, if any, in both groups  5 mins, 10 mins, 20 mins, 4 hours, at 2 hour intervals till 24 hours, 36 hours, and 48 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   03/08/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The postoperative pain relief of the patients undergoing surgery for unilateral hip fracture can be done by various techniques. Multiple trials and a systematic review have described decrease in pain scores and opioid consumption while comparing postoperative regional analgesia to systemic analgesia. Regional anaesthesia is considered one of the safer modes in elderly patients to alleviate postoperative morbidity and mortality. Lumbar plexus block (psoas compartment block) under ultrasound guidance is a novel important modality for providing pain relief in hip fracture surgeries. One of the difficulties of effective regional analgesia of hip pain is the complex innervation of the joint. Sensory innervation of anterior capsule of hip includes articular branches of femoral, obturator and accessory obturator nerve, with a greater contribution by the high branches of femoral nerve. Pericapsular nerve group block (PENG) is a novel regional analgesia technique for postoperative pain management of hip fracture. It was first described (PENG) block in 2018 by using a low frequency curvilinear ultrasound probe to deposit local anaesthetic in the 2 musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. It was successfully demonstrated that PENG block reduced pain score by a median of 7 points on a 10 points numerical rating scale in patients with hip fracture. PENG block is primarily ultrasound guided which targets the articular branches of femoral nerve, accessory obturator nerve. PENG block is also used for surgical anaesthesia to reduce dislocated hip, striping of varicose vein. The major limiting factor for PENG block is the use of ultrasound as it is not yet available to everyone particularly in developing countries. The present study aims to evaluate the effectiveness, efficacy and safety of PENG block in comparison with lumbar plexus block for postoperative pain management of hip fracture.
 
Close