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CTRI Number  CTRI/2024/06/068519 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
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   Ultrasound guided(USG) pericapsular nerve group block (PENG) using 0.25% Bupivaicaine with or without magnesium sulphate for positional comfort during regional block in hip fracture patients 
Scientific Title of Study   A Randomized comparative study of ultrasound guided(USG) pericapsular nerve group block (PENG) using 0.25% Bupivaicaine with or without magnesium sulphate for positional comfort during neuraxial block in hip fracture patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARSHITHA SHRI U R 
Designation  Post graduate in Anaesthesiology 
Affiliation  Vijayanagar Institute Of Medical Sciences , Ballari 
Address  Department of Anesthesiology and critical care, Vijayanagar Institute Of Medical Sciences , Ballari
Same as Above
Bellary
KARNATAKA
583104
India 
Phone  7871607201  
Fax    
Email  arshiaishu.18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ARSHITHA SHRI U R 
Designation  Post graduate in Anaesthesiology 
Affiliation  Vijayanagar Institute Of Medical Sciences , Ballari 
Address  Department of Anesthesiology and critical care, Vijayanagar Institute Of Medical Sciences , Ballari
Same as above
Bellary
KARNATAKA
583104
India 
Phone  7871607201  
Fax    
Email  arshiaishu.18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KIRAN CHAND N 
Designation  ASSOCIATE PROFESSOR 
Affiliation  vijayanagar institute of medical sciences 
Address  Department of Anaesthesiology Vijayanagar institute of Medical sciences BELLARY
same as Above
Bellary
KARNATAKA
583104
India 
Phone  9845857056  
Fax    
Email  nkiranchand@yahoo.com  
 
Source of Monetary or Material Support  
DEPT OF ANAESTHESIA Vijayanagar Institute of Medical Sciences Bellary  
 
Primary Sponsor  
Name  Department of Anaesthesiology VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES 
Address  BALLARI -583104 
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 
ARSHITHA SHRI U R  DEPARTMENT OF ANAESTHESIOLOGY ,VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES   VIMS ,BELLARY- 583104
Bellary
KARNATAKA 
7871607201

arshiaishu.18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONALETHICSCOMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (2) ICD-10 Condition: S721||Pertrochanteric fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PENG BLOCK WITH MAGNESIUM SULPHATE  PENG BLOCK given under USG guidance using 0.25% BUPIVAICAINE 18 ml WITH 2ml of 10% MAGNESIUM SULPHATE 
Comparator Agent  PENG BLOCK WITH NORMAL SALINE   PENG BLOCK given under USG guidance USING 18 ml of 0.25% bupivaicaine with 2ml of normal saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA 1 ,2 & 3
Patient with normal cardiopulmonary function 
 
ExclusionCriteria 
Details  refusal by patients
deranged coagulation profile
patient with mental, neurological , severe cardiovascular disease.
punture site infection
allergy to local anesthetics
neuromuscular diseases
history of epilepsy and alchoholism
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of reduction in PAIN using NRS(Numerical rating scale) scores following administration of PENG block IN BOTH GROUPS  COMPARING NRS PAIN SCORING 30 MINUTES AFTER PENG BLOCK IN BOTH GROUPS 
 
Secondary Outcome  
Outcome  TimePoints 
QUALITY OF PATIENT POSITIONING BY EOSP SCORE IN BOTH GROUPS  30 MINS AFTER PENG BLOCK COMPARING EOSP SCORE IN BOTH GROUPS 
TIME TAKEN FOR FIRST RESCUE ANALGESIA AFTER PENG BLOCK IN BOTH GROUPS  WITHIN 24 HRS OF PENG BLOCK 
TOTAL RESCUE ANALGESIA USED IN BOTH GROUPS  TOTAL RESCUE ANALGESIA USED IN FIRST 24 HRS AFTER PENG BLOCK IN BOTH GROUPS 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   17/06/2024 
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="1"
Months="0"
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   A Prospective Double Blinded Randomized Comparative study of Ultrasound guided (USG) Pericapsular Nerve Group Block (PENG) using ) 0.25% Bupivaicaine with or without magnesium sulphate for positional comfort during neuraxial block in Hip fracture patients.

PENG block is a newer technique using USG guidance to block femoral nerve and obturator nerve and sparing quadriceps femoris muscle. The aim of study is to compare the efficacy of PENG block with or without magnesium sulphate for  positional comfort during neuraxial block in patients of age of 18- 70 yrs scheduled for emergency / elective hip surgeries .
Thorough preoperative evaluation and neccessary investigations and informed consent of patients / relatives is taken. In preoperative room, all patients are randomly allotted to one of 2 groups, group M and group N by computer generated randomization via Research Randomizer Software ( www.randomizer.org).The allocation concealment is ensured using sequentially numbered opaque sealed envelope (SNOSE) technique.The study solutions prepared by one anaesthesiologist who will not be involved in further study.

In preoperative area , all patients will be secured with 18 G IV cannula , started ringer lactate (RL) IV fluids  and monitored for NIBP, ECG and SPO2 .  Pain during rest and pain on 30 degree passive limb elevation will be assessed by NRS ( Numerical Rating Scale).Routine preparation of anaesthesia machine and drugs will be done.

Takaing all precautions ,under aseptic conditions , a low frequency curvilinear USG probe ( 2-5 MHz) will be placed over line joining anterior superior iliac spine(ASIS)  and pubic tubercle , keeping lateral margin at ASIS and adjusted probe to get sono -anatomical view of PENG block. The needle entry point on skin is selected in such a manner that perpendicular needle entry will guide needle near target point (ilio-pubic eminence), 21 G peripheral nerve stimulator (PNS) needle is inserted to reach bony rim near ilio-pubic eminence avoiding injury to femoral nerve. In Group M 18 ml 0.25% Bupivaicaine with 2 ml 10% magnesium sulphate and in group N 18 ml of 0.25 % Bupivaicaine with 2ml of normal saline slowly injected with repeated aspirations to avoid intravascular injections.

Outcomes to be assessed after PENG BLOCK in both groups:

  • After 30 minutes pain will be reassesed at rest and 30 degree passive limb elevation by using NRS pain intensity score .
  • The comfort during sitting for spinal anaesthesia will also be assessed by EOSP(EASE OF SPINAL ANAESTHESIA) score.
  • Time taken for first rescue analgesia after PENG BLOCK.
  • Total rescue analgesia required in the first 24 hours.

The following data will be collected : Demographic parameters of the patients such as age, height , weight, body mass index , vital parameters like heart rate , respiratory rate, ECG, oxygen saturation and MAP mean arterial pressure before and after delivering analgesia . Any adverse events such as bleeding , needle kinking will also be noted. Fluid management is done as per standard fluid resuscitation guidelines. all data ( related to variables of study ) assessed , will be entered in MS EXCEL sheet , cleaned and analysed. Related categorical and numerical variables will be subjected to suitable statistical tests. The numerical variables will be assessed for uniformity of distribution , before assessing for parametric and non parametric tests.

 
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