| 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 |
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Scientific Title of Study
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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 |
|
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Primary Sponsor
|
| Name |
Department of Anaesthesiology VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES |
| Address |
BALLARI -583104 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONALETHICSCOMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
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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, |
|
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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 |
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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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 |
|
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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 |
|
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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" |
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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 |
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Publication Details
|
N/A |
|
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
|
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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