| CTRI Number |
CTRI/2024/01/061467 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare ultrasound guided pericapsular nerve group block (PENG) & femoral nerve block for minimizing positional pain during spinal and epidural anaesthesia in hip fractures posted for surgery |
|
Scientific Title of Study
|
A double blinded prospective study comparing ultrasound guided pericapsular nerve block(PENG) & femoral nerve block for minimizing positional pain in hip fractures patients posted for surgery |
| 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 Rojalin sahoo |
| Designation |
Postgraduate resident,Department of Anaesthesia |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Room no-206,campus 2,Institute of medical science and Sum hospital; SOA university,Bhubhaneswar,Odisha
NIL
Khordha
ORISSA
751003
India |
| Phone |
8763998801 |
| Fax |
|
| Email |
drrojalinsahoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaswat pattnaik |
| Designation |
Professor and Head of Department,Anaesthesia and Critical care Medicine |
| Affiliation |
Institute of medical science and Sum hospital |
| Address |
Department of Anaesthesia,Institute of medical science and Sum hospital,Bhubaneswar,Odisha
Khordha
ORISSA
751003
India |
| Phone |
8763998801 |
| Fax |
|
| Email |
hod.anaesthesiology.ims@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rojalin sahoo |
| Designation |
Postgraduate resident,Department of Anaesthesia |
| Affiliation |
Institute of medical science and Sum hospital |
| Address |
Institute of medical science and Sum hospital,Bhubaneswar,Odisha
Khordha
ORISSA
751003
India |
| Phone |
8763998801 |
| Fax |
|
| Email |
drrojalinsahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences and SUM hospital,Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Dr Rojalin Sahoo |
| Address |
Institue of Medical Science and Sum Hospital,Bhubhaneswar,Odisha |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rojalin Sahoo |
Institute of Medical Sciences and Sum Hospitall |
Department of Anaesthesia and critical care medicine.2nd floor
Khordha
ORISSA |
8763998801
drrojalinsahoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISTITTUTIONAL ETHICS COMMITTEE,INSTITUE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FEMORAL NERVE BLOCK- The femoral nerve block anaesthetizes the femoral nerve distrubation.
|
After taking written consent from 75 patients scheduled for hip surgeries under regional anaesthesia were selected. Standard hospital protocols like medical optimization,intravenous line placement,premedication and antibiotics prophylaxis was followed.Then the patient were randomized into 2 groups and blinding was done.In the operation room monitors for non invasive blood pressure ,electrocardiogram, and pulse oximeter were attached. Pain during rest and pain on 15 degree passive limb elevation was assessed by numberic rating score (NRS).In group A patient we will give pericapsular nerve group block and in group B we will give femoral nerve block using ultrasound guided needle. Drugs used in both the group are same i.e(0.25 % Bupivacaine 20 ml)
Then after successful needle placement and block,10 min later all the patient will be again assessed by pain during rest and pain during 15 degree passive movement by numberic rating scale( NRS) and ESOP(ease of spinal positioning).Spinal anaesthesia will be performed by using Quincke’s 25 gauge spinal needle in sitting position by giving 0.5% bupivacaine heavy total volume of 3.6 ml.
After the operation ,the patient will be shifted to the post op recovery room.In postoperative period,PR,NIBP,and saturation will be recorded at regular intervals,and postoperative pain relief will be accessed by numberic rating score(NRS) immediately after surgery,then at (2,4,6,8,10,12 hrs),and then the demand for 1st dose of analgesia was recorded and complication if any.Total duration of study is 15minutes.It will be performed just once in one patient.
|
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
PENG BLOCK- Pericapsular nerve block was developed in 2018 by Giron argon et al.This block is a diffusion block on the anterior surface of the hip joint capsule,target nerve branch of this block are the articular branches of femoral nerve ,the obturator nerve and the accessory obturator nerve,leading to no quadricipital motor block.
|
After taking written consent from 75 patients scheduled for hip surgeries under regional anaesthesia were selected. Standard hospital protocols like medical optimization,intravenous line placement,premedication and antibiotics prophylaxis was followed.Then the patient were randomized into 2 groups and blinding was done.In the operation room monitors for non invasive blood pressure ,electrocardiogram, and pulse oximeter were attached. Pain during rest and pain on 15 degree passive limb elevation was assessed by numberic rating score (NRS).In group A patient we will give pericapsular nerve group block and in group B we will give femoral nerve block using ultrasound guided needle. Drugs used in both the group are same that is(0.25 % Bupivacaine 20 ml)
Then after successful needle placement and block,10 min later all the patient will be again assessed by pain during rest and pain during 15 degree passive movement by numberic rating scale( NRS) and ESOP(ease of spinal positioning).Spinal anaesthesia will be performed by using Quincke’s 25 gauge spinal needle in sitting position by giving 0.5% bupivacaine heavy total volume of 3.6 ml.
After the operation ,the patient will be shifted to the post op recovery room.In postoperative period,PR,NIBP,and saturation will be recorded at regular intervals,and postoperative pain relief will be accessed by numberic rating score(NRS) immediately after surgery,then at (2,4,6,8,10,12 hrs),and then the demand for 1st dose of analgesia was recorded and complication if any.Total duration of intervention is 15 min.It will be performed just once in one patient.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-70yrs
Patients under ASA I and ASA II
Patients undergoing hip surgery who have pain and difficulty in positioning during spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
patients refusal to participate in the study
patients taking anticoagulants
Have an allergy or contraindication to the drug
Have multiple trauma
Have infection near the block site
Have clinically significant neurological,cardiovascular,renal or hepatic disease.
ASA III-V patients
patients undergoing hip surgery who can sit properly without complaining any pain for spinal anaesthesia. |
|
|
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 |
| PRIMARY OUTCOME- To compare pericapsular nerve block & femoral nerve block for relieving positional pain during regional anaesthesia in hip fractures. |
5 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SECONDARY OUTCOME-The secondary outcome in the study is to provide postoperative pain relief in hip surgery by giving preoperative nerve block (pericapsular nerve block & femoral nerve block)and comparing the efficacy of both. |
12 hrs |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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="6"
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
|
The primary objective of the study is to compare Pericapsular nerve block and the femoral nerve block for relieving positional pain during regional anaesthesia in hip fracture. Secondary objective is to provide post-operative pain relief in hip surgery. After taking written consent from 75 patients Scheduled for hip surgery under regional anaesthesia were selected. standard Hospital protocols like medical optimisation, intravenous line placement , pre-medication and antibiotic prophylaxis was followed. Then the patient were randomised into two groups and blinding was done. In the operation room monitors for non-invasive BP ,electro cardiogram and pulse oximeter were attached. Pain during rest and pain on 15 degree passive limb elevation was assessed by numeric rating score. In group a patient we will give pericapsular nerve block and in group we will give femoral nerve block using ultrasound guided needle . Drugs used in both the group are same that is 0.25% Bupivacaine 20 ML. after the operation patient will be shifted to post op recovery room. In post-operative period, pulse rate, NIBP, and saturation will be recorded at regular intervals and post-operative pain. Relief will be assessed by numeric rating scoring immediately after surgery then at(2,4,6,8,10,12 hrs), and then the demand for first dose of analgesia was recorded and complication if any.
|