| CTRI Number |
CTRI/2023/08/056477 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Epidural Anaesthesia and ultrasound guided Hernia block, comparing the haemodynamic stability and adequasy of anaesthesia in geriatric population undergoing inguinal hernia repair using ropivacaine - A one year randomized control trial |
|
Scientific Title of Study
|
Comparing the effects of Epidural Anaesthesia and ultrasound guided Hernia block on haemodynamic changes in geriatric patients undergoing inguinal hernia repair using ropivacaine - A one year randomized control trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T G Neha Sunil |
| Designation |
Resident in Anesthesiology |
| Affiliation |
Jawaharlal Nehru institute of medical sciences |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Institute of
Medical Sciences, Nehru Nagar, Belgavi-590010 Belgaum
Karnataka 590010 India
Belgaum
nehru nagar, jnmc, belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9000600234 |
| Fax |
|
| Email |
nehatgsunil@icloud.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedareshvara KS |
| Designation |
Professor Anaesthesiology |
| Affiliation |
Jawaharlal Nehru institute of medical sciences |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Institute of
Medical Sciences, Nehru Nagar, Belgavi-590010 Belgaum
Karnataka 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886375154 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kedareshvara KS |
| Designation |
Professor Anaesthesiology |
| Affiliation |
Jawaharlal Nehru institute of medical sciences |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Institute of
Medical Sciences, Nehru Nagar, Belgavi-590010 Belgaum
Karnataka 590010 India
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9886375154 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belgavi, Karnataka, 590010
India |
|
|
Primary Sponsor
|
| Name |
T G Neha Sunil |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Institute of
Medical Sciences, Nehru Nagar, Belgavi-590010 Belgaum
Karnataka 590010 India
Belgaum |
| 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 |
| T G Neha Sunil |
KLE Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesia, Jawaharlal Nehru Institute of
Medical Sciences, Nehru Nagar, Belgavi-590010 Belgaum
Karnataka 590010 India
Belgaum
KARNATAKA |
9000600234
nehatgsunil@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
group 1- epidural anesthesia
|
epidural analgesia with 0.75% ropivacaine
Heart rate, BP(SBP,DBP,MAP) Spo2 measured at
5 MIN
10 MIN
15 MIN
20 MIN
30 MIN
40 MIN
50 MIN
60 MIN
75 MIN
90 MIN
105 MIN
120 MIN
|
| Intervention |
hernia block |
ilioinguinal and iliohypogastric nerve block using equal mixture of 10 mL of 2% lidocaine hydrochloride and 10 ml of 0.75% ropivacaine
genitofemoral nerve block using an equal mixture of 5ml of 0.75% ropivacaine and 5ml of 2% lignocaine
Heart rate, BP (SBP, DBP, MAP), Spo2 measured at
5 MIN
10 MIN
15 MIN
20 MIN
30 MIN
40 MIN
50 MIN
60 MIN
75 MIN
90 MIN
105 MIN
120 MIN
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade II onwards
Posted for primary inguinal hernia repair patients with uncomplicated hernia
Patients who give written informed consent
Patients with ejection fraction more than 45%
|
|
| ExclusionCriteria |
| Details |
Patient with local infection
Patients with strangulated hernia, irreducible hernia, recurrent hernia
Patients with medical history of allergy to local anesthetics
Patients with bleeding disorders
Drug allergy to ropivacaine
Patients with contraindication to epidural anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the haemodynamic changes in hernia block & epidural anaesthesia in geriatric patients undergoing inguinal hernia repair |
0min, 5min, 10min, 15min, 25min, 35min, 45min, 55min, 70min, 95min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra operative comfort in hernia block & epidural anesthesia in geriatric patients |
0min, 5min, 10min, 15min, 25min, 35min, 45min, 55min, 70min, 95min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
24/08/2023 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Inguinal hernia repair is one of the most commonly performed surgical procedures every year. The choice of anesthetic techniques ranges from local infiltration to regional block to general anesthesia. The presence of comorbidities like Hypertension, Diabetes Mellitus, and ischemic heart disease may pose a challenge to intraoperative management in geriatric age group. Epidural anesthesia carries an advantage over spinal anesthesia with regard to degree of hemodynamic variability. Hernia block holds the advantage of maintaining hemodynamics of the patient. Hence we make an attempt to compare the two using ropivacaine. |