| CTRI Number |
CTRI/2024/04/066048 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| 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
|
Regional Block for Inguinal Hernia Surgery |
|
Scientific Title of Study
|
Analgesic efficacy of Dexmedetomidine versus Magnesium Sulfate as an adjuvant to Ropivacaine in Ilioinguinal and Iliohypogastric nerve block for unilateral Open Inguinal Hernia Repair under Spinal Anaesthesia: A Randomized Controlled Trial |
| 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 Bodigandla Reddi Gireesh |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9966773856 |
| Fax |
|
| Email |
2387005@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxman Kumar Senapati |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7325919472 |
| Fax |
|
| Email |
laxman.senapati@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxman Kumar Senapati |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7325919472 |
| Fax |
|
| Email |
laxman.senapati@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Bodigandla Reddi Gireesh |
| Address |
Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar, Odisha 751024 |
| 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 Laxman Kumar Senapati |
Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences |
Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
7325919472
laxman.senapati@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40||Inguinal hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG guided Ilioinguinal and Iliohypogastric (IIIH) nerve block |
Group 1- IIIH block with 10 ml of 0.5% Ropivacaine |
| Intervention |
USG guided Ilioinguinal and Iliohypogastric (IIIH) nerve block |
Group 2- IIIH Block with 10 ml of 0.5% Ropivacaine plus 5 mg/kg of MgSO4
|
| Intervention |
USG guided Ilioinguinal and Iliohypogastric (IIIH) nerve block |
Group 3- IIIH Block with 10 ml of 0.5% Ropivacaine plus 1 mcg/kg of Dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for unilateral inguinal hernia repair under spinal anaesthesia,
2. Age 18-60 years,
3. American Society of Anesthesiologists (ASA) physical status I-III. |
|
| ExclusionCriteria |
| Details |
1. Contraindication to peripheral nerve blocks
2. Pre-existing neuropathy
3. Coagulopathy
4. BMI ≥ 35 kg/m²
5. Chronic use of analgesics
6. Patients with cognitive impairment |
|
|
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 |
| Time to the requirement of first dose of rescue analgesic |
in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total opioid consumption (‘morphine equivalents in milligrams’) in postoperative period,
2. Intraoperative- Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and, SpO2 every 5 minutes for the first 30 minutes of surgery and then every 15 minutes till the end of surgery,
3. Postoperative- Modified Ramsay Sedation Scale score at 0, 3rd, 6th, 12th and 24th hour,
4. Postoperative- Visual Analogue Scale (VAS) score at 0, 3rd, 6th, 12th and 24th hour,
5. Incidence of adverse effects like nausea, vomiting, hypotension, bradycardia, hematoma.
|
VAS score and modified Ramsay sedation Scale score at 0, 3rd, 6th, 12th and 24th hour |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="2"
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
|
Inguinal hernia repair is usually done under spinal anaesthesia. Regional anaesthesia technique (IIIH block) provides pain relief for longer duration after the surgery, which will lead to early discharge from the hospital and also decreases the risk of developing chronic post-surgical herniorrhaphy in the long term. So, we want to compare the effect of adding dexmedetomidine or magnesium sulfate to this block to provide better and longer duration of pain relief without the side effects of usual pain medications like opioids.
|