| CTRI Number |
CTRI/2025/02/080846 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| 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
|
Comparative study for effectiveness of pain between dexmedetomidine or magnesium sulphate with ropivicaine in quadratus lumborum block for laparoscopic repair of inguinal hernia. |
|
Scientific Title of Study
|
Comparative study of analgesic efficacy between
addition of dexmedetomidine or magnesium sulphate with
Ropivicaine in Quadratus lumborum block for endoscopic
Inguinal Hernia Repair. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Keshav Ram S |
| Designation |
Junior Resident |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09841155955 |
| Fax |
|
| Email |
drkeshav0706@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Kumar Paswan |
| Designation |
Professor |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09794855871 |
| Fax |
|
| Email |
dranil1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Kumar Paswan |
| Designation |
Professor |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09794855871 |
| Fax |
|
| Email |
dranil1973@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pain and Palliative medicine, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi- 221005 ,India. |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Pain and Palliative medicine, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Keshav Ram S |
Banaras Hindu University, Institute Of Medical Sciences_ethics committee |
Department of Pain and Palliative medicine, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH |
9176608733
drkeshav0706@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University, Institute Of Medical Sciences_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 |
Control Group |
After proper positioning of the needle tip which will be confirmed by hydrodissection,Ultrasound guided QL2 block with 30ml of Inj.Ropivicaine 0.375% would be administered. |
| Intervention |
Quadratus Lumborum Block |
A high frequency linear ultrasound probe will be placed in the axial plane in the midaxillary line to visualize the expected three
abdominal layers (transversus abdominis, external oblique, and internal oblique). The probe will be moved osteriorly until the QL was confirmed. The posterior aspect of the QL would be identified. The skin would be prepped using standard aseptic
technique, and the needle inserted and advanced to the posterior aspect of the QL muscle. |
| Comparator Agent |
ROPIVICAINE WITH MAGNESIUM SULPHATE /DEXMEDETOMIDINE INJECTION |
After Proper positioning of the needle tip which will be
confirmed by hydrodissection, 30 mL of 0.375% ropivacaine with Magnesium sulphate 400mg / Dexmedetomidine 50mcg would be administered |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Both |
| Details |
-Patients having uncomplicated inguinal hernia
-Age more than 18- 56 years.
-American society of Anaesthesiologists grade I and II patients
-Written and informed consent |
|
| ExclusionCriteria |
| Details |
-Patient with known coagulopathy.
-Patients allergic to the study drug.
-Patients with hepatic or renal dysfunction.
-Patients with history of receiving anticoagulant treatment.
-Patients having history of chronic opioid consumption. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score will be monitored |
Post procedure outcomes are assesed at 0min, 15 minutes, 1 hour, 2 hours,6hours, 12 hours, 24 hours post-operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for requirement of first rescue analgesia will be noted. |
Post procedure rescue analgesia assesed till 24 hours |
|
|
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)
|
27/02/2025 |
| 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
|
After obtaining the institutional ethical committee approval and written informed consent from the participants, they will be enrolled into our study. A total of 90 participants will be enrolled and randomized into two equal groups of 30 each.
Group A (ROPIVICAINE WITH MAGNESIUM SULPHATE): Ultrasound guided QL2 block with 30ml of Inj. Ropivacaine 0.375% +Inj .Magnesium sulphate 400mg
Group B (ROPIVICAINE WITH DEXMEDETOMIDINE): Ultrasound guided QL2 block with 30ml of Inj. Ropivacaine 0.375% + Inj.Dexmedetomidine 50mcg
CONTROL GROUP C (ROPIVICAINE): Ultrasound guided QL2 block with 30ml of Inj.Ropivicaine 0.375% |