| CTRI Number |
CTRI/2026/02/102761 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Dexamethasone and Magnesium Sulphate as adjuvant to Ropivacaine in Ilioinguinal Iliohypogatsric block for postoperative pain relief in lower abdominal surgeries performed under general anaesthesia |
|
Scientific Title of Study
|
A prospective randomized comparative study of dexamethasone versus magnesium sulphate as an adjuvant to ropivacaine in ilioinguinal iliohypogastric block in lower abdominal surgeries under general anaesthesia. |
| 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 Shivangi Gupta |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut, Uttar Pradesh India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9971932884 |
| Fax |
|
| Email |
drshivangi048@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta |
| Designation |
Associate Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweta |
| Designation |
Associate Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical
College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM medical college meerut 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical College |
| Address |
Department of Anaesthesia, LLRM Medical College, Meerut, Uttar
Pradesh 250004 |
| Type of Sponsor |
Government medical college |
|
|
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 Shivangi Gupta |
LLRM medical college meerut |
Department of
Anaesthesia LLRM
Medical College Meerut
uttar pradesh
Meerut
UTTAR PRADESH |
9971932884
drshivangi048@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: O342||Maternal care due to uterine scarfrom previous surgery, (4) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, (5) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ilioinguinal Iliohypogastric block |
Drug is administered perineurally around Ilioinguinal Iliohypogastric nerves
in all the participants of the
study. We observe patient for
24 hours post operatively |
| Comparator Agent |
Inj. Ropivacaine with
Inj. Dexamethasone |
Inj Ropivacaine (0.375%) 15ml with 4mg Dexamethasone diluted with normal saline to 16ml given on both sides around Ilioinguinal Iliohypogastric nerves |
| Comparator Agent |
Inj. Ropivacaine with Inj. Magnesium Sulphate |
Inj Ropivacaine (0.375%) 15ml with 250mg Magnesium Sulphate diluted with normal saline to 16ml given on both sides around Ilioinguinal Iliohypogastric nerves |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 And 2
Age 18-65 Yrs
Sex Male and Female
BMI 18 to 25 kg per sq metre
Patients Undergoing lower abdominal surgeries under General Anaesthesia
Patients with informed consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
Infection at injection site
Coagulopathy
Significant cardiopulmonary diseases, hepatic and renal dysfunction
Chronic alcohol or narcotic drug abuse
Peripheral neuropathy
Known allergy or hypersensitivity to study drug
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the efficacy and the
quality of post operative analgesia. |
Postoperatively pain will be assessed at different
time intervals for initial 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timing of requiring first dose of rescue analgesic |
Patient to be assessed for 24 hours post
operatively |
| Total analgesic consumption in 24 hours |
Patient to be assessed for 24 hours post
operatively |
| Assess hemodynamic changes |
Patient to be assessed for 24 hours post
operatively |
| Post operative Quality of Recovery Score |
Patient to be assessed for 24 hours post
operatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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 Yet Recruiting |
| 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
|
This is a prospective randomised comparative evaluation of postoperative analgesia achieved with Ilioinguinal Iliohypogastric block using Ropivacaine with Dexamethasone versus Ropivacaine with Magnesium Sulphate in lower abdominal surgeries performed under general anaesthesia.Also will be assessing the timing of requiring first dose of rescue analgesic, total dose of rescue analgesia required in 24 hours, hemodynamic changes, Quality of Recovery Score assessment and complications if any during post operative period. |