| CTRI Number |
CTRI/2025/12/098352 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison Of Dexmedetomidine And Dexamethasone As Adjuvant To Ropivacaine In Ultrasound-Guided Erector Spinae Plane Block For Elective Unilateral Open Inguinal Hernia Repair Under Spinal Anaesthesia: A Prospective Randomised Double Blind Study.” |
|
Scientific Title of Study
|
“Comparison Of Dexmedetomidine And Dexamethasone As
Adjuvant To Ropivacaine In Ultrasound-Guided Erector Spinae
Plane Block For Elective Unilateral Open Inguinal Hernia Repair
Under Spinal Anaesthesia: A Prospective Randomised Double
Blind Study.”
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Redapangu Jhansi |
| Designation |
Post graduate |
| Affiliation |
Government Medical College |
| Address |
Room NO -200, Department Of Anaesthesiology ,Government Medical College , Putlampalli Road ,Cuddapah.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09705028243 |
| Fax |
|
| Email |
jhansi.redapangu.47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Lakshmi Praveena |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College |
| Address |
Department Of Anaesthesiology ,Government Medical College , Putlampalli Road, Cuddapah.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9494677784 |
| Fax |
|
| Email |
praveenadoc4all@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr Redapangu jhansi |
| Designation |
Post graduate |
| Affiliation |
Government Medical College |
| Address |
Department Of Anaesthesiology ,Government Medical College , Putlampalli Road ,Cuddapah.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9494677784 |
| Fax |
|
| Email |
jhansi.redapangu.47@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology ,Government Medical College , Putlampalli Road ,Cuddapah. |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology Government Medical College |
| Address |
Government medical college kadapa |
| 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 Redapangu Jhansi |
Government General hospital |
Room No -200, Department Of Anaesthesiology ,Government Medical College , Putlampalli Road ,Cuddapah.
Cuddapah
ANDHRA PRADESH |
09705028243
jhansi.redapangu.47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe government medical college kadapa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with hernia posted for hernioplasty |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae block with Ropivacaine and Dexamethasone |
to compare VAS score, duration of analgesia, rescue analgesics between two groups |
| Intervention |
Erector spinae block with Ropivacaine and Dexmedetomidine |
to compare VAS score, duration of analgesia, rescue analgesics between two groups |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
PATIENTS IN THE AGE OF 18 TO 60 YEARS MALE PATIENTS POSTED FOR OPEN INGUINAL HERNIA REPAIR |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathies, bleeding diathesis, on anticoagulants,chronic pain treatment and cognitive deficit
Patients with known hypersensitivity to study drugs.
Patients with infection at the puncture site. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
To compare postoperative pain using visual analogue scale (VAS) between the two groups.
|
at 30min,1hr,4hrs,10hrs, 16hrs, 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.To compare the duration of analgesia between the two groups
3.To compare the need for rescue analgesia & total analgesic requirement in 24 hours in both groups.
4.To compare the adverse effects in both groups
|
at 30min,1hr,4hrs,10hrs,16hrs,24hrs. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="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
|
a study titled “Comparison of Dexmedetomidine and Dexamethasone as adjuvant to Ropivacaine in ultrasound-guided erector spinae plane block for elective unilateral open inguinal hernia repair under spinal anaesthesia: a prospective randomised double blind study” will be carried out in gmc. this study included 100 male patients aged between 18 to 60 years randomly divided into two groups of 50 patients each scheduled for unilateral open inguinal hernia repair under spinal anaesthesia receiving thoracic esp block. group a patients will receive 18 ml of 0.375% ropivacaine plus 0.5µg/kg of dexmedetomidine diluted in 2ml of normal saline (total 20ml) where as in group b patients will receive 18 ml of 0.375% ropivacaine plus 4 mg of dexamethasone diluted in 2ml of normal saline (total 20ml). parameters such as comparison of vas scores between 2 groups, total duration of analgesia, total rescue analgesic consumption in 24 hours and adverse events like nausea, vomiting sedation bradycardia will be noted in our study.
|