| CTRI Number |
CTRI/2025/10/095633 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Pain Relief After Breast Augmentation Surgeries Using Ultrasound Guided Nerve Block With Ropivacaine Combined Either With Dexmedetomidine Or With Nalbuphine. |
|
Scientific Title of Study
|
Comparison Of Postoperative Analgesic Efficacy Of 0.5 Percentage Ropivacaine With Dexmedetomidine Versus 0.5 Percentage Ropivacaine With Nalbuphine In Ultrasound Guided Erector Spinae Plane Block For Breast Augmentation Surgeries
A Prospective Randomized Double Blinded Study |
| Trial Acronym |
NIIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Asjad T |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical Collgege And Research Institute. |
| Address |
Department of anaesthesiology
2nd floor , Hospital block
Shri Sathya Sai medical college and research institute , Ammapettai , Nellikuppam , Kancheepuram Dist
Department of anaesthesiology
2nd floor , Hospital block
Shri Sathya Sai medical college and research institute , Ammapettai , Nellikuppam , Kancheepuram Dist
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894967243 |
| Fax |
|
| Email |
drasjad97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balasubramanian Anusha |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical Collgege And Research Institute. |
| Address |
Department of Anaesthesiology
2nd floor , hospital block ,
Shri Sathya Sai medical college , Ammapettai , Nellikuppam , Kancheepuram Dist
Department of Anaesthesiology
2nd floor , hospital block ,
Shri Sathya Sai medical college , Ammapettai , Nellikuppam , Kancheepuram Dist
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894967243 |
| Fax |
|
| Email |
drasjad97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Asjad T |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical Collgege And Research Institute. |
| Address |
Department of anaesthesiology
2nd floor , Hospital block
Shri Sathya Sai medical college and research institute , Ammapettai , Nellikuppam , Kancheepuram Dist
Department of anaesthesiology
2nd floor , Hospital block
Shri Sathya Sai medical college and research institute , Ammapettai , Nellikuppam , Kancheepuram Dist
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894967243 |
| Fax |
|
| Email |
drasjad97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai medical college and reasearch institute , Ammapettai , Nellikuppam , Kancheepuram dist ,Tamil Nadu , India 603108 |
|
|
Primary Sponsor
|
| Name |
Mohammed Asjad T |
| Address |
Shri Sathya Sai medical college and research institute , Ammapettai , Nellikuppam ,kancheepuram Dist 603108 |
| 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 |
| Mohammed Asjad T |
Shri Sathya Sai Medical College and Research Institute |
Department of Anaesthesiology , 2nd floor , Hospital block Shri Sathya Sai Medical College
and Research Institute
Ammapettai Kancheepuram Tamilnadu 603108
Kancheepuram
TAMIL NADU |
989496743
drasjad97@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 |
| Healthy Human Volunteers |
ASA 1 And 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ropivacaine with Dexmedetomidine and
Ropivacaine with Nalbuphine |
Drug Ropivacaine 0.5% + Dexmedetomidine 1 mcg per kg
Route Ultrasound guided ESP block at level of T3.
Total Volume 35 ml
Drug Ropivacaine 0.5 percentage + Nalbuphine 10 mg per kg.
Route Ultrasound guided ESP block at level of T3.
Total Volume 35 ml
monitor for 24hr
|
| Comparator Agent |
Ropivacaine with Dexmedetomidine and Ropivacaine with Nalbuphine |
Drug Ropivacaine 0.5% + Dexmedetomidine 1 mcg per kg
Route Ultrasound guided ESP block at level of T3.
Total Volume 35 ml
Drug Ropivacaine 0.5 percentage + Nalbuphine 10 mg per kg.
Route Ultrasound guided ESP block at level of T3.
Total Volume 35 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients under ASA Physical Status I and II undergoing breast augmentation surgery Plastic Surgery.
Gender Transgender patients.
Patients with BMI between 20 to 30 kg per m². |
|
| ExclusionCriteria |
| Details |
Severe spinal deformity.
Known allergy to local anaesthetics.
Systemic illnesses such as uncontrolled hypertension, diabetes, seizure disorder, cardiopulmonary disease.
Bleeding disorders, block site infection, hepatic or renal dysfunction.
BMI more than 30 kg per m².
Patients on anticoagulants/blood thinners.
History of head injury.
Psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in minutes or hours within 24 hours post surgery. |
Duration of postoperative analgesia measured as the time interval between administration of ESP block and first rescue analgesic requirement, recorded in baseline , 12th hr and 24th hr post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 4 |
|
Date of First Enrollment (India)
|
17/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/10/2024 |
| 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
|
This prospective, randomized, double blind study was conducted to compare the postoperative analgesic efficacy of two drug combinations in ultrasound guided erector spinae plane ESP block for patients undergoing breast augmentation surgery. One group received 0.5 Percentage ropivacaine with dexmedetomidine, while the other received 0.5 Percentage ropivacaine with nalbuphine.
The study assessed parameters such as Duration and quality of postoperative analgesia Total rescue analgesic requirement Hemodynamic stability and side effects
The results indicated which adjuvant dexmedetomidine or nalbuphine when combined with ropivacaine, provided superior and longer-lasting pain relief with minimal adverse effects. |