| CTRI Number |
CTRI/2025/04/084574 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| 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
|
To compare of ultrasound guided erector spinae block versus paravertebral block for post operative pain management in breast surgeries |
|
Scientific Title of Study
|
Comparison of ultrasound guided erector spinae block versus paravertebral block for post operative analgesia in breast surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADevaraajulu |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateswara medical college hospital and research centre |
| Address |
Department of Anaesthesiology and critical care. Sri Venkateswara medical college hospital and research centre.No 13-A, Pondy Villupuram main road, Ariyur
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8610144450 |
| Fax |
|
| Email |
devaraajulunaidu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RKrishnaprabu |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateswara medical college hospital and research centre |
| Address |
Department of Anaesthesiology and critical care. Sri Venkateswara medical college hospital and research centre.No 13-A, Pondy Villupuram main road, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RKrishnaprabu |
| Designation |
Professor and HOD |
| Affiliation |
Sri Venkateswara medical college hospital and research centre |
| Address |
Department of Anaesthesiology and critical care. Sri Venkateswara medical college hospital and research centre.No 13-A, Pondy Villupuram main road, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara medical college hospital and research centre, No 13-A,Pondy-Villupuram main road,Ariyur,Puducherry,India,605102 |
|
|
Primary Sponsor
|
| Name |
Dr A.Devraajulu |
| Address |
Sri Venkateswara medical college hospital and research centre, No 13-A,Pondy-Villupuram main road,Ariyur,Puducherry,India,605102 |
| Type of Sponsor |
Other [Self( principal investigator)] |
|
|
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 |
| DrDevaraajulu |
Sri Venkateswara medical college hospital and research centre |
No 13 A Department of Anaesthesiology, OT complex, Sri Venkateswara medical college hospital and research centre, Pondicherry
Pondicherry
PONDICHERRY |
8122309193
devaraajulunaidu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae block (Group E) |
Group E : 0.25% levobupivacaine 30ml |
| Comparator Agent |
Paravertebral block (Group P) |
O.25% levobupivacaine 30ml |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class 1 or 2
BMI 18 to 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Know Hypersensitivity to LA
Chronic systemic illness
Bleeding diathesis
Infection at local site
Pregnancy
Patient with spinal deformities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to first rescue analgesia in both study groups. |
30mins,60mins,120mins4hrs,8hrs,12hrs,24hrs,48hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the total tramadol consumption for 1st 24hrs.
VAS score at 1hr,4hrs,12hrs,24hrs.
Complications following erector spinae block and paravertebral block |
30mins,60mins,120mins,4hrs,8hrs,12hrs,24hrs,48hrs. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
24/04/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [devaraajulunaidu@gmail.com].
- For how long will this data be available start date provided 07-02-2024 and end date provided 23-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The comparison of ultrasound-guided erector spinae block (ESB) versus paravertebral block (PVB) in breast surgeries, particularly when using levobupivacaine as an analgesic. Erector Spinae Block (ESB): Involves injecting anesthetic in the fascial plane deep to the erector spinae muscle, targeting the dorsal rami of the spinal nerves. It provides analgesia by spreading along the paravertebral space and affecting multiple dermatomes. -Paravertebral Block (PVB): Involves injecting anesthetic into the paravertebral space, directly affecting the spinal nerves. This can provide more targeted analgesia for specific dermatomes.
Both blocks are effective for postoperative pain relief in breast surgeries. Some studies suggest that PVB may provide better analgesia due to its direct targeting of the intercostal nerves.
Technical Considerations - Ultrasound Guidance: Both techniques benefit from ultrasound guidance, improving accuracy and reducing complication rates. ESB is often easier to perform and visualize compared to PVB.
-In breast surgeries using levobupivacaine, both the erector spinae block and paravertebral block provide effective analgesia. The choice between them may depend on the specific surgical procedure, the expertise of the clinician, and patient factors. Further research comparing these techniques directly in large-scale studies would help clarify their relative benefits and optimal usage.
Levobupivacaine is less cardio toxic compared to other analgesia |