| CTRI Number |
CTRI/2024/10/074993 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of ultrasound guided pectoral nerve block verus paravertebral block for post operative pain relief in carcinoma breast surgeries. |
|
Scientific Title of Study
|
Comparative study of ultrasound guided pectoral nerve block verus paravertebral block for post operative analgesia in carcinoma 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 |
Subash TS |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions medical college and hospital |
| Address |
OT complex
first floor,
department of anaesthesiology
Vinayaka Missions medical college and hospital
Kottuchery
Karaikal
Karaikal PONDICHERRY 609609 India |
| Phone |
7010567129 |
| Fax |
|
| Email |
subashkumarr66@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Cheran K |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions medical college and hospital |
| Address |
OT complex
first floor,
department of anaesthesiology
Vinayaka Missions medical college and hospital
Kottuchery
Karaikal
Karaikal PONDICHERRY 609609 India |
| Phone |
9443144652 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Subash TS |
| Designation |
Post-Graduate |
| Affiliation |
Vinayaka Missions medical college and hospital |
| Address |
OT complex
first floor,
department of anaesthesiology
Vinayaka Missions medical college and hospital
Kottuchery
Karaikal
Karaikal PONDICHERRY 609609 India |
| Phone |
7010567129 |
| Fax |
|
| Email |
subashkumarr66@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT complex
first floor,
department of anaesthesiology
Vinayaka Missions medical college and hospital
Kottuchery
Karaikal
Pondicherry
India
Pincode 609609 |
|
|
Primary Sponsor
|
| Name |
Subash TS |
| Address |
OT complex
first floor,
department of anaesthesiology
Vinayaka Missions medical college and hospital
Kottuchery
Karaikal
Pondicherry
India
Pincode 609609 |
| 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 |
| Dr Subash TS |
Vinayaka Missions medical college and hospital |
OT complex
first floor,
department of anaesthesiology Karaikal PONDICHERRY |
7200701094
subashkumarr66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinyaka missions medical college and hospital |
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 |
NIL |
NIL |
| Intervention |
Paravertebral block |
Under USG guidance,Paravertebral block given once using 20ml of 0.25Percentage Bupivacaine local anaesthetic before induction of anaesthesia |
| Intervention |
Pectoral Nerve block |
Under USG guidance,Pectoral nerve block given once using 20ml of 0.25Percentage Bupivacaine local anaesthetic before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing carcinoma breast surgery |
|
| ExclusionCriteria |
| Details |
Pregnant female and lactating mother,
patients Allergic to local anaesthesia,
patients with Coagulopathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of blockade and recovery in the postoperative period between pectoral nerve block and paravertebral block in patient undergoing carcinoma breast surgeries. |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time taken for rescue analgesia dose requirements,
To monitor Haemodynamic parameter in post operative period |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
20/10/2024 |
| 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
|
General anesthesia (GA) is by far the most common utility used for breast surgeries. Different regional techniques have been tried during breast surgery, including thoracic epidural, thoracic paravertebral block, thoracic spinal block and Pecs block.
This study compares postoperative analgesia between ultrasound-guided pectoral nerve block and paravertebral block in carcinoma breast surgeries performed under general anesthesia (GA). Here’s a breakdown:
1. Ethical Approval: The study begins with obtaining approval from an ethical committee, ensuring that the research meets ethical standards.
2. Informed Consent: Informed written consent is obtained from each patient, ensuring they understand the study’s purpose, procedures, and risks.
3. Inclusion and Exclusion Criteria: Criteria are established to select eligible patients for the study, ensuring they meet specific characteristics while excluding those with factors that could confound the results.
4. Patient Selection: Patients with an indication for breast surgery are selected for inclusion in the study.
5. Randomization: Patients undergoing breast surgery under general anesthesia are randomly assigned to one of two groups: Group A receives a pectoral nerve block, while Group B receives a paravertebral block.
6. Postoperative Assessment: Following surgery, both sensory and motor assessments are conducted at regular intervals (every 30 minutes) until the complete regression of the block is observed. This allows for monitoring the duration and effectiveness of each nerve block technique.
7. Pain Assessment: Postoperative pain is assessed using the Visual Analog Scale (VAS), a commonly used tool for subjective pain evaluation.
8. Objective: The primary objective of the study is to compare the efficacy of ultrasound-guided pectoral nerve block versus paravertebral block in providing postoperative analgesia for carcinoma breast surgeries performed under general anesthesia.
|