| CTRI Number |
CTRI/2024/07/070960 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Subcutaneous infiltration of local anesthetic for postoperative pain following breast surgery |
|
Scientific Title of Study
|
Portal blocks for postoperative pain relief in patients undergoing breast surgery-A Case Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NamrathaM |
| Designation |
PG student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology,JNMC,Nehru Nagar,Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8971747075 |
| Fax |
|
| Email |
dr.namratha336@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NamrathaM |
| Designation |
PG student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology,JNMC,Nehru Nagar,Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8971747075 |
| Fax |
|
| Email |
dr.namratha336@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Kerur |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology,JNMC,Nehru Nagar,Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8310127767 |
| Fax |
|
| Email |
ravikerur@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Jawaharlal Nehru Medical College,Nehru Nagar,Belagavi,Karnataka-590010 |
|
|
Primary Sponsor
|
| Name |
Namratha.M |
| Address |
Jawaharlal Nehru Medical College,Belagavi-10 |
| 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 |
| DrNamrathaM |
KLEs Dr.Prabhakar Kore Hospital and Medical Research Center |
Department of Anesthesia,
Jawaharlal Nehru Medical College ,Nehru Nagar.Belagavi,Karnataka-590010
Belgaum
KARNATAKA |
8971747075
dr.namratha336@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Instituitional Ethics Committee |
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 |
| Comparator Agent |
PORTAL BLOCKS FOR POSTOPERATIVE PAIN RELIEF IN PATIENTS UNDERGOING BREAST SURGERY |
Injection Paracetamol 1g I.V infusion every 8th hourly and Injection Tramadol 50mg I.V 12th hourly |
| Intervention |
PORTAL BLOCKS FOR POSTOPERATIVE PAIN RELIEF IN PATIENTS UNDERGOING BREAST SURGERY |
Subcutaneous injection of mixture of 8ml Injection 0.125% Bupivacaine + 1ml Triamcinolone 40mg + 1ml Injection Clonidine 30mcg. 3ml of this mixture is administered in mid-sternal area at the level 4th rib and 3ml in the mid- axillary line of the operated side at the level of 7th rib once the NRS Score is more than or equal to 7 |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1)ASA Grade 1,2
2)Age between 30-70 years
3)Female patients undergoing breast surgery |
|
| ExclusionCriteria |
| Details |
1)Patient Refusal
2) ASA III and above
3) Patient with Coagulation disorders or on anticoagulant and antiplatelet drugs
4) Infection at the site of injection
5) Known allergy to the any of study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of portal blocks for post-operative pain management in woman undergoing Breast surgery |
20minutes after block, followed by every 2 hourly upto 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate patient satisfaction & effects on hemodynamic parameters |
starting from 20 minutes after the block, followed by every 2 hours for 48hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="5"
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
|
After obtaining institutional ethical committee clearance, this case
control study is carried out in 60 female patients (American Society of
Anesthesiology [ASA] physical status 1,2) undergoing breast surgery during the
period of January 2024 to June 2024.
Patients are allocated into two groups as Group A and Group P using
computer generated software.
a) Group P-Subcutaneous
infiltration of mixture of 8ml Injection 0.25% Bupivacaine + 1ml Triamcinolone
40mg + 1ml Injection Clonidine 30mcg. 3ml of this mixture is administered in
mid-sternal area at the level 4th rib and 3ml in the mid- axillary
line of the operated side at the level of 7th rib once the NRS Score is more
than or equal to 7.
b)
Group A-Paracetamol 1g I.V infusion
every 8th hourly and Injection Tramadol 50mg 12th hourly An
independent observer collects the data. NRS score will be documented postoperatively
every hourly for first six hours then every 4th hourly till 48 hrs. All patients will be monitored for pain using
NRS score and hemodynamics with pulse rate and blood pressure.
If
NRS Score >= 7 despite portal block, rescue analgesia is provided with
Injection Paracetamol 1g I.V Infusion and Injection Tramadol 50mg I.V
|