| CTRI Number |
CTRI/2024/07/069749 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided Pectoral Nerve Block versus Thoracic epidural for postoperative analgesia in patients posted for modified radical mastectomy |
|
Scientific Title of Study
|
Randomised comparative study of efficacy of ultrasound guided pectoral nerve block versus thoracic epidural for postoperative analgesia after modified radical mastectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thota Geetha Sravanthi |
| Designation |
Jr.Resident |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Rangaraya Medical College,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
8885128558 |
| Fax |
|
| Email |
geetha0132@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Athaluri Vishnu Vardhan |
| Designation |
Professor and Head of Department |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Rangaraya Medical College,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9849577999 |
| Fax |
|
| Email |
athalurivishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athaluri Vishnu Vardhan |
| Designation |
Professor and Head of Department |
| Affiliation |
Rangaraya Medical College, Kakinada |
| Address |
Department of Anaesthesiology,
Government General Hospital,
Rangaraya Medical College,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9849577999 |
| Fax |
|
| Email |
athalurivishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Rangaraya Medical College,
Kakinada, East Godavari - 533001 |
|
|
Primary Sponsor
|
| Name |
Thota Geetha Sravanthi |
| Address |
Department of anaesthesiology,
Rangaraya medical College, Kakinada, East Godavari, Andhra Pradesh 533001 |
| 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 Thota Geetha Sravanthi |
Government General Hospital, Kakinada |
Surgery Operation Theatre Complex, Theatre No.2, department of Anaesthesiology, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH |
8885128558
geetha0132@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rangaraya Medical College Institutional Ethics Committee Cell |
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 |
Pectoral Nerve Block |
Ultrasound guided Pectoral Nerve Block with 18ml 0.25% Bupivacaine + 0.2ml Dexmedetomidine unilaterally within 5mins before surgical incision |
| Intervention |
Thoracic Epidural |
Thoracic Epidural preoperatively with 18ml 0.25% Bupivacaine + 0.2ml Dexmedetomidine within 5mins before surgical incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age group 18-70 years with American Society of
Anaesthesiologists (ASA) I-III.
2. Patients with unilateral modified radical mastectomy or breast
conservation surgery. |
|
| ExclusionCriteria |
| Details |
1.Patient not giving consent.
2.Coagulation disorders or those on anticoagulants.
3.Thrombocytopenia (platelet count less than 1 lakh).
4.Prior mastectomy surgery.
5.With infection at the planned injection site.
6.Obese patients with BMI more than 35kg/m2.
7.Allergy to anaesthetic drugs.
8.Previous failed blocks.
9.Anamolies of vertebral column. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Score |
0mins
1hr
2hrs
4hrs
6hrs
12hrs
16hrs
20hrs
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rescue Analgesia |
0mins
1hr
2hrs
4hrs
6hrs
12hrs
16hrs
20hrs
24hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/08/2024 |
| 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="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
|
Postoperative analgesia is essential for patients undergoing Modified Radical Mastectomy. It helps in faster recovery and increases patient satisfaction scores.
My trial aims to compare the efficacy and safety of an Ultrasound guided Pectoral nerve block versus Thoracic Epidural for postoperative analgesia after modified radical mastectomy. |