| CTRI Number |
CTRI/2024/05/067275 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| 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
|
Comparing the effect of ultrasound-guided pectoral nerve block versus thoracic epidural block using ropivacaine for postoperative pain relief after modified radical mastectomy: A randomized controlled trial |
|
Scientific Title of Study
|
COMPARING THE EFFICACY OF ULTRASOUND-GUIDED PECTORAL NERVE BLOCK VERSUS THORACIC EPIDURAL BLOCK USING ROPIVACAINE FOR POSTOPERATIVE ANALGESIA AFTER MODIFIED RADICAL MASTECTOMY A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Vignesh |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
09786250754 |
| Fax |
|
| Email |
gvignesh791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789892444 |
| Fax |
|
| Email |
rajeshanaes15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Vignesh |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
09786250754 |
| Fax |
|
| Email |
gvignesh791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308 |
|
|
Primary Sponsor
|
| Name |
Dr G Vignesh |
| Address |
Post Graduate,
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308. |
| 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 G Vignesh |
Karpaga vinayaga institute of medical sciences and research center |
Dept of anesthesia,karpaga vinayaga medical college
GST ROAD, CHINNA KOLAMBAKKAM,
PALAYANOOR (PO),
CHENGALPATTU (DT) 603 308
MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU |
09786250754
gvignesh791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(Human studies) |
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 |
| Intervention |
Ropivacaine 0.2% for ultrasound guided pectoral nerve block
Pectoral(PecS I )block-15ml
Pectoral(PecS II)block-10ml |
Ropivacaine 0.2% for ultrasound guided pectoral nerve block
Pectoral(PecS I )block-15ml
Pectoral(PecS II)block-10ml
To Compare the better efficacy of ultrasound-guided pectoral nerve block versus thoracic epidural block using ropivacaine 0.2% for postoperative analgesia after modified radical mastectomy
Pain intensity assessment by VAS Scale @ 30mins,4hrs,8hrs,12hrs,20hrs,
24hrs |
| Comparator Agent |
Ropivacaine 0.2% single shot for thoracic epidural block between T4 & T5 Vertebrae |
Ropivacaine 0.2% single shot for thoracic epidural block between T4 & T5 Vertebrae
To Compare the better efficacy of ultrasound-guided pectoral nerve block versus thoracic epidural block using ropivacaine 0.2% for postoperative analgesia after modified radical mastectomy Pain intensity assessment by VAS Scale @ 30mins,4hrs,8hrs,12hrs,20hrs, 24hrs
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA classification I & II
Age of above 18 to 60 yrs
Posted for Modified radical mastectomy
|
|
| ExclusionCriteria |
| Details |
Patient not willing to participate
History of Spine pathology or spine surgeries
Patient with infection at the block site
Coagulopathy
Morbid obesity
Allergy to LA agent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the efficacy of post operative analgesia of ropivacaine in two groups.
|
To Compare the efficacy of post operative analgesia of ropivacaine in two groups at 30mins,4hrs,8hrs,12hrs,20hrs,
24hrs and their analgesic duration
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of rescue analgesia |
4hrs,8hrs,12hrs,20hrs,
24hrs |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
23/05/2024 |
| 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="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
|
To compare the better analgesic efficacy of two groups i.e., ropivacaine (0.2%) for post operative pain relief in patient undergoing modified radical mastectomy (Ultrasound guided pectoral nerve block vs thoracic epidural block)
In this study, two groups
T group(thoracic epidural block) patient were received a single shot of 15ml of 0.2% ropivacaine between t4 and t5 vertebrae.
PECS(p group)The pectoral nerve (PecS II) block, which was first described by Blanco et al.,is a relatively new, less-invasive technique of postoperative analgesia and is devoid of major side effects. The Pecs II block is an interfascial plane block, where Ropivacaine 0.2%-10ml is deposited into the plane between the pectoralis major muscle (PMm) and the pectoralis minor muscle (Pmm) (PecS I block) and Ropivacaine 0.2%-15ml is injected between Pmm and the serratus anterior muscle at the third rib (Pecs II block). This novel technique also blocks long thoracic and thoracodorsal nerves, lateral and medial pectoral nerves along with lateral branches of intercostal nerves, exiting at the level of mid-axillary line to innervate the breast and the skin innervate from T2 to T6, thus providing good analgesia for mastectomy and axillary clearance.
Assessment of post operative pain in both groups will be done using VAS (Visual Analogue Scale) score 1-10 at 30min, 4hrs, 8hrs,12 hrs,20 hrs and 24hrs after surgery and the data will be recorded in both groups.
If a VAS score of 4 is reported rescue analgesia will be given at that time using Inj.Tramadol 50mg iv and the frequency of the rescue analgesics will also be noted for both the groups. Side effects of ropivacaine-nausea and vomiting. |