| CTRI Number |
CTRI/2018/04/013013 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
this is a study to determine the effectiveness of serratus anterior plane block in flap surgeries of trunk |
|
Scientific Title of Study
|
To study the efficacy of serratus anterior plane block in patients undergoing trunk based flap surgeries - Pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaddi Gowtham |
| Designation |
junior resident |
| Affiliation |
AIIMS |
| Address |
AB8, 8th floor, Department of Anesthesiology, Critical care, Pain Medicine, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9958474108 |
| Fax |
|
| Email |
gowthamvaddi003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhavi Sawhney |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
3rd floor, JPNATC, Department of Anesthesiology, Critical care, Pain Medicine, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9818357051 |
| Fax |
|
| Email |
drchhavisawhney@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaddi Gowtham |
| Designation |
junior resident |
| Affiliation |
AIIMS |
| Address |
AB8, 8th floor, Department of Anesthesiology, Critical care, Pain Medicine, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9958474108 |
| Fax |
|
| Email |
gowthamvaddi003@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| VADDI GOWTHAM |
All India Institute of Medical Sciences |
Department of Anesthesiology, Critial care and Pain Medicine, AB8, 8th floor, AIIMS
New Delhi
DELHI |
9958474108
gowthamvaddi003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients Undergoing Trunk Based Flap Surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
local infiltration |
0.25% of 20 ml ropivacaine injected as local infilreation |
| Intervention |
serratus anterior plane block |
0.25% of 20 ml ropivacaine injected in between serratus anterior plane and 4th rib under ultra sound guidance and total duration of block is 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Undergoing Trunk Based Flap Surgeries |
|
| ExclusionCriteria |
| Details |
1. Patients refusal
2. Patients with Coagulopathy (INR>1.5, Platelet count <50,000/cu mm)
3. Patients with infection at the local site
4. Patients with allergy to the local anesthetic drug
5. Patients undergoing infraumbilical trunk based flaps |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Morphine consuption in both groups |
24 hrs period after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total intraoperative Fentanyl requirement
2. Time to first activation of PCA
3. VAS - Immediate postoperative period, 2 hrs, 4 hrs, 6 hrs, 12 hrs, 24 hrs
4. The complications of Serratus anterior plane block |
Intraoperative period and 24 hrs period after the surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized control trial for comparision of efficacy serratus anterior plane block in patients undergoing trunk based flap sugeries with local infiltration, which will be conducted in All India Institute of Medical Sciences. The primary outcome of this study is to know assess the postoperative morphine consuption over 24 hrs in patients after receiving serratus anterior plane block for trunk based flap surgery. The seconday outcome is to study the complications and adverse effects associated with serratus anterior plane block |