| CTRI Number |
CTRI/2019/01/017194 [Registered on: 22/01/2019] Trial Registered Prospectively |
| Last Modified On: |
14/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Serratus anterior plane block for pain relief in breast surgeries |
|
Scientific Title of Study
|
Evaluation of effectiveness of ultrasound guided Serratus Anterior Plane block for postoperative analgesia in modified radical mastectomy surgeries- A prospective, randomized, control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saravanan |
| Designation |
Associate Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Room no.201, SRM medical college hospital and research centre,
SRMIST
Potheri
Kancheepuram
TAMIL NADU
saravanan
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saravanan |
| Designation |
Associate Professor |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Room no.201, SRM medical college hospital and research centre,
SRMIST
Potheri
Kancheepuram
TAMIL NADU
saravanan
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KYogalakshmi |
| Designation |
Postgraduate student |
| Affiliation |
SRM medical college hospital and research centre |
| Address |
Room no.209, SRM medical college hospital and research centre,
SRMIST
Potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
yogalakshmikani@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research centre,
SRM IST, SRM Nagar, Potheri,
kattankulathur, Kancheepuram District-603203 |
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital and research centre |
| Address |
SRMIST, Potheri |
| 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 |
| saravanan |
SRM medical college hospital |
Room no.201, SRM medical college hospital, SRMIST, Potheri.
Kancheepuram
TAMIL NADU |
9884001153
drcrsaravanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
general anaesthesia |
patients with MRM surgeries under GA are observed for postoperative pain and analgesic consumption. |
| Intervention |
serratus anterior plane block |
ultrasound guided serratus anterior plane block for postoperative analgesia in modified radical mastectomy surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1&2 patients posted for MRM surgeries
60-100kg
age 18-60 years |
|
| ExclusionCriteria |
| Details |
ASA 3 and above
Patients not willing for the study
Allergy to local anaesthetics
Coagulation abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of postoperative analgesia |
from the administration of block to onset of pain requiring analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| analgesic consumption in the postoperative period |
from the surgery end to 24hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
28/01/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
44 ASA 1&2 patients posted for modified radical mastectomy surgeries are randomly divided into two groups - group A patients receive ultrasound guided Serratus Anterior Plane block under General anaesthesia with 20 ml of 0.25%ropivacaine with 8mg Dexamethasone and group B patients receive general anaesthesia without any block. Postoperatively all patients will be administered PCA morphine pump with basal infusion rate of 0.1mg/hr and bolus of 1mg with lockout interval of 10min. The time to request for first dose of analgesia and the total morphine consumed in 24hours are noted and compared. The side effects, if any are also observed. The hypothesis of the study is by performing Serratus Anterior Plane block, the duration of postoperative analgesia is prolonged and morphine consumption in the postoperative period is decreased. |