| CTRI Number |
CTRI/2019/04/018394 [Registered on: 02/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2019 |
| 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
|
Comparision of pain relief in breast cancer patients by giving full body anesthesia with nearby local injection of drugs bupivacaine along with dexmeditomidine with ultrasound in one group and full body anesthesia alone in other group of patients. |
|
Scientific Title of Study
|
Comparision of general anesthesia with ultrasound guided pecs block and serratus anterior plane block using bupivacaine and dexmeditomidine versus general anesthesia alone in modified radical mastectomy patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K SAI LAKSHMI |
| Designation |
SECONDARY DNB ANAESTHESIA PG |
| Affiliation |
SRI RAMA KRISHNA HOSPITAL |
| Address |
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9849914525 |
| Fax |
|
| Email |
sailakshminmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAMYA PARAMESWARI ARJUNAN |
| Designation |
CONSULTANT ANESTHESIOLOGIST |
| Affiliation |
SRI RAMAKRISHNA HOSPITAL |
| Address |
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044.
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9566526296 |
| Fax |
|
| Email |
arjunanramya@gmil.com |
|
Details of Contact Person
Public Query
|
| Name |
K SAI LAKSHMI |
| Designation |
SECONDARY DNB ANAESTHESIA PG |
| Affiliation |
SRI RAMAKRISHNA HOSPITAL |
| Address |
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9849914525 |
| Fax |
|
| Email |
sailakshminmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044 |
|
|
Primary Sponsor
|
| Name |
SRI RAMAKRISHNA HOSPITAL |
| Address |
SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD,NEW SIDDHAPUDUR,COIMBATORE-641044 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| K SAI LAKSHMI |
SRI RAMAKRISHNA HOSPITAL |
ANAESTHESIA DEPARTMENT,SRI RAMAKRISHNA HOSPITAL,395 SAROJINI NAIDU ROAD, NEW SIDDHAPUDUR,COIMBATORE-641044
Coimbatore
TAMIL NADU |
9849914525
sailakshminmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Randomized double blinded prospective intervensional study |
patients undergoing modified radical mastectomy are divided in to 2 groups and one group of patients are given ultrasound guided pectoralis 1 and 2 and serratus anterior plane block using 30 ml 0.25% bupivacaine along with 0.5mcg/kg body weight dexmeditomidine after induction of general anesthesia and other group of patients are not given any block and follow up both group of patients postoperatively for 24hours the first rescue analgesia was provided with inj.Tramadol 50mg intravenously every 6th hourly until VAS score less than 4 and the time is recoded. |
| Intervention |
Randomized double blinded prosprective interventional study |
patients undergoing modified radical mastectomy are divided in to 2 groups and one group of patients are given ultrasound guided pectoralis 1 and 2 and serratus anterior plane block using 30 ml 0.25% bupivacaine along with 0.5mcg/kg body weight dexmeditomidine after induction of general anesthesia and other group of patients are not given any block and follow up both group of patients postoperatively for 24hours the first rescue analgesia was provided with inj.Tramadol 50mg intravenously every 6th hourly until VAS score less than 4 and the time is recoded. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA I and II patients.
2.patients coming for elective breast surgeries.
3.patients who provide consent for the study |
|
| ExclusionCriteria |
| Details |
1.ASA III and above.
2.patient refusal.
3.patients allergic to study drug.
4.patient who are pregnant, patient on any antidepressant, antipsychotics drugs.
5.prior breast surgeries except for dianostic purpose. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the time for 1st rescue analgesia.
2.Total rescue analgesia consumed over 24 h period was recorded. |
30/3/2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of hypotension and bradycardia.
2.Incidence of PONV and pruritus |
30/3/19 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/09/2019 |
| 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="0"
Months="6"
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)?
|
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Brief Summary
|
BACKGROUND AND AIMS: Breast cancer is the most common cause in women worldwide with morethan 1 million new cases diagnosed every year. Acute post operative pain following mastectomy remains a challenge for the anaesthesiologist despite a range of treatment options available. The present study aimed to compare the post operative analgesic efficacy of PECS block and serratus anterior plane block performed under ultrasound with our standard practise of opioids and non-steroidal anti-inflammatory drugs for mastectomy. METHODS: Randomised controlled study to be conducted in our hospital after obtaining ethical clearence 60 adult female patients posted for elective unilateral modified radical mastectomy to be divided in to 2 groups as follows. Group S- general anesthesia with out block. Group BD- general anesthesia with PECI, PECII,and Serratus anterior plane block with 30ml of 0.25% Bupivacaine with 0.5mcg/kg bodyweight of Dexmeditomidine.Primary outcome to be measured as patient reported pain intensity using VAS at rest.
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