| CTRI Number |
CTRI/2020/02/023655 [Registered on: 28/02/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of ropivacaine versus dexmedetomidine or ketamine in modified PECS II block in patients undergoing breast surgery: A Randomized trial |
|
Scientific Title of Study
|
Efficacy of dexmedetomidine and ketamine as an adjuvant with ropivacaine in PECS II block among the patients undergoing modified radical mastectomy/ breast conservation surgery: A Randomized double blind controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharani Lenin |
| Designation |
Post Graduate |
| Affiliation |
All India Institute of medical sciences patna |
| Address |
Department of Anaesthesiology
All india institute of medical sciences,Patna
Patna
BIHAR
801505
India |
| Phone |
9677235808 |
| Fax |
|
| Email |
dharanidr29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
Associate professor |
| Affiliation |
All India Institute of medical sciences patna |
| Address |
Department of Anaesthesiology
All india institute of medical sciences,Patna
Department of Anaesthesiology
AIIMS , Patna
Patna
BIHAR
801505
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drraj76pmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
Associate professor |
| Affiliation |
All India Institute of medical sciences patna |
| Address |
Department of Anaesthesiology
All india institute of medical sciences,Patna
Department of Anaesthesiology
All india institute of medical sciences,Patna
Patna
BIHAR
801505
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drraj76pmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences patna |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences patna |
| Address |
All india institute of medical sciences patna |
| 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 |
| Dr Rajnish Kumar |
All india institute of medical sciences |
Department of anaesthesiology operation theatre room no 9 & 20
Patna
BIHAR |
7783865337
drraj76pmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCE PATNA |
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 |
comparing 0.2% ropivacaine alone with dexmeditomidine 1 mcg/kg body weight or ketamine 1 mg/kg body weight in PECS 2 BLOCK in patient undergoing breast surgeries |
total 30 ml volume of drug will be used
10ml between interfascial plane of pectoralis major and minor,20ml between interfascial plane of pectoralis minor and serratus anterior
frequency preoperatively after induction block will be carried out patient will be followed up for 48 hours route of administration is on interfascial plane between the muscles |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1) Female population aged between 18-65 years
2) ASA I & II
3) Patients undergoing breast surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with underlying severe cardio-pulmonary compromise
Morbid obesity BMI more than or equal to 35
Chest wall infiltration
Presence of malignant breast mass in the field of block performance
Pregnancy,lactation, dementia.
Allergy to Local Anesthetic or adjuvants,
Patients already on prescribed oral opioid analgesics or psychotropic
agents
Post radiation status of breast or axilla |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total duration of post-operative analgesia and requirement of first rescue
analgesia by the patient using an adjuvant (dexmedetomidine or ketamine) with ropivacaine in PEC II block undergoing breast surgeries |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the total amount of intra operative and post-operative opioid consumption
To assess the nnumerical rating scale in 1,2,4,6,1,18,24,48 hours post operatively
To assess the patient satisfaction score
To measure the ramsay sedation score when patient is being shifted to PACU |
After 48 hours till discharge of the patients from hospital |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
29/02/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is one of its kind as it is the study to compare the efficacy of drugs in controlling post operative analgesia among the patient undergoing breast surgeries using PECS 2 block till date there are studies done in PECS 2 block but not with ropivacaine.since our study is mainly focused on comparing dexmeditomidine and ketamine along with ropivacaine by taking ropivacaine alone as a control group and to determine the requirement of rescue analgesia in 48 hours post operatively |