| CTRI Number |
CTRI/2020/02/023624 [Registered on: 27/02/2020] Trial Registered Prospectively |
| Last Modified On: |
26/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
A study to compare the efficacy of local Anaesthetic (Ropivacaine) alone and in combination with opiod or ketamine as adjuvent in periphral nerve block for Pain Relief following Breast surgery
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Scientific Title of Study
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A study to compare the efficacy of ropivacaine alone and in combination with fentanyl or ketamine in modified pectoral block (PEC II) for analgesia following modified radical mastectomy (MRM)
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| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Kiran |
| Designation |
Senior Professor |
| Affiliation |
Department of Anaesthesia and Critical Care Pt B.D.Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical care Pt B.D.Sharma PGIMS,
Rohtak
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
DrShashi64@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Davender Chahal |
| Designation |
PG student |
| Affiliation |
Department of Anaesthesia and Critical Care Pt B.D.Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical care Pt B.D.Sharma PGIMS,
Rohtak
HARYANA
124001
India |
| Phone |
9728069762 |
| Fax |
|
| Email |
jgdchahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Davender Chahal |
| Designation |
PG student |
| Affiliation |
Department of Anaesthesia and Critical Care Pt B.D.Sharma PGIMS |
| Address |
Department of Anaesthesiology and Critical care Pt B.D.Sharma PGIMS,
Rohtak
HARYANA
124001
India |
| Phone |
9728069762 |
| Fax |
|
| Email |
jgdchahal@gmail.com |
|
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Source of Monetary or Material Support
|
| Institutional,Pt B.D.Sharma PGIMS
Rohtak
(Haryana)
124001 |
|
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Primary Sponsor
|
| Name |
Department of Anaesthesia and Critical Care |
| Address |
Pt B.D.Sharma PGIMS
Rohtak
(Haryana)
124001 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Davender chahal |
Pt B.D.Sharma PGIMS |
Department of Anaesthesia and Critical Care Pt B.D.Sharma PGIMS
Rohtak
HARYANA |
9728069762
jgdchahal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified pectoral blockPEC II is given for analgesia in Modified Radical Mastectomy with Ropivacaine alone |
Requirement of rescue analgesic in modified pectoral block PEC II for analgesia in Modified Radical Mastectomy postoperatively |
| Comparator Agent |
Modified pectoral blockPEC II is given for analgesia in Modified Radical Mastectomy with Ropivacaine plus Fentanyl |
Requirement of rescue analgesic in modified pectoral blockPEC II for analgesia in Modified Radical Mastectomy postoperatively |
| Comparator Agent |
Modified pectoral blockPEC II is given for analgesia in Modified Radical Mastectomy with Ropivacaine plus Ketamine |
Requirement of rescue analgesic in modified pectoral blockPEC II for analgesia in Modified Radical Mastectomy postoperatively |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All women aged between 20-60 years, belonging to American Society of Anesthesiologists (ASA) physical status I-III undergoing modified radical mastectomy (MRM) under general anaesthesia will be included in this study. |
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| ExclusionCriteria |
| Details |
Patients having contraindication to regional block, history of local anaesthetic allergy, psychiatric disorders, chronic opioid use, chachexic women and refusal to participate in the study will not been included. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
1. Intraoperative haemodynamic monitoring
2. Postoperative haemodynamic monitoring
3. Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously)
4. Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously)
5. Diclofenac sodium & Tramadol consumption in surgical ward
6. VAS Score
7. Nausea score
8. Sedation score
9. Side effects observed a)Hypotension b)Bradycardia c) any other
10. Antiemetics required
|
1. Intraoperative haemodynamic monitoring
2. Postoperative haemodynamic monitoring
3. Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously)
4. Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously)
5. Diclofenac sodium & Tramadol consumption in surgical ward
6. VAS Score
7. Nausea score
8. Sedation score
9. Side effects observed a)Hypotension b)Bradycardia c) any other
10. Antiemetics required
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative haemodynamic monitoring
2. Postoperative haemodynamic monitoring
3. Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously)
4. Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously)
5. Diclofenac sodium & Tramadol consumption in surgical ward
6. VAS Score
7. Nausea score
8. Sedation score
9. Side effects observed a)Hypotension b)Bradycardia c) any other
10. Antiemetics required
|
The following outcome messures will be assesed in all the three groups 1.Ropivacaine alone 2.Ropivacaine plus Fentanyl 3.Ropivacaine plus Ketamine after giving modified pectoral blockPEC II for analgesia in Modified Radical Mastectomy intra operatively and post operatively for 24 hrs. |
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Target Sample Size
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Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
28/02/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
The aim and objective of the thesis is to evaluate Whether ropivacaine alone or in combination with fentanyl or ketamine will be effective analgesics for modified pectoral block in patients following modified radical mastectomy Adult patients aged between 18-60 years of Female sex belonging to American Society of Anesthesiologists (ASA) physical status I-III undergoing breast surgery under general anaesthesia will be included in this study and we will asses Intraoperative haemodynamic monitorin,Postoperative haemodynamic monitoring,Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously),Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously),Diclofenac sodium & Tramadol consumption in surgical ward,VAS Score,Nausea score,Sedation score,Side effects observed a)Hypotension b)Bradycardia c) any other and Antiemetics required.Data will be copiled and appropriate stastical test will be done to analyse the result |