| CTRI Number |
CTRI/2018/03/012876 [Registered on: 27/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Various Drugs To Improve Pain Relief After Breast Cancer Surgery |
|
Scientific Title of Study
|
A study to compare postoperative analgesia in patients undergoing modified radical mastectomy under epidural ropivacaine alone or using butorphanol versus fentanyl as adjuvant to ropivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor And Head Department Of Anesthesia |
| Affiliation |
Sri Guru Ram das institute of Medical Sciences And Research |
| Address |
Department Of Anaesthesiology And Critical Care Sgrdimsar Vallah Amritsar
Sri Guru Ramdas Institute Of Medical Sciences And Research Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiteshwar Walia |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department Of Anaesthesiology And Critical Care
Amritsar
PUNJAB
143501
India |
| Phone |
9878339933 |
| Fax |
|
| Email |
chiteshwarwalia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishpuneet singh |
| Designation |
PG Resident |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department Of Anaesthesiology And Critical Care
Amritsar
PUNJAB
143501
India |
| Phone |
9855433668 |
| Fax |
|
| Email |
ishpuneetsingh701@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram das Institute of Medical Sciences And Research |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department Of Anaesthesia |
| Type of Sponsor |
Private medical college |
|
|
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 Ruchi Gupta |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
Department Of Anaesthesiology And Critical Care
Amritsar
PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE SGRDIMSAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
breast cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DRUGS- Ropivacaine, ropivacaine with butorphanol 1mg, ropivacaine with fentanyl 100 mcg |
To compare the
pain relief and complications after epidural administration of ropivacaine or
ropivacaine–butorphenol or ropivacaine-fentanyl or complications arising due
to the procedure itself, in patients undergoing Modified Radical
Mastectomy(MRM). The study will be conducted on 90 females undergoing
Modified Radical Mastectomy will be divided into 3 groups with 30 patients
each. Group A will be given ropivacaine 0.25% 6ml with 2 ml of normal saline
through epidural route; Group B will receive 6ml of 0.25% ropivacaine with
butorphanol 1ml (1mg/ml) and 1 ml normal saline through epidural
route.;Group C will receive 6ml of 0.25% ropivacaine with 2 ml fentanyl (100
micrograms) through epidural route. The post operative analgesia will be
given as epidural top ups in the form of ropivacaine(0.125% 6ml) |
| Intervention |
epidural injection of ropivacaine alone versus butorphanol or fentanyl as adjuvant to ropivacaine |
To compare postoperative pain relief using epidural ropivacaine,
ropivacaine-butorphanol, ropivacaine–fentanyl in patients undergoing
Modified Radical Mastectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 & 2 |
|
| ExclusionCriteria |
| Details |
1. Patients having bleeding diathesis
2. Patients on any anticoagulant therapy
3. Patients with known hypersensitivity to local anaesthetics or study
drugs.
4. Patients having history of drug abuse
5. Patients who are mentally retarded
6. Patient suffering from uncontrolled asthma, cardiac, respiratory, renal,
thyroid, hepatic and CNS disorders.
7. Patients with local sepsis or spinal deformity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration Of Postoperative Analgesia |
Duration Of Analgesia From Drug Administration To VAS Equals To Or More Than 4 in Postoperative Period In First 24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative Haemodyanamic Stability
2.Total Dose Of Postoperative Analgesic Requirement |
1. Intraoperative Haemodyanamical Stability Upto End of Surgery
2. In First 24 Hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
Modification(s)
|
31/01/2017 |
| 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="1"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
The aim of this study is to compare the pain relief and complications after epidural administration of ropivacaine or ropivacaine–butorphenol or ropivacaine-fentanyl or complications arising due to the procedure itself, in patients undergoing Modified Radical Mastectomy(MRM). The study will be conducted on 90 females undergoing Modified Radical Mastectomy will be divided into 3 groups with 30 patients each. Group A will be given ropivacaine 0.25% 6ml with 2 ml of normal saline through epidural route; Group B will receive 6ml of 0.25% ropivacaine with butorphanol 1ml (1mg/ml) and 1 ml normal saline through epidural route.; Group C will receive 6ml of 0.25% ropivacaine with 2 ml fentanyl (100 micrograms) through epidural route. The postoperative analgesia will be given as epidural top-ups in the form of ropivacaine(0.125% 6ml) and the data from the above study will be systematically collected, compiled and statistically analyzed to draw relevant conclusions. |