| CTRI Number |
CTRI/2019/08/020581 [Registered on: 06/08/2019] Trial Registered Prospectively |
| Last Modified On: |
23/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [pain killer] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two pain killers -Butorphanol versus Tramadol given through a cannula in the veins (medication for pain) in patients operated for breast cancer, in the immediate post surgery period. |
|
Scientific Title of Study
|
Intravenous butorphanol versus intravenous tramadol in patients operated for breast cancer- a randomized control 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 Sumitra Bakshi |
| Designation |
Professor, Departmrnt of Anaesthesia, Critical Care and Pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical care and pain,
Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Kanna |
| Designation |
Post Graduate Student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical care and pain,
Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9789980244 |
| Fax |
|
| Email |
girish.nandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish Kanna |
| Designation |
Post Graduate Student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical care and pain,
Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9789980244 |
| Fax |
|
| Email |
girish.nandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha National Fund for PG thesis,
13th floor HBNI block,
Tata Memorial Hospital,
E Borges Road,
Parel , Mumbai 12 |
|
|
Primary Sponsor
|
| Name |
Tata memorial hospital |
| Address |
Dr Ernest Borges Rd, Parel, Mumbai, Maharashtra 400012 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Kailash Sharma |
Tata Memorial Hospital |
Recovery room, Main Building,
Tata Memorial Hospital,
Dr E Borges Road
Parel
Mumbai -12
Mumbai
MAHARASHTRA |
912224177000
girish.nandan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalreviewBoard |
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: C50||Malignant neoplasm of breast, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Butorphanol |
Butorphanol, an agonist-antagonist opioid has been used in perioperative pain management. Available literature shows that butorphanol causes effective pain relief and less nausea and vomiting compared to tramadol when used epidurally. However, there is limited literature regarding the intravenous use of butorphanol and limited studies comparing these two opioids – tramadol and butorphanol. Hence we propose to compare equi-analgesic doses of intravenous butorphanol versus intravenous tramadol in patients operated for breast surgery with respect to side effects namely nausea, vomiting and sedation. |
| Comparator Agent |
Intravenous Tramadol |
Tramadol is a μ opioid receptor agonist which causes analgesia without significant respiratory depression. Hence it can be used in areas with limited monitoring. In our center, it is the mainstay opioid for post-operative patients once shifted out of recovery room. The disadvantage of tramadol is that it has high incidence of nausea and vomiting which causes patient discomfort and may cause delay in recovery and discharge. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1)Age greater than 18 years and less than 65 years.
2)ASA status I and II
3)Elective unilateral breast surgeries [simple mastectomy with axillary clearance (SMAC),Modified radical mastectomy (MRM), breast conserving therapy (BCT) and oncoplasty]
|
|
| ExclusionCriteria |
| Details |
1. Patients taking opioids on a regular basis/ opioid abuser.
2. Patients allergic to any of the following drugs- tramadol, butorphanol, paracetamol, diclofenac.
3. Patients on anti-epileptics, anti-depressants, anti-psychotics, and warfarin.
4. Patient complaining of nausea/vomiting prior to surgery. (PONV score 1 or more)
5. History of motion sickness/ vertigo/ Inner ear disease
6. BMI > 30 or Weight < 45kgs
7. Patient or patient’s relatives unable to understand the language employed for counselling
8. Non-consenting patient.
9. pregnant/nursing mothers.
Immediate post-operative exclusion criteria
a)Patients having severe pain [numerical rating scale (NRS)>7] in the immediate post-operative period in recovery room (RR) and requiring immediate dose of fentanyl and patients having no pain[numerical rating scale - 0].
b)Patients with vomiting post extubation or in the recovery before administration of the study drug.
c)Intra operative complications which might warrant the patient to remain intubated in the immediate post-operative period.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of PONV in patients operated for breast surgery receiving either Butorphanol or Tramadol in the immediate post-operative period |
1 , 1.5, 2, 4 to 6 and 12 to 20 hours after giving butorphanol or tramadol |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)to compare analgesic efficacy of butorphanol and tramadol with respect to reduction in pain scores and time to first rescue analgesic.
2) to compare incidence of other adverse effects including number of episodes of vomiting, sedation, respiratory depression, psychomimetic effects.
|
1 , 1.5, 2, 4 to 6 and 12 to 20 hours after giving butorphanol or tramadol |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2019 |
| Date of Study Completion (India) |
06/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/11/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Tramadol is oft used analgesic in our setup to provide analgesia for patients in the perioperative period, but the incidence of nausea and vomiting is high. Butorphanol is an agonist-antagonist, which has shown to provide effective analgesia in the operative period with lesser incidences of nausea and vomiting when used epidurally. However, literature is limited regarding intravenous use of butorphanol. Hence, we propose to compare equianalgesic doses of Intravenous Butorphanol and intravenous tramadol in patients operated for breast cancer with respect to adverse effects like nausea, vomiting and sedation and analgesic efficacy by noting the time taken for the first rescue analgesic dose.
|