Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Intravenous Butorphanol: Butorphanol, an agonist-antagonist opioid has been used in perioperative pain management. Available literature shows that butorphanol causes effective pain reli
Sponsors
Tata memorial hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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]
Exclusion criteria
Exclusion criteria: 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 7. Patient or patientâ??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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence of PONV in patients operated for breast surgery receiving either Butorphanol or Tramadol in the immediate post-operative periodTimepoint: 1 , 1.5, 2, 4 to 6 and 12 to 20 hours after giving butorphanol or tramadol | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 1 , 1.5, 2, 4 to 6 and 12 to 20 hours after giving butorphanol or tramadol | — |
Countries
India
Contacts
Public ContactDr Girish Kanna
Tata Memorial Hospital
Outcome results
None listed