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.

Not Applicable

Completed

• Conditions: Health Condition 1: C50- Malignant neoplasm of breast

• Registration Number: CTRI/2019/08/020581
• Lead Sponsor: Tata memorial hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1)to compare analgesic efficacy of butorphanol and tramadol with respect to reduction in pain scores and time to first rescue analgesic. <br/ ><br>2) to compare incidence of other adverse effects including number of episodes of vomiting, sedation, respiratory depression, psychomimetic effects. <br/ ><br>Timepoint: 1 , 1.5, 2, 4 to 6 and 12 to 20 hours after giving butorphanol or tramadol