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.

Completed

• Conditions: Malignant neoplasm of breast,

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

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-11
• Study Start: 2019-12-08
• Last Update Posted: 2020-04-23

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• 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 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.

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 period	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.	2) to compare incidence of other adverse effects including number of episodes of vomiting, sedation, respiratory depression, psychomimetic effects.

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Kailash Sharma

Principal investigator

912224177000

girish.nandan@gmail.com