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Intra-operative esmolol and pain following mastectomy: A randomised clinical trial
Fabrício T Mendonça1, Alex J Tramontini, Henrique I Miake
1From the Department of Anaesthesiology, Base Hospital of the Federal District, Brasilia, DF (FTM, AJT, HIM, LFS) and Cardiology Department, State University of Campinas (Unicamp), Campinas, Sao Paulo, Brazil (LSFdC, ACS).
Background:
Esmolol is a beta-1 selective blocker that has been shown to reduce postoperative pain. Its antinociceptive effects have not been tested following mastectomy.
Objective:
To evaluate the safety, efficacy and antinociception of intra-operative esmolol infusion after mastectomy.
Design:
Randomised, double-blinded, placebo-controlled trial.
Setting:
Tertiary referral centre, Brasília, Brazil. Recruitment: July 2015 to July 2017.
Patients:
Seventy women scheduled for mastectomy, ASA I to III, aged 18 to 75 years. Four were excluded.
Interventions:
All underwent general anaesthesia. The intervention group received a bolus of 0.5 mg kg-1 of esmolol over 10 min followed by a continuous infusion of 100 μg kg-1 min-1. The placebo group received saline.
Main Outcome Measures:
The primary outcome was pain at rest 24 h after mastectomy as measured by a 0 to 10 numeric rating scale.
Results:
Pain scores at rest 24 h after mastectomy were lower in esmolol-treated patients compared with placebo (mean difference = -1.51, 95% confidence interval (CI), -2.36 to -0.65, P = 0.001). On arrival in the postanaesthesia care unit (PACU), the occurrence of pain was also lower in the esmolol group, at rest and on effort (P = 0.009 and P = 0.013, respectively), on discharge from PACU (P = 0.009 and P = 0.015), 12 h (P = 0.01 and P = 0.007) and on effort in the 24 postoperative hours (P = 0.003). Mean morphine consumption was reduced by 77% in the esmolol group compared with the placebo group (mean difference = -2.52 mg, 95% CI = -3.67 to -1.38, P < 0.001). The length of hospital stay was shorter for the esmolol group (mean difference = -6.9 h, 95% CI, -13.4 to -0.31, P = 0.040).
Conclusion:
Esmolol was well tolerated, allowed a notable reduction in the dose of rescue analgesics and demonstrated superior efficacy compared to placebo for pain management after mastectomy.
Trial Registration:
ClinicalTrials/NCT02466542.
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