ABSTRACT
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 75âyears. Four were excluded. INTERVENTIONS: All underwent general anaesthesia. The intervention group received a bolus of 0.5âmgâkg-1 of esmolol over 10âmin followed by a continuous infusion of 100âµgâkg-1âmin-1. The placebo group received saline. MAIN OUTCOME MEASURES: The primary outcome was pain at rest 24âh after mastectomy as measured by a 0 to 10 numeric rating scale. RESULTS: Pain scores at rest 24âh after mastectomy were lower in esmolol-treated patients compared with placebo (mean differenceâ=â-1.51, 95% confidence interval (CI), -2.36 to -0.65, Pâ=â0.001). On arrival in the postanaesthesia care unit (PACU), the occurrence of pain was also lower in the esmolol group, at rest and on effort (Pâ=â0.009 and Pâ=â0.013, respectively), on discharge from PACU (Pâ=â0.009 and Pâ=â0.015), 12âh (Pâ=â0.01 and Pâ=â0.007) and on effort in the 24 postoperative hours (Pâ=â0.003). Mean morphine consumption was reduced by 77% in the esmolol group compared with the placebo group (mean differenceââ=â-2.52âmg, 95% CIâ=â-3.67 to -1.38, Pâ<â0.001). The length of hospital stay was shorter for the esmolol group (mean differenceâ=â-6.9âh, 95% CI, -13.4 to -0.31, Pâ=â0.040). 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.
Subject(s)
Breast Neoplasms , Analgesics, Opioid , Brazil , Double-Blind Method , Female , Humans , Mastectomy/adverse effects , Pain, Postoperative/diagnosis , Pain, Postoperative/drug therapy , Pain, Postoperative/etiology , PropanolaminesABSTRACT
BACKGROUND: Recently, the use of venous adjuvants, such as lidocaine and magnesium sulfate, has been gaining ground in multimodal analgesia. However, no study has evaluated the impact a combination of the two drugs. OBJECTIVES: To evaluate the efficacy of venous adjuvants in reducing opioid consumption and pain scores after mastectomy. DESIGN: Randomised, double-blind, parallel-group, noninferiority clinical trial with a 1â:â1â:â1â:â1 allocation ratio. SETTING: Hospital de Base do Distrito Federal, Brasilia, Federal District, Brazil from November 2014 to December 2017. PATIENTS: One-hundred and ninety-eight patients were electively scheduled for mastectomy. Seventy-eight were excluded. INTERVENTIONS: Intra-operative infusions of remifentanil (0.1âµgâkgâmin), lidocaine (3âmgâkgâh), magnesium sulfate (50âmgâkgâ+â15âmgâkgâh) or lidocaine with magnesium sulfate were used. All patients received standard general anaesthesia. MAIN OUTCOME MEASURES: Peri-operative opioid consumption and pain scores. RESULTS: The patients who received both lidocaine and magnesium sulfate group (n=30) consumed less alfentanil during surgery (Pâ<â0.001) and less dipyrone (Pâ<â0.001) and morphine (Pâ<â0.001) in the postoperative period. Only two patients (6.7%) in the lidocaine and magnesium sulfate group needed morphine (Pâ<â0.001). These requirements were significantly lower when compared with patients who received remifentanil (n=30; 76.6%) and magnesium sulfate (n=30; 70%; odds ratio 46.0, 95% confidence interval 8.69 to 243.25, Pâ<â0.001, and odds ratio 32.66, 95% confidence interval 6.37 to 167.27, Pâ<â0.001, respectively). The patients of the lidocaine and magnesium sulfate group had lower pain scores in the first 24âh postoperatively using the numerical rating scale and verbal rating scale at discharge from the postanaesthesia care unit (Pâ<â0.001), after 12âh (Pâ<â0.001) and after 24âh (Pâ<â0.001) when compared with the other three groups. CONCLUSION: Our findings suggest a synergistic effect of the use of both lidocaine and magnesium in peri-operative pain. This may be another potential strategy in the multimodal analgesia regimen. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02309879.
Subject(s)
Breast Neoplasms , Magnesium Sulfate , Analgesics, Opioid , Anesthetics, Local , Brazil , Double-Blind Method , Humans , Lidocaine , Mastectomy , Morphine , Pain, Postoperative/diagnosis , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & controlABSTRACT
OBJECTIVES: Pectoserratus plane block (PSPB) leads to lower postoperative pain intensity. We examined whether PSPB could also reduce the incidence of post-mastectomy pain syndrome (PMPS) in women undergoing breast cancer surgery. METHODS: We performed an extension study of a randomized trial that compared PSPB versus control in women undergoing mastectomy. The primary outcome was any chronic pain at the surgical site or adjacent areas, defined as persistent/recurrent pain lasting ≥3 months. Secondary outcomes included neuropathic pain (score ≥4 in the Douleur Neuropathique 4 questionnaire), use of analgesic/anti-inflammatory drugs, pain intensity through the short-form McGill Pain Questionnaire, and type, frequency, and location of the pain. RESULTS: Of the 60 patients that completed the 24-hour follow-up (short-term trial), 53 (88%) completed the long-term follow-up (27 in the PSPB group and 26 in the placebo group). Six of 27 patients (22%) in the PSPB group and 17 of 26 patients (65%) in the placebo group reported any chronic pain (relative risk [RR], 0.34; 95% confidence interval [95% CI]=0.16-0.73, P =0.005). The risk of neuropathic pain was also lower in the PSPB group than in the placebo group (18.5% vs. 54%, respectively; RR, 0.34; 95% CI=0.14-0.82, P =0.02). There were no differences regarding all other pain-related outcomes considering the patients who developed PMPS. DISCUSSION: The results suggest that, in the long term, PSPB-treated participants were associated with a statistically significantly lower risk of PMPS than those who received standard general anesthesia. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03966326).