Manoj Kumar Karmakar1, Winnie Samy1, Anna Lee1, Jia Wei Li1, Wing Cheong Chan2, Phoon Ping Chen3, Ban C H Tsui4. 1. Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, P.R. China. 2. Department of Surgery, North District Hospital, Sheung Shui, New Territories, Hong Kong, P.R. China. 3. Departments of Anesthesiology and Operating Services, North District Hospital, Sheung Shui, New Territories, Hong Kong, P.R. China. 4. Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, U.S.A. bantsui@stanford.edu.
Abstract
AIM: This 5-year prospective follow-up of women randomized to general anesthesia (GA) with or without a thoracic paravertebral block (TPVB) examined the risk of local recurrence, metastasis and mortalityafter breast cancer surgery. PATIENTS AND METHODS: A total of 180 patients undergoingmodified radical mastectomy were randomized to one of three study groups: standardized GA only; GA with a single-injection TPVB (s-TPVB) and placebo paravertebral infusion after surgery for 72-h; and GA plus with continuous TPVB (c-TPVB) for 72-h postoperatively. Cox proportional models were used to assess the effect of TPVB on long-term outcomes. Equivalence testing was used to help interpret the results. RESULTS: The incidence [95% confidence interval (CI)] of cancer recurrence, metastatic spread and all-cause mortality was 2.3% (0.7-5.4%), 7.9% (4.6-12.6%) and 6.8% (3.6-11.2%), respectively. Four women had cancer recurrence and had metastatic spread. Compared to the GA-only group, the risk of metastatic spread was not different from that of GA with s-TPVB [hazard ratio (HR)=1.11, 95% CI=0.32-3.83) nor from that with GA plus c-TPVB (HR=0.79, 95% CI=0.21-2.96) (p=0.88). Compared to the GA-only group, the risk of mortality was similarly not different from that of the two other groups (HR=2.57, 95% CI=0.66-9.92; and HR=0.66, 95% CI=0.11-3.97, respectively, p=0.15). CONCLUSION: Although the original study was underpowered to properly address long-term outcomes, the results of this analysis suggest that TPVB, administered whether as a single-injection or continuous infusion during the perioperative period, had little to no appreciable effect on local recurrence, metastasis or mortalityafter breast cancer surgery. Copyright
RCT Entities:
AIM: This 5-year prospective follow-up of women randomized to general anesthesia (GA) with or without a thoracic paravertebral block (TPVB) examined the risk of local recurrence, metastasis and mortality after breast cancer surgery. PATIENTS AND METHODS: A total of 180 patients undergoing modified radical mastectomy were randomized to one of three study groups: standardized GA only; GA with a single-injection TPVB (s-TPVB) and placebo paravertebral infusion after surgery for 72-h; and GA plus with continuous TPVB (c-TPVB) for 72-h postoperatively. Cox proportional models were used to assess the effect of TPVB on long-term outcomes. Equivalence testing was used to help interpret the results. RESULTS: The incidence [95% confidence interval (CI)] of cancer recurrence, metastatic spread and all-cause mortality was 2.3% (0.7-5.4%), 7.9% (4.6-12.6%) and 6.8% (3.6-11.2%), respectively. Four women had cancer recurrence and had metastatic spread. Compared to the GA-only group, the risk of metastatic spread was not different from that of GA with s-TPVB [hazard ratio (HR)=1.11, 95% CI=0.32-3.83) nor from that with GA plus c-TPVB (HR=0.79, 95% CI=0.21-2.96) (p=0.88). Compared to the GA-only group, the risk of mortality was similarly not different from that of the two other groups (HR=2.57, 95% CI=0.66-9.92; and HR=0.66, 95% CI=0.11-3.97, respectively, p=0.15). CONCLUSION: Although the original study was underpowered to properly address long-term outcomes, the results of this analysis suggest that TPVB, administered whether as a single-injection or continuous infusion during the perioperative period, had little to no appreciable effect on local recurrence, metastasis or mortality after breast cancer surgery. Copyright
Authors: Gustavo N C Inoue; Ruan Pimenta; Juliana A Camargo; Nayara I Viana; Vanessa R Guimarães; Miguel Srougi; William C Nahas; Katia R M Leite; Sabrina T Reis Journal: Ann Med Surg (Lond) Date: 2022-02-24