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Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia.

ABSTRACT: Surgery is the first-line treatment for early, localized, or operable breast cancer. Regional anesthesia during mastectomy may offer the prevention of postoperative pain. One potential protocol is the combination of serratus anterior plane block (SAM block) with pectoral nerve block I (PECS I), but the results and potential benefits are limited. Our study compared general anesthesia with or without SAM block?+?PECS I during radical mastectomy with axillary node dissection and breast reconstruction using evaluations of pain, opioid consumption, side effects and serum levels of interleukin (IL)-1beta, IL-6 and IL-10. This is a prospective, randomized controlled trial. Fifty patients were randomized to general anesthesia only or general anesthesia associated with SAM block?+?PECS I (25 per group). The association of SAM block?+?PECS I with general anesthesia reduced intraoperative fentanyl consumption, morphine use and visual analog pain scale scores in the post-anesthetic care unit (PACU) and at 24?h after surgery. In addition, the anesthetic protocol decreased side effects and sedation 24?h after surgery compared to patients who underwent general anesthesia only. IL-6 levels increased after the surgery compared to baseline levels in both groups, and no differences in IL-10 and IL-1 beta levels were observed. Our protocol improved the outcomes of mastectomy, which highlight the importance of improving mastectomy protocols and focusing on the benefits of regional anesthesia.

SUBMITTER: Matsumoto M

PROVIDER: S-EPMC5959858 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia.

Matsumoto Marcio M Flores Eva M EM Kimachi Pedro P PP Gouveia Flavia V FV Kuroki Mayra A MA Barros Alfredo C S D ACSD Sampaio Marcelo M C MMC Andrade Felipe E M FEM Valverde João J Abrantes Eduardo F EF Simões Claudia M CM Pagano Rosana L RL Martinez Raquel C R RCR

Scientific reports 20180518 1

Surgery is the first-line treatment for early, localized, or operable breast cancer. Regional anesthesia during mastectomy may offer the prevention of postoperative pain. One potential protocol is the combination of serratus anterior plane block (SAM block) with pectoral nerve block I (PECS I), but the results and potential benefits are limited. Our study compared general anesthesia with or without SAM block + PECS I during radical mastectomy with axillary node dissection and breast reconstructi ...[more]

PMID: 29777144

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Project description:Lower extremity trauma during earthquakes accounts for the largest burden of disaster-related injuries. Insufficient pain management is common in resource-limited disaster settings, and regional anesthesia (RA) may reduce pain in injured patients beyond current standards of care. To date, no controlled trials have been conducted to evaluate the use of RA for pain management in a disaster setting.The Regional Anesthesia for Painful Injuries after Disasters (RAPID) study aims to evaluate whether regional anesthesia (RA), either with or without ultrasound (US) guidance, can reduce pain from earthquake-related lower limb injuries in a disaster setting. The proposed study is a blinded, randomized controlled equivalence trial among earthquake victims with serious lower extremity injuries in a resource-limited setting. After obtaining informed consent, study participants will be randomized in a 1:1:1 allocation to either: standard care (parenteral morphine at 0.1 mg/kg); standard care plus a landmark-guided fascia iliaca compartment block (FICB); or standard care plus an US-guided femoral nerve block. General practice humanitarian response providers who have undergone a focused training in RA will perform nerve blocks with 20 ml 0.5 % levobupivacaine. US sham activities will be used in the standard care and FICB arms and a normal saline injection will be given to the control group to blind both participants and nonresearch team providers. The primary outcome measure will be the summed pain intensity difference calculated using a standard 11-point Numerical Rating Scale reported by patients over 24 h of follow-up. Secondary outcome measures will include overall analgesic requirements, adverse events, and participant satisfaction.Given the high burden of lower extremity injuries in the aftermath of earthquakes and the currently limited treatment options, research into adjuvant interventions for pain management of these injuries is necessary. While anecdotal reports on the use of RA for patients injured during earthquakes exist, no controlled studies have been undertaken. If demonstrated to be effective in a disaster setting, RA has the potential to significantly assist in reducing both acute suffering and long-term complications for survivors of earthquake trauma.ClinicalTrials.gov ( NCT02698228 ), registered on 16 February 2016.

Project description:BackgroundMany types of regional nerve blocks have been used during anesthesia for modified radical mastectomy. In recent years, the use of pectoral nerve (PECS) block has gained importance in postoperative analgesia, but there are still controversies regarding its efficacy. There is especially no consensus on the optimal type of PECS block to be used. Herein, we attempt to evaluate the analgesic efficacy of the PECS block after radical mastectomy.MethodsWe searched PubMed, EMBASE, and the Cochrane library for randomized controlled trials (RCTs) for studies regarding PECS versus general anesthesia (GA) that were published prior to May 31, 2018. Outcome measures such as intra- and postoperative consumption of opioids, postoperative nausea and vomiting (PONV), need for postoperative rescue analgesia, and pain scores were analyzed. After quality evaluation and data extraction, a meta-analysis was performed using Review Manager 5.3 software, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used for rating the quality of evidence.ResultsA total of 8 RCTs and 2 cohort studies involving 993 patients were eligible. Compared with the GA group, the PECS block group effectively reduced the intraoperative and postoperative use of opioid drugs, incidence of PONV, need for postoperative rescue analgesia, and pain scores within 0 to 6 hours after surgery. However, subgroup analysis showed that PECS I block did not have a significant advantage in reducing the intra- and postoperative consumption of opioids. Results for each outcome indicator were confirmed as having a high or moderate level of evidence.ConclusionsEven considering the limitations (evaluations of efficacy in different age groups and for chronic pain were not carried out) of this meta-analysis, it can be concluded that the PECS II block is an effective anesthetic regimen in modified radical mastectomy that can effectively reduce the intra- and postoperative consumption of opioids, postoperative PONV, and the need for postoperative rescue analgesia and can alleviate early pain (0-6 hours) after surgery.

Project description:BACKGROUND:Seroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae. Closing the dead space after mastectomy seems to be key in reducing seroma and its complications. Various methods have been described to reduce the dead space after mastectomy: closed suction drainage, quilting of the skin flaps and application of adhesive tissue glues. The aim of this trial is to compare seroma formation and its sequelae in the various methods of flap fixation. METHODS:This is a multicenter, double-blind, randomized controlled trial in female breast cancer patients undergoing mastectomy, with or without axillary clearance. Exclusion criteria consist of breast conserving therapy, direct breast reconstruction and incapacity to comprehend implications and extent of study and unable to sign for informed consent. A total of 336 patients will be randomized. Patients will be randomly allocated to one of three treatment arms consisting of flap fixation using ARTISS tissue glue with a low suction drain, flap fixation using sutures and a low suction drain or conventional wound closure (without flap fixation) and low suction drainage. Follow up will be conducted up to twelve months post surgery. The primary outcome is the number of seroma aspirations and secondary outcomes consist of number of out patient clinic visits, surgical skin infection rate, shoulder function, cosmesis, health-related quality of life and costs and cost-effectiveness (cost/QALY). DISCUSSION:This is the first study of its kind to evaluate the effect of flap fixation and its sequelae (ie seroma aspirations, number of out patient clinic visits, infection, shoulder function, patient assessed cosmesis, quality of life and cost-effectiveness) in a double blind randomized controlled trial. TRIAL REGISTRATION:This trial was approved by the hospitals' joint medical ethical committee (14-T-21, 2 June 2014). The SAM Trial is registered in ClinicalTrials.gov since October 2017, Identifier: NCT03305757 .

Project description:BackgroundSeroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.MethodsThis is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits.DiscussionTo our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage.Trial registrationThis trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .

Project description:Background and aimTotal intravenous anesthesia (TIVA) has proven advantage over inhalational anesthesia in terms of stable hemodynamic, eco-friendly, and good recovery profile, but apprehension regarding adequate depth of anesthesia and intraoperative recall is still pertaining. This study aims to compare propofol-dexmedetomidine-based TIVA with sevoflurane-based inhalational anesthesia in modified radical mastectomy in terms of depth of anesthesia, intraoperative recall, recovery profile, and hemodynamic status.Settings and designThis prospective randomized controlled study was conducted at a tertiary care center over a time frame of 1 year.MethodologyIn this randomized controlled study, 100 patients were randomly distributed into two groups: TIVA (Group T) and inhalational anesthesia (Group I). Group T patients received injection dexmedetomidine: 1 μg.kg-1 over 10 min followed by 0.7 μg.kg-1.h-1 and injection propofol: 25-100 μg.kg-1.min-1. Ventilation was maintained with oxygen-air gas flow. In Group I, patients were ventilated with nitrous oxide-oxygen (50:50) and sevoflurane. Rest of anesthesia for both the groups was same. Primary objective was to achieve adequate depth of anesthesia as monitored by intraoperative bispectral index value (BIS, 40-60). Hemodynamic variables, recovery profile, and amount of individual anesthetic agent consumed were recorded for comparison between two groups. For comparison of scale variables between two groups, independent sample t-test for significant difference between two sample means has been followed.ResultsIntraoperative BIS and hemodynamic variables were comparable (P > 0.05). Emergence time was 5.10 min in the TIVA group versus 8.38 min in the inhalational group (P = 0.00). Modified Aldrete score was comparable in two groups (P > 0.05). Cost of TIVA agents consumed per patient was 40% lesser than inhalational agents.ConclusionTIVA maintains adequate depth of anesthesia along with stable hemodynamic and good recovery profile, at low cost in an eco-friendly manner.

Project description:BACKGROUND:The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS trial is to compare rates of intraoperative hypotension after anesthesia and to identify risk factors for intraoperative hypotension. METHODS:A total of 722 infants ?60 weeks postmenstrual age undergoing inguinal herniorrhaphy were randomized to either bupivacaine regional anesthesia (RA) or sevoflurane GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born at <26 weeks of gestation. Moderate hypotension was defined as mean arterial pressure measurement of <35 mm Hg. Any hypotension was defined as mean arterial pressure of <45 mm Hg. Epochs were defined as 5-minute measurement periods. The primary outcome was any measured hypotension <35 mm Hg from start of anesthesia to leaving the operating room. This analysis is reported primarily as intention to treat (ITT) and secondarily as per protocol. RESULTS:The relative risk of GA compared with RA predicting any measured hypotension of <35 mm Hg from the start of anesthesia to leaving the operating room was 2.8 (confidence interval [CI], 2.0-4.1; P < .001) by ITT analysis and 4.5 (CI, 2.7-7.4, P < .001) as per protocol analysis. In the GA group, 87% and 49%, and in the RA group, 41% and 16%, exhibited any or moderate hypotension by ITT, respectively. In multivariable modeling, group assignment (GA versus RA), weight at the time of surgery, and minimal intraoperative temperature were risk factors for hypotension. Interventions for hypotension occurred more commonly in the GA group compared with the RA group (relative risk, 2.8, 95% CI, 1.7-4.4 by ITT). CONCLUSIONS:RA reduces the incidence of hypotension and the chance of intervention to treat it compared with sevoflurane anesthesia in young infants undergoing inguinal hernia repair.

Dataset Information

Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia.

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Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia.

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