Dataset Information

A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection.

ABSTRACT:

Background

The effect of local infiltration after breast surgery is controversial. This prospective double blind randomized study sought to document the analgesic effect of local anaesthetic infiltration after breast cancer surgery.

Methods

Patients scheduled for mastectomy or tumorectomy and axillary nodes dissection had immediate postoperative infiltration of the surgical wound with 20 ml of ropivacaine 7.5 mg.ml-1 or isotonic saline. Pain was assessed on a visual analogue scale at H2, H4, H6, H12, H24, H72, and at 2 month, at rest and on mobilization of the arm. Patient'comfort was evaluated with numerical 0-3 scales for fatigue, quality of sleep, state of mood, social function and activity.

Results

Twenty-two and 24 patients were included in the ropivacaine and saline groups respectively. Postoperative pain was lower at rest and on mobilization at 2, 4 and 6 hour after surgery in the ropivacaine group. No other difference in pain intensity and patient 'comfort scoring was documented during the first 3 postoperative days. Patients did not differ at 2 month for pain and comfort scores.

Conclusion

Single shot infiltration with ropivacaine transiently improves postoperative pain control after breast cancer surgery.

Trial registration number

NCT01404377.

SUBMITTER: Vigneau A

PROVIDER: S-EPMC3239295 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection.

Vigneau Axelle A Salengro Anne A Berger Joelle J Rouzier Roman R Barranger Emmanuel E Marret Emmanuel E Bonnet Francis F

BMC anesthesiology 20111124

<h4>Background</h4>The effect of local infiltration after breast surgery is controversial. This prospective double blind randomized study sought to document the analgesic effect of local anaesthetic infiltration after breast cancer surgery.<h4>Methods</h4>Patients scheduled for mastectomy or tumorectomy and axillary nodes dissection had immediate postoperative infiltration of the surgical wound with 20 ml of ropivacaine 7.5 mg.ml-1 or isotonic saline. Pain was assessed on a visual analogue scale ...[more]

PMID: 22114900

Similar Datasets

Project description:PurposeSalvage mastectomy is traditionally recommended for patients who developed ipsilateral breast tumor recurrence (IBTR) in light of previous breast irradiation. However, it remains controversial whether surgical axillary staging (SAS) is necessary for IBTR patients with negative nodes. This study aimed to evaluate the oncologic safety of omitting SAS for IBTR.MethodsWe retrospectively identified patients who developed invasive IBTR with negative nodes after undergoing breast-conserving surgery (BCS) from 2010 to 2018. Patterns of care in nodal staging were analyzed based on prior axillary staging status. Clinicopathologic characteristics and adjuvant treatment of the initial tumor, as well as the IBTR, were compared between the SAS and no SAS groups. Kaplan-Meier method and Cox regression model were utilized to compare the locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and overall survival (OS) rates after IBTR removal between the two groups.ResultsA total of 154 IBTR patients were eligible for final analysis. Compared to the no SAS group, SAS group was less likely to undergo ALND (15.1 vs 73.3%, p < 0.001) at initial BCS, had a longer recurrence interval (2.8 vs 2.1 years, p = 0.03), and were more likely to have discordant molecular subtype (35.8 vs 12.9%, p = 0.001) and different quadrant location (37.7 vs 19.8%, p = 0.02) with primary tumor. However, the extent of axillary staging did not affect systemic or radiation recommendations. In the subgroup of patients without previous ALND, the clinicopathologic characteristics were roughly comparable. No significant differences were observed in LRRFS, DMFS or OS between the two groups.ConclusionFor node-negative IBTR patients, we observed selection bias on the basis of prior ALND, shorter recurrence interval, and concordant molecular subtype favoring no SAS but comparable LRRFS, DMFS, and OS. These results support a wider consideration of sparing SAS in the management of IBTR, especially in patients without previous ALND.

Project description:IntroductionBreast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects.Methods and analysesThis multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival.DiscussionThis study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity.Ethics and disseminationThe Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Trial registrationClinicalTrials.gov, identifier number NCT04889924.

Project description:BackgroundThe ACOSOG Z0011 study has shown that axillary lymph node dissection (ALND) is an option to be considered in patients who had 1-2 metastatic sentinel lymph nodes (SLNs) who proceed with breast-conserving along with postoperative radiotherapy. However, there remains controversy regarding the applicability of this approach in patients who had a mastectomy. The aim of our study is to determine the prognostic differences and risk factors associated with the decision to opt for ALND in breast cancer patients who had 1-2 metastatic SLNs who receive a mastectomy.MethodsThe study conducted a retrospective analysis of patients diagnosed with cT1-2N0 breast cancer and treated at The Fourth Hospital of Hebei Medical University between January 2016 and December 2021, and patients were divided into two cohorts according to whether ALND was performed after sentinel lymph node biopsy (SLNB): SLNB cohort and SLNB + ALND cohort. Outcomes included the locoregional recurrence rate (LRR), disease-free survival (DFS), and overall survival (OS). Propensity score matching (PSM) was conducted to ensure the balance of variables between the two cohorts. Cox proportional hazard models were employed to ascertain the univariate and multivariate relative risks associated with survival.ResultsThere were 812 cases enrolled. After the PSM, 234 receiving ALND and 234 not receiving ALND were matched. A median follow-up period of 56.72 ± 20.29 months was observed. During that time, no significant difference was identified in the DFS and OS in the SLNB + ALND cohort and the SLNB cohort (P = 0.208 and P = 0.102), except for those under 40 years old, SLNB + ALND group showed a reduction in LRR compared to SLNB group (11.1% vs. 2.12%, P = 0.044). Multivariate Cox analysis showed that younger (≤ 40 years), progesterone receptor (PR)-negative, and SLNB alone were independent risk factors for LRR; perineural invasion was a risk factor, while endocrinotherapy was a beneficial prognostic indicator for DFS and OS among patients with positive hormone receptor.ConclusionALND does not impact DFS and OS in patients with 1-2 metastatic SLNs who have completed a mastectomy. Being younger (≤ 40 years), having a negative PR, and undergoing SLNB alone were independent risk factors for LRR. Given this finding, we recommend avoiding axillary treatment such as ALND or radiotherapy in patients without risk factors.

Dataset Information

A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection.

Background

Methods

Results

Conclusion

Trial registration number

Publications

A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets