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66 result(s) for "Mastectomy, Modified Radical - adverse effects"
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Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial
Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects. NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤49 years, ≥50 years), clinical tumour size (≤2·0 cm, 2·1–4·0 cm, ≥4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1–126·7). This study is registered with ClinicalTrials.gov, number NCT00003830. 5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96–1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4–93·3) in group 1 and 90·3% (88·8–91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90–1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5–84·4) in group 1 and 81·5% (79·6–83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye. Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes. US Public Health Service, National Cancer Institute, and Department of Health and Human Services.
The new serratus anterior plane block is more effective than the SPB block for early postoperative analgesia following modified radical mastectomy surgery
Serratus anterior plane block (SPB) as a regional anesthesia technique is used for analgesia in modified radical mastectomy (MRM). The new serratus anterior plane (SAP) block is a novel approach that has been described recently. This study aimed to elucidate the effectiveness and safety of SAP block for pain management after MRM and compare the analgesic effects of SPB and SAP block with those of a control group during the postoperative period of MRM. In a prospective randomized controlled trial, sixty patients (n = 60) who underwent MRM surgery received either SPB or SAP block analgesia. The primary endpoint was the visual analog scale (VAS) score (at rest or with movement) at 2 h after MRM. The secondary outcomes were VAS scores at different time points (6, 12, 24 h) after MRM, stress hormone levels, and the consumption of opioid analgesics during the surgery. Sixty subjects were enrolled. The VAS scores with movement at 2 h postoperation were significantly lower in the SAP group than in the SPB group ( P  = 0.027). The patients in the SAP and SPB groups had lower VAS scores compared with the Control group at 2 and 6 h after MRM, both at rest and with movement ( P  < 0.001). The SPB and SAP blocks significantly reduced the consumption of opioid analgesics during surgery compared with the control group ( P  < 0.001). This study revealed that both SPB and SAP blocks had good postoperative analgesic effects on modified radical mastectomy surgery, reduced the consumption of opioids, and decreased the stress response during surgery compared with the control group. Compared with SPB, the SAP block may have better analgesic effects during the early postoperative period of modified radical mastectomy surgery. Trial registration : This study was registered in the Chinese Clinical Trial Registry (Date of Registration: 08/08/2021, registration number: ChiCTR2100049692).
Ultrasound-Guided Pectoral Nerve Block I and Serratus-Intercostal Plane Block Alleviate Postoperative Pain in Patients Undergoing Modified Radical Mastectomy
Simultaneous application of pectoral nerve block and serratus-intercostal plane block (SPB) is one of the most desirable multimodal analgesic strategies, with wide implementation of the enhanced recovery after surgery pathway for modified radical mastectomy (MRM). The aim of the present study was to investigate the efficacy and safety of ultrasound-guided pectoral nerve block I (PECS I) and SPB for postoperative analgesia following MRM. A randomized, prospective study. An academic medical center. A total of 61 women undergoing MRM were randomly divided into 2 groups. The control group (group C, n = 32) received general anesthesia only, whereas the PECS I + SPB treated group (group PS, n = 29) received a combination of pectoral nerve block and SPB in addition to general anesthesia. Pain scores on a visual analog scale, opioid consumption, the duration at the postanesthesia care unit, and the incidence of adverse events were lower in group PS, compared with that of the group C. Moreover, PECS I together with SPB contributed to better sleep quality and higher patient satisfaction of pain relief. This study was limited by its sample size. These results suggest that the combination of PECS I and SPB provide superior perioperative pain relief in breast cancer surgery. Pectoral nerve block, serratus-intercostal plane block, postoperative analgesia, modified radical mastectomy.
Effect of ultrasound-guided continuous erector spinae plane block on postoperative pain and inflammatory response in patients undergoing modified radical mastectomy for breast cancer: study protocol for a randomised controlled trial
Background A single injection of local anaesthetic (LA) in the erector spinae plane block (ESPB) can reduce pain after modified radical mastectomy (MRM) surgery, but the duration of analgesia is affected by the duration of the LA. The aim of this study is to investigate the effect of continuous ESPB on acute and chronic pain and inflammatory response after MRM surgery. Methods In this prospective, randomised, controlled trial, we will recruit 160 patients, aged 18–80 years, scheduled for elective MRM surgery under general anaesthesia. They will be randomly assigned to two groups: a continuous ESPB group (group E) and a sham block group (group C). Both groups of patients will have a nerve block (group C pretended to puncture) and an indwelling catheter fixed prior to surgery. Electronic pumps containing LA are shielded. The primary outcome is the total consumption of analgesic agents. The secondary outcomes include the levels of inflammation-related cytokines; the occurrence of chronic pain (post-mastectomy pain syndrome, PMPS); static and dynamic pain scores at 2, 6, 12, 24 and 48 h postoperatively; and post-operative and post-puncture adverse reactions. Discussion Analgesia after MRM surgery is important and chronic pain can develop when acute pain is prolonged, but the analgesic effect of a nerve block with a single injection of LA is limited by the duration of drug action. The aim of this trial is to investigate whether continuous ESPB can reduce acute pain after MRM surgery and reduce the incidence of chronic pain (PMPS), with fewer postoperative analgesic drug-related complications and less inflammatory response. Continuous ESPB and up to 12 months of follow-up are two innovations of this trial. Trial registration Chinese Clinical Trial Registry ( https://www.chictr.org.cn/ ) ChiCTR2200061935. Registered on 11 July 2022. This trial is a prospective registry with the following registry names: Effect of ultrasound-guided continuous erector spinae plane block on postoperative pain and inflammatory response in patients undergoing modified radical mastectomy for breast cancer.
Pectoralis-serratus interfascial plane block vs thoracic paravertebral block for unilateral radical mastectomy with axillary evacuation
The aim of this study was to evaluate the analgesic efficacy and safety of pectoralis-serratus interfascial plane block in comparison with thoracic paravertebral block for postmastectomy pain. A prospective randomized controlled study. Tertiary center, university hospital. Sixty-four adult women, American Society of Anesthesiologists physical status classes I, II, and III, scheduled for unilateral modified radical mastectomy with axillary evacuation. Patients were randomized to receive either pectoralis-serratus interfascial plane block, PS group (n=32), or thoracic paravertebral block, PV group (n=32). Twenty-four-hour morphine consumption and the time to rescue analgesic were recorded. The pain intensity evaluated by visual analog scale (VAS) score at 0, 2, 4, 8, 16, and 24hours postoperatively was also recorded. The median (interquartile range) postoperative 24-hour morphine consumption was significantly increased in PS group in comparison to PV group (PS vs PV), 20 mg (16-23 mg) vs 12 mg (10-14 mg) (P<.001). The median postoperative time to first analgesic request was significantly shorter in PS group compared to PV group (PS, 6 hours [5-7 hours], vs PV, 11 hours [9-13 hours]) (P<.001). The intensity of pain was low in both groups in VAS 0, 2, and 4hours postoperatively. However, there was significant reduction in VAS in PV group compared to PS group at 8, 16, and 24hours postoperatively. Pectoralis-serratus interfascial plane block was safe and easy to perform and decreased intensity of postmastectomy pain, but it was inferior to thoracic paravertebral block. •Paravertebral block is still the standard analgesic technique for postmastectomy pain.•Pectoralis-serratus interfascial plane block reduces postmastectomy pain for a short time.•Pectoralis-serratus interfascial plane block is easy to perform and safe analgesic technique.
The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined with Pectoral Nerve Block in Modified Radical Mastectomy: A Prospective Randomized Trial
Pectoral nerve (Pecs) block is one of the most promising regional analgesic techniques for breast surgery. However, Pecs II block may not provide analgesia of the medial aspect of the breast or the entire nipple-areolar complex. The aim of the present study was to investigate the efficacy of combining the pecto-intercostal fascial block (PIFB) and Pecs II block for perioperative analgesia following modified radical mastectomy (MRM). A prospective randomized study. An academic medical center. Sixty women undergoing unilateral MRM were randomly divided into 2 groups. The Pecs II group received Pecs II block using 20 mL bupivacaine 0.25% between the serratus anterior and the external intercostal muscles, and 10 mL bupivacaine 0.25% between the pectoralis major and minor muscles, together with sham PIFB using 15 mL normal saline solution in the interfascial plane between the pectoralis major muscle and the external intercostal muscle. PIFB-Pecs II group received the same Pecs II block combined with PIFB using 15 mL bupivacaine 0.25%. The median (interquartile range [IQR]) time to the first morphine dose was significantly longer in the PIFB-Pecs II group (327.5 [266.3-360.0] minutes) than the Pecs II group (196 [163.8-248.8] minutes) (P < 0.001, 95% confidence interval [CI] 79.98, 150.00).The median (IQR) cumulative morphine consumption was higher in the Pecs II group (14.0 [11.0-18.0] mg) than the PIFB-Pecs II group (8.0 [7.0-9.0] mg) (P < 0.001; CI, 4.0-8.0). Intraoperative consumption of fentanyl was significantly lower in PIFB-Pecs II group with a median (IQR) of 0 (0-15 mu g) than the Pecs II group median 57.5 (0-75 mu g) (P = 0.022, CI; 0-60). The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001). The dermatomal block on the lateral chest wall was comparable between the 2 studied groups. PIFB-Pecs II provided extensive sensory block on the anterior chest wall, whereas Pecs II block failed to achieve any sensory block. This study was limited by its small sample size. The combination of Pecs II and PIFB provide better perioperative analgesia for MRM than Pecs II alone.
Effect of liposomal bupivacaine combined with bupivacaine hydrochloride for transversus thoracic muscle plane block and pectoral nerves block in modified radical mastectomy for breast cancer: protocol for a randomised controlled trial
IntroductionThe incidence of acute pain subsequent to modified radical mastectomy (MRM) for breast cancer approximates 40%, with more than half of these cases evolving into chronic pain. Currently, the commonly employed analgesic schemes in clinical practice still have inadequacies. Liposomal bupivacaine (LB) is bupivacaine encapsulated in liposomes, and it is reported that its duration of action can extend up to 72 hours. This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle plane (TTP) block and pectoral nerves (PECS) block after MRM for breast cancer.Methods and analysisIn this prospective, randomised, controlled trial, we will enrol 80 female patients aged 30 to 65 years who are scheduled to undergo MRM under general anaesthesia in combination with nerve block. They will be randomly assigned in a 1:1 ratio to the LB+BHCl group (Group A) and the BHCl group (Group B). All patients will undergo ultrasound-guided TTP+PECS block prior to surgery. The primary outcomes are the cumulative pain visual analogue scale (VAS) scores from 6 to 72 hours post-surgery and the quality of recovery, assessed using the QoR-40 score at 72 hours post-surgery. The secondary outcomes include the time to first analgesic rescue, the consumption of analgesic drugs within 72 hours postoperatively, the occurrence of adverse events and the VAS scores at 6 and 12 months postoperatively.Ethics and disseminationEthical approval was obtained from the Ethics Committee of the Affiliated Hospital of Yangzhou University (2024 Ke Lun Shen (2024-07-01)). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.Trial registration numberChinese Clinical Trial Registry (ChiCTR2400089933).
The effect of ultrasound-guided serratus plane block on the quality of life in patients undergoing modified radical mastectomy and axillary lymph node dissection: a randomized controlled study
Modified radical mastectomy (MRM) and axillary lymph node dissection (AD) are the most commonly used surgical methods in breast cancer surgery, and they are characterized by moderate to severe pain. This study aimed to investigate the effect of ultrasound-guided serratus plane block (SPB) on postoperative acute and chronic pain in patients undergoing MRM and AD. After ethical approval, 60 patients, aged between 18-65 years, ASA I-III, underwent unilateral MRM, and AD was assigned into 2 groups. The SPB group received ultrasound-guided SPB with 30 mL 0.25% bupivacaine, and the control group received 2 mL saline injection subcutaneously. Postoperative analgesia was performed with intravenous patient-controlled analgesia and dexketoprofen trometamol. Pain scores, opioid consumption, and rescue analgesic requirements were recorded. Chronic pain and quality of life were evaluated with the Numerical Rating Scale (NRS), short form-36 (SF-36), and painDETECT. Compared with the control group, the visual analogue scale scores were statistically lower in the SPB group during 4 postoperative hours in post-anaesthetic care unit PACU at 1st, 2nd (P < 0.001), and 4th hour (P = 0.014). Fentanyl consumption and rescue analgesics were lower in the SPB group than in the control group (0-4 h, P = 0.001; 4-8 h, 8-12 h, 24 h; total P < 0.001). The incidence of chronic pain was 11%, and there was no statistically significant difference between control and SPB groups in terms of SF-36, NRS, and painDETECT scores measured at the first and sixth months. SPB demonstrated superiority versus the control group concerning acute postoperative pain parameters. However, SPB had no influence on the quality of life and did not prevent chronic postmastectomy pain.
Effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage in modified radical mastectomy: a randomized trial
Background This study investigated the effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage. Methods In this randomized, single-blinded, prospective study, 120 patients undergoing unilateral modified radical mastectomy were randomly assigned to the treatment group (T group, n  = 60) or control group (C group, n  = 60). In the T group, patients received both IoC1 (sedation) and IoC2 (analgesia) monitoring, and remifentanil dosages were adjusted by anesthetists according to IoC2. In the C group, remifentanil dosages were adjusted based on the anesthetists’ judgment according to the patients’ vital signs. Remifentanil dose, adjustment frequency, infusion duration, intraoperative adverse events, and quality of anesthetic recovery were compared between the two groups. The primary outcome was the dose of remifentanil. Results Compared with the C group, mean remifentanil dosage was significantly higher in the T group (3.8 ± 1.9 versus 3.2 ± 1.2 μg kg -1 h -1 , P  < 0.05) during the anesthetic period, as was the adjustment frequency of target-controlled infusion (2.9 ± 1.9 versus 2.0 ± 1.2 times/surgery, P  < 0.05), but there was no difference in infusion duration. Voluntary eye opening, extubation time, and recovery score were not significantly different between the two groups ( P  > 0.05). Total adverse events were significantly reduced in the T group ( P  < 0.05). Conclusions IoC1-targeted propofol dosing does not seem to be significantly different to hemodynamic-based monitoring, whereas IoC2 monitoring can increase remifentanil dosage during modified radical mastectomy, but the anesthetic process is more controllable and total adverse events are reduced, which improves the controllability of anesthesia. Trial registration Trial registration number: ChiCTR-TRC-13004101 , registered on 27 November 2013.
Shoulder Movement After Breast Cancer Surgery: Results of a Randomised Controlled Study of Postoperative Physiotherapy
Breast screening programmes have facilitated more conservative approaches to the surgical and radiotherapy management of women diagnosed with breast cancer. This study investigated changes in shoulder movement after surgery for primary, operable breast cancer to determine the effect of elective physiotherapy intervention. Sixty-five women were randomly assigned to either the treatment (TG) or control group (CG) and assessments were completed preoperatively, at day 5 and at 1 month, 3, 6, 12 and 24 months postoperatively. The CG only received an exercise instruction booklet in comparison to the TG who received the Physiotherapy Management Care Plan (PMCP). Analyses of variance revealed that abduction returned to preoperative levels more quickly in the TG than in the CG. The TG women had 14 degrees more abduction at 3 months and 7 degrees at 24 months. Functional recovery at 1 month was greater in those randomised to the TG, with a dominant operated arm (OA) or receiving breast-conserving surgery. However, it was not possible to predict recovery over the 2 years postoperatively on the basis of an individual woman's recovery at 1 month postoperatively. The eventual recovery of abduction or flexion range of movement was not related to the dominance of the OA nor to the surgical procedure performed. The PMCP provided in the early postoperative period is effective in facilitating and maintaining the recovery of shoulder movement over the first 2 years after breast cancer surgery.