RESUMO
BACKGROUND: Endovenous laser ablation (EVLA) using tumescent anesthesia for treatment of an insufficient great saphenous vein (GSV) can be painful and require intravenous pain management and, sometimes, sedation with propofol. Femoral nerve blockade (FNB) anesthetizes the femoral nerve distribution and is usually used for anterior thigh and knee procedures. It is easy to inject with ultrasound guidance because the nerve is easy to visualize in the groin. The aim of the present double-blind, randomized controlled trial was to determine whether FNB before tumescent anesthesia decreases the pain of GSV EVLA combined with local phlebectomy. METHODS: Eighty patients who underwent GSV EVLA combined with local phlebectomy under tumescent anesthesia were randomized into two groups. The placebo group (control group; 40 patients) was given placebo FNB with 0.9% saline before tumescent injection. The FNB group (intervention group; 40 patients) received 1% lidocaine with adrenaline for FNB before tumescent injection. Only the study nurse, who performed the randomization, knew which patients were in which group. The patients and operating surgeon were unaware of the randomization group. FNB was performed under ultrasound guidance. The effectiveness of anesthesia was tested 10 minutes after injection using the pin-prick test and a numeric rating scale (NRS). The NRS was completed before and during tumescent anesthesia and during EVLA ablation and local phlebectomy. The motor function of the femoral nerve was tested at the end of the procedure and 1 hour after using the Bromage method. Patients had a follow-up visit 1 month after the procedure, and their need for pain medication and the duration of sick leave were recorded. RESULTS: No differences were found in the gender distribution, age, or GSV dimensions at baseline. The mean length of the treated GSV segment was 28 cm and 30 cm and the mean energy used was 1911 J and 2059 J in the placebo and FNB groups, respectively. The median NRS score for pain during tumescent injection around the GSV was 2 (interquartile range [IQR], 1-4) in the placebo group compared with 1 (IQR, 1-3) in the FNB group. Very little pain was experienced during laser ablation. The median NRS score was 0 (IQR, 0-0) and 0 (IQR, 0-0.75) in the placebo and FNB groups, respectively. The most painful stage was injection of tumescence to the local phlebectomy sites in both groups. The median NRS score was 4 (IQR, 3-7) in the placebo group and 2 (IQR, 1-4) in the FNB group (P = .01). During local phlebectomy, the NRS score was 2 (IQR, 0-4) vs 1 (IQR, 0-3) in the placebo and FNB groups, respectively. Only the difference in pain during injection of tumescence before local phlebectomy was significant. CONCLUSIONS: FNB seems to decrease pain during EVLA combined with local phlebectomy. Patients experienced the highest pain when tumescence was injected before local phlebectomy, and those in the FNB group experienced significantly less pain than the placebo group. No indication for routine use of FNB is indicated. However, it could be used to decrease the pain for patients who experience strong pain during varicose vein surgery, especially if extensive local phlebectomies are required.
Assuntos
Terapia a Laser , Bloqueio Nervoso , Varizes , Insuficiência Venosa , Humanos , Varizes/diagnóstico por imagem , Varizes/cirurgia , Varizes/complicações , Analgésicos Opioides , Resultado do Tratamento , Veia Safena/diagnóstico por imagem , Veia Safena/cirurgia , Terapia a Laser/efeitos adversos , Dor/etiologia , Bloqueio Nervoso/efeitos adversos , Insuficiência Venosa/diagnóstico por imagem , Insuficiência Venosa/cirurgia , Insuficiência Venosa/complicaçõesRESUMO
BACKGROUND: Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution. METHODS: Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data. RESULTS: A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the paclitaxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mortality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively). CONCLUSIONS: No significant difference was seen in the overall analysis between the paclitaxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individual trials are small and should be interpreted in the context of future patient-level meta-analysis.
Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Dispositivos de Acesso Vascular , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Fármacos Cardiovasculares/efeitos adversos , Finlândia , Humanos , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
With the growing number of diabetics and patients with multiple problems vascular access surgery increases and therapies become more challenging. If haemodialysis is the therapy of choice for renal failure, veins of the patient's upper limbs should be preserved. Autologic fistula of the upper limb--most commonly between the radial artery and the cephalic vein--is the best option with the lowest complication risks. The purpose of vascular access surgery is to reconstruct and maintain the function of a vascular access, in collaboration with nephrologists and radiologists. To achieve this the nursing and medical personnel should be educated to use dupplex ultrasound in the diagnosis of malfunctioning accesses and needling problems during haemodialysis.