Quality of Life after Surgery for Varicose Veins and the Impact of Preoperative Duplex: Results Based on a Randomized Trial

In a prospective randomized study, we found that the addition of a preoperative duplex scan before varicose vein (VV) surgery reduced recurrences and reoperations after 2 years. The aim of the present study was to investigate whether this correlates with an improved quality of life (QoL). We studied 293 patients scheduled for VV surgery with or without preoperative duplex. QoL was assessed preoperatively at 1 month, 1 year, and 2 years with the Short Form-36 (SF-36). Scores were compared with matched reference groups from the Swedish population. The 237 complete responders (81%) had a mean age of 47 (range 22-73) years, 169 (71%) were women, and 43 (18%) had skin changes. Both groups of VV patients scored significantly worse than the reference group in the domain Bodily Pain preoperatively (p < 0.001) and better after 1 year (p = 0.04), with no difference found after 2 years. There was no significant difference in QoL between the duplex and control groups at any time. We conclude that preoperative duplex before VV surgery did not significantly improve QoL after 2 years in spite of improved surgical results. VV surgery per se improved QoL as measured with the SF-36.     

Effect of Postoperative Epidural Analgesia on Rehabilitation and Pain after Hip Fracture Surgery: A Randomized, Double-blind, Placebo-controlled Trial

Background: Hip fracture surgery usually carries a high demand for rehabilitation and a significant risk of perioperative morbidity and mortality. Postoperative epidural analgesia may reduce morbidity and has been shown to facilitate rehabilitation in elective orthopedic procedures. No studies exist on the effect of postoperative epidural analgesia on pain and rehabilitation after hip fracture surgery.

Methods: Sixty elderly patients were included in a randomized, double-blind study comparing 4 days of continuous postoperative epidural infusion of 4 ml/h bupivacaine, 0.125%, and 50 [mu]g/ml morphine versus placebo. Both patient groups received balanced analgesia and intravenous nurse-controlled analgesia with morphine. All patients followed a well-defined multimodal rehabilitation program. Pain, ability to participate in four basic physical functions, and any factors restricting participation were assessed on the first 4 postoperative days during physiotherapy.

Results: Epidural analgesia provided superior dynamic analgesia during all basic physical functions, and patients were significantly less restricted by pain, which was the dominating restricting factor in the placebo group. Motor blockade was not a restricting factor during epidural analgesia. Despite improved pain relief, scores for recovery of physical independence were not different between groups.     

Intraoperative Epidural Analgesia Prevents the Early Proinflammatory Response to Surgical Trauma. Results from a Prospective Randomized Clinical Trial of Intraoperative Epidural Versus General Analgesia

Background  

The intraoperative epidural analgesia (EA) has the potential to reduce stress response to surgical trauma which induces a transient immunoactivation that has a negative impact on the outcome. This study investigates the effect of intraoperative EA versus intravenous analgesia (IA) on the immune function.     

Continuous Paravertebral Analgesia versus Continuous Epidural Analgesia after Video- Assisted Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial

Background: Whether continuous thoracic epidural analgesia (TEA) and continuous paravertebral block (PVB) have similar analgesic effects in patients undergoing video- assisted thoracic surgery (VATS) lobectomy was compared in this study.Methods: In all, 86 patients undergoing VATS lobectomy were enrolled in the prospective, randomized clinical trial. Group E received TEA. Group P received PVB. The primary endpoint was postoperative 24-hour visual rating scale (VAS) on coughing. Side effects and postoperative complications were also analyzed.Results: Pain scores at rest or on coughing at 24 and 48 h postoperatively were significantly lower in group E than in group P (P <0.05). At 24 h postoperatively, more patients in group E suffered from vomiting (32.6% vs 11.6%, P = 0.019), dizziness (55.8% vs 12.9%, P = 0.009), pruritus (27.9% vs 2.3%, P = 0.002), and hypotension (32.6% vs 4.7%, P = 0.002) than those in group P. Patients in group E were more satisfied (P = 0.047). Four patients in group P and two patients in group E suffered from pulmonary complications (P >0.05). The length of hospital and intensive care unit (ICU) stays were not significantly different.Conclusions: Though TEA has more adverse events than PVB, it may be superior to PVB in patients undergoing VATS lobectomy.     

Cesarean Delivery: A Randomized Trial of Epidural versus Patient-controlled Meperidine Analgesia during Labor

Background: Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries. However, only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery. The authors' primary purpose in this randomized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative: patient-controlled intravenous analgesia.

Methods: Seven hundred fifteen women of mixed parity in spontaneous labor at full term were randomly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia. Epidural analgesia was maintained with a continuous epidural infusion of 0.125% bupivacaine with 2 micro gram/ml fentanyl. Patient-controlled analgesia was maintained with 10-15 mg meperidine given every 10 min as needed using a patient-controlled pump. Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman randomized in the study.

Results: A total of 358 women were randomized to receive epidural analgesia, and 243 (68%) of these women complied with the epidural analgesia protocol. Similarly, 357 women were randomized to receive patient-controlled intravenous meperidine analgesia, and 259 (73%) of these women complied with the patient-controlled intravenous analgesia protocol. Only five women who were randomized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief. There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original randomization (epidural analgesia, 4% [95% CI: 1.9-6.2%] compared with patient-controlled intravenous analgesia, 5% [95% CI: 2.6-7.2%]). Similar results were observed for the analysis of the protocol-compliant groups (epidural analgesia, 5% [95% CI: 2.6-8.5%] compared with patient-controlled intravenous analgesia, 6% [95% CI: 3-8.9%]). Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia.     

Health-related Quality of Life for Abiraterone Plus Prednisone Versus Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer: Results from a Phase II Randomized Trial

BackgroundAbiraterone and enzalutamide are associated with side effects that may impair health-related quality of life (HRQoL).ObjectiveTo assess patient-reported HRQoL, depression symptoms, and cognitive function for abiraterone versus enzalutamide.Design, setting, and participantsWe randomized 202 patients in a phase II study of abiraterone versus enzalutamide for first-line treatment of metastatic castration-resistant prostate cancer (ClinicalTrials.gov: NCT02125357).InterventionPatients completed Functional Assessment of Cancer Therapy—Prostate (FACT-P) and Patient Health Questionnaire-9 (PHQ-9) questionnaires, and Montreal Cognitive Assessment (MoCA) cognitive assessments at baseline and on treatment.Outcome measurements and statistical analysisTo compare the change in FACT-P scores over time between treatment arms, we used a mixed model for repeated measures (MMRM). For FACT-P domains where there was an interaction between the treatment arm and age, we constructed separate models for patients aged <75 and ≥75 yr. We compared the proportion of patients with clinically meaningful change from baseline for FACT-P, and the proportion of patients with an abnormal score and median change from baseline for PHQ-9 and MoCA using Fisher's exact test and Mann-Whitney U test.Results and limitationsIn the MMRM analysis, there was a positive test for interaction in the treatment arm by age for total FACT-P (p = 0.048). FACT-P change from baseline over time was better for abiraterone than for enzalutamide in the ≥75-yr model (p = 0.003), with no difference in the <75-yr model (p > 0.9). A higher proportion of patients experienced clinically meaningful worsening with enzalutamide for the physical and functional well-being domains (37% vs 21%, p = 0.013; 39% vs 23%, p = 0.015). The distribution of change in PHQ-9 scores from baseline favored abiraterone at weeks 4, 8, and 12. These analyses were not prespecified, and results should be considered to be hypothesis generating.ConclusionsPatient-reported outcomes favored abiraterone compared with enzalutamide with differences in FACT-P HRQoL and PHQ-9 depression scores. Differences in the total FACT-P scores were seen only in the elderly patient subgroup.Patient summaryIn this report, we examined the change in patient-reported quality-of-life scores from the start of treatment over time for patients treated with abiraterone versus enzalutamide for metastatic castration-resistant prostate cancer. We found that elderly patients treated with abiraterone had better quality of life over time, with no difference between treatments for the younger subgroup of patients.     

Health-Related Quality of Life after Colonic Resection for Diverticular Disease: Long-term Results

Background and Aims  While colonic resection is standard practice in complicated colonic diverticular disease (DD), treatment of uncomplicated diverticulitis is, as yet, unclear. The aim of the present study was to evaluate the long-term clinical outcome and quality of life in DD patients undergoing colonic resection compared to those receiving medical treatment only. Patients and Methods  Seventy-one consecutive patients who were admitted to our surgical department with left iliac pain and endoscopical or radiological diagnosis of DD were enrolled in this trial. Disease severity was assessed with Hinchey scale. Twenty-five of the patients underwent colonic resection, while 46 were treated with medical therapy alone. After a median follow-up of 47 (3–102) months from the time of their first hospital admission, the patients responded to the questions of the Cleveland Global Quality of Life (CGQL) questionnaire and to a symptoms questionnaire during a telephone interview. Admittance and surgical procedures for DD were also investigated, and surgery- and symptoms-free survival rates were calculated. Nonparametric tests and survival analysis were used. Results  The CGQL total scores and symptom frequency rate were found to be similar in the two groups (resection vs nonresection). Only current quality of health item was significantly worse in patients who had undergone colonic resection (p = 0.05). No difference was found in the rate and in the timing of surgical procedures and hospital admitting for DD in the two groups. In particular, the nine patients classified as Hinchey 1 who underwent surgery reported the same quality of life, symptoms frequency, operation, and hospital admitting rate as those who had been admitted with the same disease class but who received medical treatment only. Conclusions  Our results indicate that there does not seem to be any long-term advantage to colonic resection which should be considered only in patients presenting complicated DD. Presented as a poster at the Digestive Disease Week, San Diego CA, USA May 19-24, 2008.     

Thoracic Epidural versus Intravenous Patient-controlled Analgesia after Cardiac Surgery: A Randomized Controlled Trial on Length of Hospital Stay and Patient-perceived Quality of Recovery

Background: Perioperative thoracic epidural analgesia reduces stress response and pain scores and may improve outcome after cardiac surgery. This prospective, randomized trial was designed to compare the effectiveness of patient-controlled thoracic epidural analgesia with patient-controlled analgesia with intravenous morphine on postoperative hospital length of stay and patients' perception of their quality of recovery after cardiac surgery.

Methods: One hundred thirteen patients undergoing elective cardiac surgery were randomly assigned to receive either combined thoracic epidural analgesia and general anesthesia followed by patient-controlled thoracic epidural analgesia or general anesthesia followed by to patient-controlled analgesia with intravenous morphine. Postoperative length of stay, time to eligibility for hospital discharge, pain and sedation scores, degree of ambulation, lung volumes, and organ morbidities were evaluated. A validated quality of recovery score was used to measure postoperative health status.

Results: Length of stay and time to eligibility for hospital discharge were similar between the groups. Study groups differed neither in postoperative global quality of recovery score nor in five dimensions of quality of recovery score. Time to extubation was shorter (P < 0.001) and consumption of anesthetics was lower in the patient-controlled thoracic epidural analgesia group. Pain relief, degree of sedation, ambulation, and lung volumes were similar between the study groups. There was a trend for lower incidences of pneumonia (P = 0.085) and confusion (P = 0.10) in the patient-controlled thoracic epidural analgesia group, whereas cardiac, renal, and neurologic outcomes were similar between the groups.     

Effect of Patient-controlled Perineural Analgesia on Rehabilitation and Pain after Ambulatory Orthopedic Surgery: A Multicenter Randomized Trial

Background: Efficacy of continuous perineural and patient-controlled ropivacaine infusion at home after orthopedic surgery was compared with patient-controlled intravenous morphine for functional recovery and postoperative analgesia in a multicenter randomized trial.

Methods: Eighty-three patients scheduled to undergo acromioplasty or hallux valgus surgery received an interscalene (n = 40) or popliteal (n = 43) peripheral nerve block with 30 ml ropivacaine, 0.5%. After randomization, patients were discharged home 24 h after surgery with a disposable infusion pump delivering either patient-controlled intravenous morphine (n = 23) or perineural 0.2% ropivacaine infusion, either continuous infusion without bolus (n = 30) or basal infusion plus bolus (n = 30). The patients recorded pain scores on movement and/or walking and were directed to take paracetamol and rescue analgesics if necessary. The time necessary to be able to walk for 10 min; daily activities on days 1, 2, and 3; adverse events; and overall satisfaction scores were noted and graded by the patient.

Results: Basal-bolus ropivacaine decreased the time to 10 minutes' walk, optimized daily activities (P < 0.01), and decreased the amount of ropivacaine used. The morphine group had greater pain scores and consumption of morphine and ketoprofen compared with both ropivacaine groups (P < 0.05). The incidence of nausea/vomiting, sleep disturbance, and dizziness increased, and the patient satisfaction score decreased in the morphine group (P < 0.05).     

Epidural Infusion of Ropivacaine for Postoperative Analgesia after Major Orthopedic Surgery: Pharmacokinetic Evaluation

Background: Changing plasma protein concentrations may affect the protein binding and pharmacokinetics of drugs in the postoperative phase. Therefore, the authors evaluated the pharmacokinetics of ropivacaine, administered by 72-h epidural infusion to provide postoperative analgesia.

Methods: Twenty-eight patients, scheduled for major orthopedic surgery during combined epidural and general anesthesia received a bolus dose of ropivacaine (50 or 75 mg), followed by constant-rate (10 ml/h) epidural infusion of ropivacaine 2 mg/ml (group 1) or 3 mg/ml (group 2). Total and unbound plasma concentrations of ropivacaine and pipecoloxylidide and plasma concentrations of [alpha]1-acid glycoprotein were determined. In addition, the urinary excretion of ropivacaine and major metabolites was measured.

Results: Total plasma concentrations of ropivacaine increased steadily during the infusion, reaching 2.7 +/- 0.7 and 2.9 +/- 0.5 mg/l in groups 1 and 2 after 72 h constant-rate infusion. Unbound ropivacaine concentrations reached average steady state levels of approximately 0.06 and 0.07 mg/l. Total and unbound concentrations of pipecoloxylidide increased to 1.0 +/- 0.4 and 0.4 +/- 0.2 mg/l (group 1) and 1.2 +/- 0.4 and 0.5 +/- 0.1 mg/l (group 2) after 72 h infusion. [alpha]1-Acid glycoprotein concentrations initially decreased, but thereafter increased steadily to approximately twice the baseline values.     

Postoperative Wound Oxygen Tension with Epidural or Intravenous Analgesia: A Prospective, Randomized, Single-blind Clinical Trial

Background: Adequate tissue oxygen tension is an essential requirement for surgical-wound healing. The authors tested the hypothesis that epidural anesthesia and analgesia increases wound tissue oxygen tension compared with intravenous morphine analgesia.

Methods: In a prospective, randomized, blind clinical study, the authors allocated patients having major abdominal surgery (n = 32) to receive combined general and epidural anesthesia with postoperative patient-controlled epidural analgesia (epidural group, n = 16), or general anesthesia alone with postoperative patient-controlled intravenous analgesia (intravenous group, n = 16). An oxygen sensor and a temperature sensor were placed subcutaneously in the wound before closure. Wound oxygen tension (Pwo2) and temperature were measured continuously for 24 h. Other variables affecting wound tissue oxygenation and visual analogue scale (VAS) pain scores were also documented.

Results: Despite epidural patients having lower body temperatures at the end of surgery (35.7 +/- 0.3) versus 36.3 +/- 0.5 [degrees]C, P = 0.004), they had significantly higher mean Pwo2 over the 24 h period, compared with the intravenous group (64.4 +/- 14 vs. 50.7 +/- 15) mmHg, mean (SD), 95% CI difference, -22 to -5, P = 0.002). Area under the Pwo2 -24 h time curve was also significantly higher in the epidural group (930 +/- 278 vs. 749 +/- 257) mmHg x h, 95% CI difference -344 to -18, P = 0.03). VAS pain scores at rest and moving were significantly lower in the epidural group at all times.     

Systemic Lidocaine to Improve Quality of Recovery after Laparoscopic Bariatric Surgery: A Randomized Double-Blinded Placebo-Controlled Trial

Background

Few multimodal strategies to minimize postoperative pain and improve recovery have been examined in morbidly obese patients undergoing laparoscopic bariatric surgery. The main objective of this study was to evaluate the effect of systemic intraoperative lidocaine on postoperative quality of recovery when compared to saline.

Methods

The study was a prospective randomized, double-blinded placebo-controlled clinical trial. Subjects undergoing laparoscopic bariatric surgery were randomized to receive lidocaine (1.5 mg/kg bolus followed by a 2 mg/kg/h infusion until the end of the surgical procedure) or the same volume of saline. The primary outcome was the quality of recovery 40 questionnaire at 24 h after surgery.

Results

Fifty-one subjects were recruited and 50 completed the study. The global QoR-40 scores at 24 h were greater in the lidocaine group median (IQR) of 165 (151 to 170) compared to the saline group, median (IQR) of 146 (130 to 169), P?=?0.01. Total 24 h opioid consumption was lower in the lidocaine group, median (IQR) of 26 (19 to 46)?mg IV morphine equivalents compared to the saline group, median (IQR) of 36 (24 to 65)?mg IV morphine equivalents, P?=?0.03. Linear regression demonstrated an inverse relationship between the total 24 h opioid consumption (IV morphine equivalents) and 24 h postoperative quality of recovery (P?<?0.0001).

Conclusions

Systemic lidocaine improves postoperative quality of recovery in patients undergoing laparoscopic bariatric surgery. Patients who received lidocaine had a lower opioid consumption which translated to a better quality of recovery.     

全膝关节置换术后股神经阻滞自控镇痛的随机对照研究

目的比较患者自控与恒速输注2种给药方案对全膝关节置换术后患者股神经阻滞镇痛的效果。方法 2010年3月～11月选择60例单侧全膝关节置换术,椎管内麻醉前在超声及神经刺激器引导下置入连续股神经阻滞导管,将阻滞效果完全的患者按随机数字表随机分为2组：恒速输注组（CI组）和患者自控镇痛组（PCA组）。CI组经导管持续输注0.2%罗哌卡因5 ml/h,PCA组输注0.2%罗哌卡因背景量5 ml/h,单次注射5 ml/次,锁定时间60 min。记录2组患者静息痛及运动状态下疼痛评分、满意率以及不良反应发生情况。结果 3例在首次给药后30 min内没有达到完全阻滞而被排除。术后1～3 d静息及主动锻炼时疼痛评分2组无显著性差异（P〉0.05）。术后1～3 d被动锻炼时疼痛评分PCA组（4.7±1.3,4.5±1.0,4.5±1.0）显著低于CI组（6.5±1.6,6.1±1.6,5.9±1.6）（P〈0.05）。患者满意度PCA组显著高于CI组[8（6～10）vs.7（4～9）]（Z=16.957,P=0.031）。2组患者均无耳鸣、口周麻木、眩晕等局麻药中毒症状同,均无因下肢无力而跌倒,无导管脱出。结论与恒速输注相比,患者自控股神经阻滞能够提高术后康复运动时的镇痛效果。