scholarly journals The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Maxime Léger ◽  
Solène Pessiot-Royer ◽  
Tristan Perrault ◽  
Elsa Parot-Schinkel ◽  
Fabienne Costerousse ◽  
...  

Abstract Background Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries. Methods The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview. Discussion This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life. Trial registration ClinicalTrials.gov NCT04797312. Registered on 15 March 2021

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Grelz Henrik ◽  
Midlöv Patrik ◽  
Håkansson Anders ◽  
Jakobsson Ulf ◽  
Rivano Fischer Marcelo ◽  
...  

Abstract Background Opioids are still widely prescribed to long-term pain patients although they are no longer recommended for long-term treatments due to poor evidence for long-term efficacy, risks of serious side effects, and the possibility of inducing opioid hyperalgesia. In a Cochrane study from 2017, the authors identified an urgent need for more randomized controlled trials investigating the efficiency and effects of opioid tapering. The study aimed to assess (1) the efficiency of a structured intervention in causing stable reductions of opioid consumption in a population with long-term non-malignant pain and (2) effects on pain, pain cognitions, physical and mental health, quality of life, and functioning in response to opioid tapering. Methods The study is a randomized controlled trial. The sample size was set to a total of 140 individuals after estimation of power and dropout. Participants will be recruited from a population with long-term non-malignant pain who will be randomly allocated to (1) the start of tapering immediately or (2) the control group who return to usual care and will commence tapering of opioids 4 months later. A 12-month follow-up is included. When all follow-ups are closed, data from the Swedish drug register of the National Board of Health and Welfare will be collected and individual mean daily opioid dose in morphine equivalents will be calculated at three time points: baseline, 4 months, and 12 months after the start of the intervention. At the same time points, participants fill out the following questionnaires: Numeric Pain Rating Scale (NPRS), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Chronic Pain Acceptance Questionnaire (CPAQ-8), Hospital Anxiety and Depression Scale (HADS), and RAND-36. At baseline and follow-up, a clinical assessment of opioid use disorder is performed. Discussion A better understanding of the efficiency and effects of opioid tapering could possibly facilitate attempts to taper opioid treatments, which might prove beneficial for both the individual and society. Trial registration ClinicalTrials.gov NCT03485430. Retrospectively registered on 26 March 2018, first release date. “Tapering of Long-term Opioid Therapy in Chronic Pain Population. RCT with 12 Months Follow up (TOPIO).” First patient in trial 22 March 2018.


2021 ◽  
Author(s):  
Johan A Malmgren ◽  
Ann-Charlotte Waldenström ◽  
Christian Rylander ◽  
Elias Johannesson ◽  
Stefan Lundin

Abstract BackgroundICU survivorship includes a diverse burden of disease. Current questionnaires used for collecting information about health-related problems and their relation to quality of life lack detailed questions in several areas relevant to ICU survivors. Our aim was to construct a provisional questionnaire on health-related issues based on interviews with ICU survivors and to test if this questionnaire was able to show differences between ICU survivors and a control group.MethodsThirty-two ICU survivors were identified at a post-ICU clinic and interviewed at least six months after ICU discharge. Using an established qualitative methodology from oncology, all dysfunctions and disabilities were extracted, rephrased as questions and compiled into a provisional questionnaire. In a second part, this questionnaire was tested on ICU survivors and controls. Inclusion criteria for the ICU survivors were ICU stay at least 72 hours with ICU discharge six months to three years prior to the study. A non-ICU treated control group was obtained from the Swedish Population Register, matched for age and sex. Eligible participants received an invitation letter and were contacted by phone. If willing to participate, they were sent the questionnaire. Descriptive statistics were applied.ResultsAnalysis of the interviews yielded 238 questions in 13 domains: cognition, fatigue, physical health, pain, psychological health, activities of daily life, sleep, appetite and alcohol, sexual health, sensory functions, gastrointestinal functions, urinary functions and work life.In the second part, 395 of 518 ICU survivors and 197 of 231 controls returned a completed questionnaire, the response rates being 76.2% and 85.3% respectively. The two groups differed significantly in 13 of 22 comorbidities. ICU survivors differed in a majority of questions (p ≤ 0.05) distributed over all 13 domains compared with controls.ConclusionsThis study describes the development of a provisional questionnaire to identify health-related quality of life issues and long-term burden of disease after intensive care.The questionnaire was answered by 395 ICU survivors. The questionnaire could identify that they experience severe difficulties in a wide range of domains compared with a control group.Trial registrationClinicalTrials.gov Ref# NCT 02767180


2019 ◽  
Author(s):  
Francisco Jesús Represas Carrera Sr ◽  
Ángel Alfredo Martínez Ques Sr ◽  
Ana Clavería Fontán Sr

BACKGROUND Diabetes mellitus is currently a major public health problem worldwide. It is traditionally approached in a clinical inpatient relationship between the patient and the healthcare professional. However, the rise of new technologies, particularly mobile applications, is revolutionizing the traditional healthcare model through the introduction of telehealthcare. OBJECTIVE (1) To assess the effects of mobile applications for improving healthy lifestyles on the quality of life and metabolic control of diabetes mellitus in adult patients. (2) To describe the characteristics of the mobile applications used, identify the healthy lifestyles they target, and describe any adverse effects their use may have. METHODS Review of systematic reviews and meta-analysis, following the guidelines of the Cochrane Collaboration and the Joanna Briggs Institute. We included studies that used any mobile application aimed at helping patients improve self-management of diabetes mellitus by focusing on healthy lifestyles. Studies needed to include a control group receiving regular care without the use of mobile devices. In May 2018, a search was conducted in Medline, Embase, Cochrane, LILACS, PsychINFO, Cinahl and Science Direct, updated in May 2019. The methodological quality of the studies was assessed using the Amstar-2 tool. RESULTS Seven systematic reviews of 798 articles were initially selected for analysis. The interventions had a duration of between 1 and 12 months. Mobile applications focused singly or simultaneously on different lifestyles aspects (diet, physical exercise, motivation, blood glucose levels, etc.). There are significant changes in HbA1c values, body weight and BMI, although in others, such as lipid profile, quality of life, or blood pressure, there is no clear improvement. CONCLUSIONS There is clear evidence that the use of mobile applications improves glycemic control in diabetic patients in the short term. There is a lack of evidence in its long-term benefits. It is thus necessary to carry out further studies to learn about the long-term effectiveness of mobile applications aimed at promoting the healthy lifestyles of diabetic patients. CLINICALTRIAL PROSPERO Register: CRD42019133685


Medicina ◽  
2021 ◽  
Vol 57 (2) ◽  
pp. 122
Author(s):  
Marta Pérez-Rodríguez ◽  
Saleky García-Gómez ◽  
Javier Coterón ◽  
Juan José García-Hernández ◽  
Javier Pérez-Tejero

Background and objectives: Acquired brain injury (ABI) is the first cause of disability and physical activity (PA) is a key element in functional recovery and health-related quality of life (HRQoL) during the subacute and chronic phases. However, it is necessary to develop PA programs that respond to the heterogeneity and needs of this population. The aim of this study was to assess the effectiveness of a PA program on the HRQoL in this population. Materials and Methods: With regard to recruitment, after baseline evaluations, participants were assigned to either the intervention group (IG, n = 38) or the control group (CG, n = 35). Functional capacity, mood, quality of life and depression were measured pre- and post-intervention. The IG underwent the “Physical Activity and Sport for Acquired Brain Injury” (PASABI) program, which was designed to improve HRQoL (1-h sessions, two to four sessions/week for 18 weeks). The CG underwent a standard rehabilitation program without PA. Results: Results for the IG indicated significant differences and large effect sizes for the physical and mental dimensions of quality of life, as well as mood and functional capacity, indicating an increase in HRQoL. No significant differences were found for the CG across any variables. Conclusions: The PASABI program was feasible and beneficial for improving physiological and functionality variables in the IG. The wide range of the activities of the PASABI program allow its application to a large number of people with ABI, promoting health through PA, especially in the chronic phase.


Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 54
Author(s):  
Mario Luciano ◽  
Luca Steardo ◽  
Gaia Sampogna ◽  
Vito Caivano ◽  
Carmen Ciampi ◽  
...  

Background and objectives: Bipolar disorder (BD) is one of the most burdensome psychiatric illnesses, being associated with a negative long-term outcome and the highest suicide rate. Although affective temperaments can impact on BD long-term outcome, their role remains poorly investigated. The aims of the present study are to describe the clinical characteristics of patients with BD more frequently associated with the different affective temperaments and to assess the relation between affective temperaments and severity of clinical picture in a sample of patients with BD. Materials and Methods: A total of 199 patients have been recruited in the outpatients units of two university sites. Patients’ psychiatric symptoms, affective temperaments, and quality of life were investigated through validated assessment instruments. Results: Predominant cyclothymic and irritable temperaments are associated to higher number of relapses, poorer quality of life, higher rates of aggressive behaviors, and suicide attempts. Conversely, the predominant hyperthymic disposition was a protective factor for several outcome measures, including relapse rate, severity of anxiety, depressive and manic symptoms, suicidality, and earlier age at onset. One limitationo of the present study is that the recruitment took place in two university sites; therefore, our findings cannot be fully generalized to the whole community of BD patients. Other limitations are the lack of a control group and the cross-sectional design of the study. Conclusions: The early identification of affective temperaments can help clinicians to identify those BD patients who are more likely to show a poor long-term outcome. An early screening of affective temperaments can be useful to develop targeted integrated pharmacological and psychosocial interventions.


2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.


Author(s):  
Somayeh Ghadimi ◽  
Atefeh Fakharian ◽  
Mohsen Abedi ◽  
Reyhaneh Zahiri ◽  
Mahsan Norouz Afjeh ◽  
...  

Background: Chronic Obstructive Pulmonary Disease (COPD) leads to limited activity and reduced quality of life. Treatment of this disease is a long-term process that requires the cooperation of patients in monitoring and treatment. Methods: In the present study which was conducted from April 2019 to March 2021 in Masih Daneshvari Hospital, Tehran, Iran, 75 patients were randomly divided into telerehabilitation and control groups. Patients in the control group received pulmonary rehabilitation including respiratory, isometric, and aerobic exercises for 8 weeks, three times per week. In the second group, patients were given a lung rehabilitation booklet and asked to repeat the exercises three times a week for four weeks according to a specific schedule. In addition, patients installed Behzee care application on the mobile phone that recorded various indicators such as heart rate, SpO2, dyspnea, fatigue, and daily activities. This application reminded the patient of the program every day and at a specific time. Finally, the patients’ conditions were compared in the two groups after 8 weeks using CAT and mMRC questionnaires and 6-Minute Walk (6MW) exercise indices as well as spirometry tests. Results: In all four indicators (6MW, CAT,  and mMRC questionnaires as well as spirometry), patients showed improvement after rehabilitation (p<0.001). This improvement was significantly higher in the telemedicine group compared to the other group (p<0.01). Conclusion: The use of telerehabilitation in COPD patients is effective in improving spirometry indices, quality of life, as well as activity and sports indices.


2020 ◽  
Vol 16 (1) ◽  
pp. 53-58
Author(s):  
Shima Rouhi ◽  
Payman Dadkhah ◽  
Manijeh Firoozi ◽  
Masoud Hashemi

Background: Several psychological interventions have been implemented to manage chronic pain. In this study, in addition to the patients, his/her spouses have participated in the program. Besides, this innovative therapy integrates several practical approaches into one comprehensive protocol. Objective: This study aimed to analyze the effectiveness of couple therapy (patient/caregiver-oriented) on improving the quality of life and reducing pain among patients with chronic pain. Methods: The present study is a quasi-experimental and clinical trial with a control group with pretest and posttest. The authors conducted this study at LABAFINEJAD Hospital in Tehran on 30 patients with chronic pain and their spouses by having a short form of a questionnaire for quality of life and chronic pain score questionnaire to measure the effectiveness of the treatment. Results: The results indicated that this treatment increased two aspects of quality of life remarkably, social function and strength for continuing the performance; that help boosts interpersonal relationships as well. Regarding the results, although the couple-based treatment could improve all aspects of pain, the two primary subscales, physical health and mental health, both enhanced. Besides, the treatment reduced the intensity of pain. Conclusion: Couple-based intervention through increasing social support, improving the quality of sex, decentralizing of pain, and paying attention to the neglected needs of caregivers and patients with chronic pain can improve quality of life and reduce pain in patients.


2007 ◽  
Vol 3;10 (5;3) ◽  
pp. 479-491 ◽  
Author(s):  
Jane C. Ballantyne

The ability of opioids to effectively and safely control acute and cancer pain has been one of several arguments used to support extending opioid treatment to patients with chronic pain, against a backdrop of considerable caution that has been based upon fears of addiction. Of course, opioids may cause addiction, but the “principle of balance” may justify that “…efforts to address abuse should not interfere with legitimate medical practice and patient care.” Yet, situations are increasingly encountered in which opioid-maintained patients are refractory to analgesia during periods of pain, or even during the course of chronic treatment. The real question is whether analgesic efficacy of opioids can be maintained over time. Overall, the evidence supporting long-term analgesic efficacy is weak. The putative mechanisms for failed opioid analgesia may be related to tolerance or opioid-induced hyperalgesia. Advances in basic sciences may help in understanding these phenomena, but the question of whether long-term opioid treatment can improve patients’ function or quality of life remains a broader issue. Opioid side effects are well known, but with chronic use, most (except constipation) subside. Still, side effects can negatively affect the outcomes and continuity of therapy. This paper addresses 1) what evidence supports the long-term utility of opioids for chronic pain; 2) how side effects may alter quality of life; 3) the nature of addiction and why it is different in pain patients, and 4) on what grounds could pain medication be denied? These questions are discussed in light of patients’ rights, and warrant balancing particular responsibilities with risks. These are framed within the Hippocratic tradition of “producing good for the patient and protecting from harm,” so as to enable 1) more informed clinical decision making, and 2) progress towards right use and utility of opioid treatment for chronic pain. Key Words: Opioids, chronic pain, addiction, side effects, utility, ethics


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