scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals The Role of Patient Education in Total Knee Arthroplasty: a new methodology for developing countries: a randomized controlled trial

2021 ◽  
Author(s):  
Marco Antonio Percope de Andrade ◽  
Guilherme Moreira Abreu e Silva ◽  
Tulio Vinicius Oliveira Campos ◽  
David Guen Kasuya Barbosa ◽  
Danilo Silva Leite ◽  
...  
Keyword(s):  
Developing Countries ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Patient Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Walk Ability ◽  
Total Knee

Abstract Background: The illiteracy index is high in public hospitals of developing countries,. We established a method in which patients are instructed before total knee arthroplasty (TKA) in a differentiated way without the necessity of reading any self-orientation. Methods: We developed a multidisciplinary approach to improve patient education in TKA comprising of a differentiated orientation conducted by an orthopedic surgeon, a nurse and a physiotherapist. It consists of standardized lectures regarding on pre, intra and post-operative issues in a randomized controlled trial of 79 consecutive patients undergoing primary TKA. Thirty-four patients received the standard education (control group) and 45 patients received the differentiated education (intervention group). The patients were evaluated during at least six months. Results: After a 6-month follow-up period, the Short Form Health Survey (SF-36), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the visual analogue pain scale (VAS) and knee range-of-motion (ROM) improved significantly in both groups. Range-of-motion was better in the intervention group (mean and SD - 106.9 ± 5.7 versus 92.5 ± 12.1 degrees, p = 0.02). Moreover, walk ability (more than 400 meters) was better in the intervention group compared with the control group (97.4% versus 72.4%, p = 0.003). In the intervention and control groups, respectively, 10.5% and 31% of patients reported the need for some walking devices (p = 0.03). Conclusions: A differentiated educational program with a multidisciplinary team had a positive impact on functional outcomes, improving ROM and walk ability of patients undergoing TKA in a short-term evaluation.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

scholarly journals Efficacy and safety of Acupuncture for Gastrointestinal Dysfunction after Laparoscopy: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
LISHA LIU ◽  
XIULI YUAN ◽  
QUANMIN JIANG ◽  
LEI YANG ◽  
GUANGQIANG HUANG ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Gastrointestinal Dysfunction ◽  
Blank Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Postoperative gastrointestinal dysfunction is one of the common complications after surgery. At present, there has no internationally recognized acupuncture program although it has a positive effect on the recovery of postoperative gastrointestinal function. In this report, we have designed a scientific trial protocol to analyze the feasibility of applying acupuncture to gastrointestinal dysfunction after laparoscopic surgery. We intend to conduct a randomized controlled trial based on this protocol to evaluate the efficacy and safety of the acupuncture for postoperative gastrointestinal dysfunction. Method / design: This study is a randomized, evaluator blinded, controlled, multi-center clinical trial, which has been designed according to the Consolidated Standards of Reporting Trials (CONSORT 2010) and the standard for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). The subjects will be chosen from the inpatients who have undergone laparoscopic surgery of Mianyang Hospital Affiliated to Chengdu University of traditional Chinese medicine, Mianyang Third People's Hospital and Mianyang Anzhou District People's Hospital. According to the random number generated by SPSS 25.0 software, the qualified subjects will be randomly assigned to the experimental group, the control group, and the blank group. Therapies will be performed 30 minutes after operation, the experimental group will be treated with acupuncture, the control group will be treated with intravenous injection of granisetron, and the blank group will be treated with intravenous injection of physiological saline. The main outcome is the first time of flatus after operation, and the secondary outcomes are abdominal pain, abdominal distention, nausea, vomiting times, gastrointestinal hormone level, and mental state. We will also evaluate the efficacy and safety of acupuncture on the basis of the principle of good clinical practice (GCP). Discuss: This is a standardized and scientific clinical trial to evaluate the efficacy and safety of acupuncture for gastrointestinal dysfunction after laparoscopic surgery. Our goal is to provide objective evidence and improve the acupoint prescription in clinical practice, so as to promote the clinical application of this technology. Trial registration China clinical trial registration ID: CHICTR -1800016991. Registered on 6 July 2018.Discussion

scholarly journals Effectiveness of a Mobile eHealth App in Guiding Patients in Pain Control and Opiate Use After Total Knee Replacement: Randomized Controlled Trial

10.2196/16415 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e16415 ◽  
Author(s):  
Yvette Pronk ◽  
Maud Cornelia Wilhelmina Maria Peters ◽  
Amarsing Sheombar ◽  
Justus-Martijn Brinkman
Keyword(s):  
Randomized Controlled Trial ◽  
Total Knee Replacement ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Opiate Use ◽  
Pain Scores ◽  
Total Knee ◽  
At Home

Background Little is known about pain and opiate use at home directly after total knee replacement (TKR). Due to adverse effects, low opiate use is desired. An electronic health app (PainCoach) was developed to guide patients in pain control and opiate use. Objective The aim of this paper was to investigate the effects of the PainCoach app on pain control and opiate use in patients who underwent TKR during the first 2 weeks at home after surgery. Methods In an unblinded randomized controlled trial, patients scheduled for TKR were offline recruited and randomized to a PainCoach group or control group. In the PainCoach group, the PainCoach app was downloaded on each patient’s smartphone or tablet. In response to the patient’s input of the pain experienced, the PainCoach app gave advice on pain medication use, exercises/rest, and when to call the clinic. This advice was the same as that received during usual care. The control group received usual care. The primary outcomes were opiate use and visual analog scale (VAS) pain scores at rest, during activity, and at night during the first 2 weeks at home after surgery, which were collected daily from day 1 until 14 postoperatively by online questionnaires. The actual amount of app use was recorded, and active use was defined as ≥12 total app uses. Results The pain scores did not differ between the groups. The PainCoach group (n=38) used 23.2% less opiates (95% CI −38.3 to −4.4; P=.02) and 14.6% more acetaminophen (95% CI 8.2-21.3; P<.001) when compared with the findings in the control group (n=33). The PainCoach app was used 12 (IQR 4.5-22.0) times per patient. In the active PainCoach subgroup (n=19), the following were noted when compared with the findings in the control group: 4.1 times faster reduction of the VAS pain score during activity (95% CI −7.5 to −0.8; P=.02), 6.3 times faster reduction of the VAS pain score at night (95% CI −10.1 to −2.6; P=.001), 44.3% less opiate use (95% CI −59.4 to −23.5; P<.001), 76.3% less gabapentin use (95% CI −86.0 to −59.8; P<.001), and 21.0% more acetaminophen use (95% CI 12.6-30.0; P<.001). Conclusions The use of the PainCoach app contributes to reduced opiate use in the initial period at home after TKR. Active use of this app leads to a further reduction in opiate use and improved pain control. Trial Registration ClinicalTrials.gov NCT03961152; https://clinicaltrials.gov/ct2/show/NCT03961152

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