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   Table of Contents - Current issue
Coverpage
October-December 2018
Volume 3 | Issue 4
Page Nos. 81-126

Online since Thursday, January 24, 2019

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RESEARCH ARTICLES  

Ultrasound-guided supine lumbar plexus block versus iliac fascia block for analgesia in older adult patients undergoing hip replacement: a randomized controlled trial p. 81
Xiao-Long Lu, Xue-Feng Yu, Si-Mao Hu, Xue-Lei Zheng, Qiong Li, Yong Liu, Pan-Ru Wang, Jian-Min Peng, Bin Mei
DOI:10.4103/2542-4157.248573  
Background and objectives: Anesthesia is an important part of hip replacement in older adult patients. Lumbar plexus block and iliac fascia block are common block methods in hip replacement. This study will compare the analgesic effects of ultrasound-guided supine lumbar plexus block and multi-angle multi-point iliac fascia block during hip replacement in older adult patients. The result will identify the optimal analgesic regimen. Methods: This prospective, single-center (Lu’an Civily Hospital in China), randomized controlled trial will include 208 older adult patients who are scheduled to undergo hip replacement. The patients will be randomly assigned to one of two groups (n = 104/group). In the lumbar plexus-block group, patients will undergo supine lumbar plexus block, general anesthesia using a laryngeal mask airway, and subsequent hip replacement. In the iliac fascia-block group, patients will undergo multi-angle multi-point iliac fascia block, general anesthesia using a laryngeal mask airway, and subsequent hip replacement. After surgery, all patients will be followed up for 24 hours. Results: The primary outcome measure of this study is a Visual Analog Scale score obtained 24 hours post-surgery, which will be used to evaluate the postoperative analgesic effect. The secondary outcome measures are Visual Analog Scale scores at 2, 6 and 12 hours post-surgery, heart rate at various time points during the surgery (laryngeal mask placement, T0; surgical incision, T1; surgical reaming, T2; prosthesis implantation, T3; incision suture, T4; and resuscitation, T5), mean arterial pressure, blood oxygen saturation, intraoperative sufentanil, perdipine, and ephedrine dosages, total amount of intravenous patient-controlled analgesics at 2, 6, 12, and 24 hours post-surgery, and incidence of adverse reactions. Results of a pilot study involving 60 older adult patients who underwent hip replacement during March 2018 through September 2018 showed that intraoperative sufentanil, perdipine, and ephedrine dosages were significantly lower in the lumbar plexus-block group (n = 30) than in the iliac fascia-block group (n = 30; P < 0.05); heart rate at T2, T3, T4 and T5 was significantly lower in the lumbar plexus-block group than in the iliac fascia block group (P < 0.05); heart rate at T1, T2, T3, and T5 was significantly greater than that at T0 in the iliac fascia-block group (P < 0.05); mean arterial pressure at T1, T2, T3, T4 and T5 was significantly lower in the lumbar plexus-block group than that in the iliac fascia-block group (P < 0.05), and mean arterial pressure at T1, T2, T3, and T4 was significantly higher than that at T0 in the iliac fascia-block group (P < 0.05). Mean arterial pressure at T3 and T4 was significantly lower than that at T0 in the lumbar plexus-block group (P < 0.05). Visual Analog Scale scores at 6, 12, and 24 hours post-surgery were significantly higher in the iliac fascia-block group than in the lumbar plexus-block group (P < 0.05). Conclusion: Results from this study will provide evidence indicating whether ultrasound-guided supine lumbar plexus block in combination with general anesthesia can more effectively maintain stable hemodynamic indices during hip replacement and whether it results in more encouraging postoperative analgesic effects in older adult patients than multi-angle multi-point iliac fascia block. Ethics and trial registration: This study was approved by the Medical Ethics Committee of Lu’an Civily Hospital in March 2018 (approval No. PJ2018-001). The study protocol version is 1.0. Patients participating in this study will provide their written informed consent after fully understanding the study protocol. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800019888).
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Efficacy of arthroscopic surgery for discoid lateral meniscus injury in knee joint: a self-control study p. 89
Jian-Jun Mai, Bin Xu, Jun Tu, Lei Wu
DOI:10.4103/2542-4157.248605  
Background and objectives: Discoid meniscus injury is a rare form of abnormal meniscus morphology with unknown pathogenesis. The complete disc-shaped meniscus is more prone than incomplete disc-shaped meniscus to tearing and adverse reactions such as joint degeneration and osteochondritis. Moreover, its clinical efficacy is not satisfactory. Arthroscopic meniscus surgery can enhance the stability of the meniscus and provide sufficient cushioning pressure to prevent recurrent meniscal tears. Therefore, this study will investigate the efficacy of arthroscopic surgery for discoid meniscus injury in knee joint and analyze risk factors that influence the efficacy of arthroscopic surgery. Methods: This single-center, self-control study will include 196 patients with discoid meniscus injury who will receive arthroscopic meniscus repair (Stryker) from December 2018 to December 2019 at the Department of Sports Trauma and Arthroscopy, First Affiliated Hospital of Anhui Medical University of China. This surgical procedure will include meniscus plasty and subtotal meniscectomy. After surgery, all included patients will be followed up for 6–18 months. Surgical efficacy will be evaluated by Lysholm score. Patients will be divided into an excellent-and-good group (Lysholm score ≥ 85) and a poor group (Lysholm score < 85). Results: The primary outcome measure of this study is the change in excellent-and-good rate of Lysholm score that reflects knee joint function measured at the last follow-up in patients undergoing arthroscopic meniscus surgery. Secondary outcome measures are Lysholm score; Outerbridge grade of chondral lesion; knee joint morphology by magnetic resonance images before surgery and at the last follow-up; age, sex, lesion region, and course of disease before surgery; and incidence of adverse reactions at the last follow-up. Clinical data from 115 patients with discoid meniscus injury (150 knees) who received treatment from April 2015 to September 2016 were retrospectively analyzed. Six to eighteen months of follow-up of 115 patients revealed a significant difference in Lysholm scores before surgery (65.80 ± 9.39) and at the last follow-up (89.15 ± 7.45; P < 0.05). Postoperative Lysholm scores were excellent in 32 patients, good in 61 patients, fair in 18 patients, and poor in four patients, with an excellent-and-good rate of 80.9%. Knee joint infection did not occur in any patient. There were four patients with lateral interstitial pain and two patients with lateral instability of the knee joint. Logistic regression analysis revealed that course of disease, age, and Outerbridge grade of chondral lesion were risk factors that influenced the efficacy of arthroscopic meniscus surgery. Conclusion: Results from this study hope to confirm that arthroscopic surgery for discoid meniscus injury is a definitive treatment technique. Patient age and the degree of chondral lesion are closely related with efficacy, so it is recommended that patients with symptomatic discoid meniscus injury undergo surgery as soon as possible. Ethics and trial registration: This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Anhui Medical University (approval No. PJ2018-02-03) on February 5, 2018. The version of the study protocol is 1.0. Patients and their family members will volunteer to participate in this study. Written informed consent will be obtained from each patient. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800019182) on October 30, 2018.
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Local anesthetic infiltration before open reduction and internal fixation for ankle fracture: a single-blind randomized controlled study p. 97
Juan Lopez-Valencia, Juan Jonathan De la Cruz-Pacheco, Joel Galindo-Avalos, Juan Manuel Gómez-Gómez, Alexis Rubén Álvarez-Narvaéz, Avelino Colín-Vázquez, Anapaola Koch-Leopo
DOI:10.4103/2542-4157.248606  
Background and objectives: Ankle fractures are painful. Intense uncontrolled postoperative pain may lead to persistent pain and complications. Local anesthetic infiltration into a surgical wound or joint blocks the pain at its origin, and thus it is particularly well-suited for ambulatory surgery. Several studies have shown a clear correlation between increased local and regional anesthesia use and the success of major knee and shoulder procedures in an ambulatory setting. The preferred indication for local infiltration is foot and ankle surgery, as it allows for earlier ambulation and reduces the risk of falls when compared to more extensive blocks of the lower limp. The purpose of this study was to investigate the preoperative use effects of local infiltration of ropivacaine or bupivacaine in pain management after open reduction and internal fixation treatment for ankle fracture. Methods: In this prospective single-blind randomized controlled trial, 93 patients (42 women and 51 men) were randomly divided into ropivacaine (spinal anesthesia + local anesthetic infiltration with 37.5 mg of 0.75% ropivacaine), bupivacaine (spinal anesthesia + local anesthetic infiltration with 25 mg of 0.5% bupivacaine) and control (spinal anesthesia only) groups. All patients underwent open reduction and internal fixation for acute ankle fracture and local anesthetic infiltration was applied before incision. Pain was evaluated using Visual Analog Scale scores at 4, 8, 12, and 24 hours after surgery. Results: Local anesthesia with ropivacaine was better in pain management with a lower Visual Analog Scale score at 4 hours after surgery than local anesthesia with bupivacaine and spinal anesthesia (P < 0.05). At 8, 12 and 24 hours, local anesthesia with ropivacaine was slightly, but not significantly, better than local anesthesia with bupivacaine and spinal anesthesia (P > 0.05). Conclusions: Ropivacaine tends to have a rapider onset of action, longer acting effect, fewer complications, and lower motor block than bupivacaine in preoperative local anesthesia. Ethics and trial registration: This study protocol has been approved by the local ethics committee of IMSS in México (approval No. R-2016-3401-55) and was registered with ClnicalTrials.gov (Identifier: NCT02949674) on October 31, 2016.
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Clinicopathological characterization of long bone non-union: a prospective cross-sectional study p. 101
Avelino Colin-Vazquez, Luis Dario Bernal-Fortich, Joel Galindo-Avalos, Juan López-Valencia, Rafael Grajales-Ruiz, Adrián Miguel-Pérez, Jorge Quiroz-Williams, Elizabeth Pérez-Hernández
DOI:10.4103/2542-4157.248607  
Background and objectives: The exact biological process that leads to a non-union remains obscure and it is well accepted that any intervention to reverse this process must be timely and well directed to re-establish both biological and mechanical deficiencies. The purpose of the present work was to identify the possible morphological patterns of bone tissue in a state of non-union and in the presence or absence of infection. Methods: A prospective, observational, cross-sectional study was performed. Bone tissue samples obtained from patients with radiologically and clinically diagnosed long bone non-union undergoing revision surgery were included, without distinction of age and sex. Histopathological analysis and semiquantitative evaluation of tissue samples were performed using conventional optical microscopy. Clinical data related to the study variables were obtained, such as type of consolidation, time of evolution, and corresponding bacteriological analysis. Results: Several morphological pattern variables such as bone quality, osteosclerosis, areas of bone devitalization, osteoclastic activity, vascularization, and in particular cell density were related to the subtype of long bone non-union. They were also associated with septic and aseptic variants of long bone non-union. Conclusion: The biological bone profiles, in particular the histomorphological characteristics, are related to the subtype of non-union and reflect the physiopathological environment that involves an anabolic and catabolic imbalance. These can be incorporated into the classification system and favor the stratification of non-union. Ethics and trial registration: This study was approved by Comité Local de Investigación y Ética en Investigación en Salud at UMAE “Dr. Victorio de la Fuente Narváez” (R-2017-3401-8) on July 19, 2017 and registered with SIRELCIS (identifier: R-2017-3401-8).
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STUDY PROTOCOL Top

Efficiency of tight monitoring by nurse practitioners in rheumatoid arthritis patients in remission after treatment with rituximab: study protocol for a randomized, open-label, controlled trial p. 107
Deborah Lebedieff, Hélène Boulard, Béatrice Godon, Marine Grandjean, Christian Marcelli, Olivier Vittecoq
DOI:10.4103/2542-4157.248608  
Background and objectives: Rituximab (RTX) is one of the biologics available for rheumatologists to treat patients with rheumatoid arthritis (RA). While the reprocessing procedures for other biologic agents are clearly established, this is not the case for RTX. RTX is currently re-administered when clinical relapse occurs (6 to 18 months after initiation of treatment, beyond 24 months for some patients). However, this reprocessing method is not satisfactory because the resumption of symptomatology is generally detected too late. For patients, this delay can lead to increased doses of background and symptomatic treatments, an altered quality of life due to increased pain intensity, joint swelling, nocturnal awakening and morning stiffness and an aggravation of joint destruction. We hypothesize that tight monitoring by a nurse practitioner of RA patients in remission after treatment with RTX is more effective to detect very early relapse of the disease than follow-up exclusively managed by the attending rheumatologist. Design: A prospective, controlled, randomized, open-label, bicentric clinical trial. Methods: Eighty-eight patients with RA in remission receiving RTX treatment are randomly assigned to an observation group or a control group at a 1:1 ratio. In the control group, patients are followed only by the attending rheumatologist every 3 to 4 months according to common practices. In the observation group, patients are subjected to tight monitoring every month by a nurse practitioner in addition to follow-up by the attending rheumatologist. When increased disease activity is observed (disease activity score based on 28 joints (DAS28)-C-reactive protein (CRP) > 2.7), a new cycle of RTX is prescribed by an independent hospital practitioner. Outcome measures: The primary outcome measure is the value of DAS28-CRP at the time of a new cycle of RTX. The secondary outcome measures are the cumulative dose of glucocorticosteroids and/or non-steroidal anti-inflammatory drugs between two cycles of RTX and quality of life questionnaires. Discussion: This study corresponds to the combined management of RA by a nurse practitioner and an attending rheumatologist. A monthly telephone interview conducted by the nurse practitioner enables discussion on all aspects of the disease and regular follow-up to allow frequent readjustments. Thus, patients with good response to RTX treatment at 6 months might benefit from nursing follow-up alone to detect relapse. Such a practice is easily reproducible for RA patients in clinical remission after other treatments. Ethics and dissemination: This trial was approved by the Northwestern France Ethics Committee (approval number: CPP-SC 02/2016) on June 1, 2016. The study protocol is conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent is obtained from all participants. Subject recruitment is underway. Data collection began in May 2017 and will end in May 2021. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: ClinicalTrials.gov identifier: NCT03027999 on January 23, 2017.
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Hemostasis following local versus intravenous tranexamic acid in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures: study protocol for a parallel-group, randomized controlled trial p. 113
Jun Sheng, Da Liu, Ying Chen, Xi-Lin Liu, Hong-Hua Wu, Wei Zheng
DOI:10.4103/2542-4157.248609  
Background and objectives: Local bleeding is relatively frequent during and after posterior open reduction and internal fixation of thoracolumbar fractures, with associated health risks. Both local and intravenous tranexamic acid have been shown to effectively reduce intraoperative blood loss, but the optimal method for achieving intraoperative hemostasis remains unclear. This study aims to compare hemostasis following local and intravenous tranexamic acid administration in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures. Design: A prospective, single-center, parallel-group, randomized controlled trial. Methods: This trial is conducted in 150 patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures at the Department of Orthopedics, the General Hospital of Western Theater Command, China. The included patients are divided randomly and evenly into three groups (n = 50 per group). Patients in the intravenous administration group receive 100 mg/kg tranexamic acid dissolved in 100 mL normal saline intravenously 15 minutes before surgery; in the local administration group, the wound is flushed with a mixture of 10 mg/kg tranexamic acid and 50 mL normal saline before wound closure. Excess fluid is removed 10 minutes later using an aspirator and the wound is closed. Patients in the control group receive intravenous and local administration of normal saline. All patients are followed up at 1, 3, and 5 days after surgery. Outcome measures: The primary outcome measure is intraoperative blood loss, as a measure of intraoperative hemostasis. The secondary outcome measures are intraoperative blood transfusion, amount of drainage at postoperative days 1, 3, and 5, hemoglobin level, D-dimer level, international normalized ratio, prothrombin time, and activated partial thromboplastin time before surgery and at postoperative days 1, 3, and 5. Disscusion: This study compares hemostasis following local versus intravenous tranexamic acid administration in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures, to determine the optimal intraoperative hemostasis program for reducing surgical risk. Ethics and dissemination: This study has been approved by the Medical Ethics Committee of the General Hospital of Western Theater Command, China (approval No. 2015-keyan-03). The version of study protocol is 1.3. Patients and their family members should participate in this study voluntarily and written informed consent should be obtained from each patient. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This study protocol was registered with Chinese Clinical Trial Registry (registration number: ChiCTR-ICR-15006037) on January 26, 2015.
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Efficacy of silver needle acupuncture combined with muscle relaxation in the treatment of capulohumeral periarthritis: study protocol for a prospective, single-center, randomized, parallel-controlled trial p. 120
Jun-Min Yu, Jun-Jie Yu, Hui-Hui Cai, Chuan-Sheng Liu, Yan-Wei Yin, Feng-He Xu, Yu-Sheng Yi, Chao Meng
DOI:10.4103/2542-4157.248610  
Background and objectives: Muscle relaxation therapy comprising general anesthesia and an intra-articular injection of betamethasone is commonly used to treat capulohumeral periarthritis. This treatment quickly improves the limited motion of the shoulder joint and restores the shoulder to its functional position, but cannot effectively inhibit the inflammatory response. Aseptic inflammatory pain can reportedly be relieved by silver needle acupuncture. However, there is insufficient high-quality evidence to validate the efficacy of silver needle acupuncture in the treatment of capulohumeral periarthritis. Therefore, the proposed study aims to evaluate the efficacy of silver needle acupuncture combined with muscle relaxation therapy in the treatment of capulohumeral periarthritis. Design: A prospective, single-center, open-label, randomized, parallel-controlled trial. Methods: Sixty patients with capulohumeral periarthritis will be assigned to receive either silver needle acupuncture plus muscle relaxation therapy (n = 30) or muscle relaxation therapy alone (n = 30). Patients will be followed up at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment. Outcome measures: The primary outcome measure is a Visual Analog Scale score obtained at 3 days post-treatment. The secondary outcome measures are: the Visual Analog Scale scores before treatment and at 14 days, and 1, 3, 6, and 12 months post-treatment; the Shoulder Joint Activity Function Rating Scale (Melle scale) score, American Shoulder and Elbow Surgeons Standardized Shoulder score, McGill Pain Questionnaire score, University of California at Los Angeles shoulder score before treatment and at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment; 12-item Short-Form Health Survey score at 1, 3, 6, and 12 months post-treatment; and the incidence of adverse events at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment. Conclusion: The study results will provide evidence indicating whether silver needle acupuncture plus muscle relaxation is more effective than muscle relaxation alone in the treatment of capulohumeral periarthritis. We hypothesize that silver needle acupuncture plus muscle relaxation not only improves shoulder joint function, but also reduces inflammatory pain in the shoulder joint. Ethics and dissemination: This study was approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University of China on June 25, 2018 (approval No. QDDXFSYY-LL-06-25). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent regarding the study protocol and surgery procedure will be obtained from each participant. This study was designed in June 2018. Patient recruitment and data collection began in September 2018 and patient recruitment will end in April 2019. Result analysis will be performed in May 2020. This study will be scheduled to end in June 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016706). Study protocol version: 1.0.
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