scholarly journals Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

2019 ◽  
Vol 20 (4) ◽  
pp. 856 ◽  
Author(s):  
Rafal Kaminski ◽  
Marta Maksymowicz-Wleklik ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Agnieszka Dabrowska-Thing ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Tear ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Non Union ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant ◽  
Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

scholarly journals A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Rafal Kaminski ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Monika Wielgus ◽  
Maciej Langner ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Repair ◽  
International Knee Documentation Committee ◽  
Treated Group ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Parallel Group ◽  
Meniscus Healing ◽  
Ikdc Score

Objective. The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P=0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

scholarly journals Acupuncture and Postoperative Vomiting in Day-Stay Paediatric Patients

1996 ◽  
Vol 24 (6) ◽  
pp. 674-677 ◽  
Author(s):  
K. L. Schwager ◽  
D. B. Baines ◽  
R. J. Meyer
Keyword(s):  
Adult Population ◽  
Acupuncture Point ◽  
Controlled Study ◽  
Control Group ◽  
Postoperative Vomiting ◽  
Double Blind ◽  
Paediatric Patients ◽  
Transcutaneous Stimulation ◽  
Significant Difference ◽  
Stimulation Of

The stimulation of the acupuncture point P6 has been used to prevent nausea and vomiting in the adult population. It has, however, been subject to limited comparative evaluation in children. We proposed that stimulation of P6 and the analgesic point Li4 would reduce the incidence of postoperative vomiting. Eighty-four unpremedicated paediatric patients having day-stay surgery (circumcision or herniotomy/orchidopexy) were included in a randomized, double-blind, placebo-controlled study of transcutaneous stimulation of P6 and Li4 or no stimulation. The incidence of vomiting was recorded for 24 hours postoperatively. There was no statistically significant difference in total postoperative vomiting in those patients who were stimulated, compared with the control group (P=0.909), or between any group for postoperative vomiting in the recovery ward, day-stay ward or at home. For all groups, vomiting was more common within the first four hours and more likely to occur in the day-stay ward.

scholarly journals Periarticular Injection with Bupivacaine for Postoperative Pain Control in Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Varah Yuenyongviwat ◽  
Chaturong Pornrattanamaneewong ◽  
Thitima Chinachoti ◽  
Keerati Chareancholvanich
Keyword(s):  
Pain Control ◽  
Controlled Trial ◽  
Ease Of Use ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Periarticular Injection ◽  
Post Operative Pain ◽  
Significant Difference

Background. Local periarticular injection with bupivacaine alone in TKA has not been studied. Thus, we aimed to examine the effectiveness of local periarticular injection with bupivacaine for post-operative pain control in TKA.Method. Sixty patients undergoing TKA by a single surgeon were randomly assigned into two groups in a double-blind, placebo-controlled study. In the injection group, patients received periarticular injections with 0.25% bupivacaine before wound closure; in the control group, patients received a 0.9% normal saline injection. Both groups received the same anesthetic procedure, post-operative pain control, and rehabilitation protocol.Results. There was a significant reduction in post-operative morphine consumption in the first six hours after the operation (mean 0.9 mg and 2.43 mg,P=0.01), but there was no significant difference in post-operative morphine consumption between six hours and ninety-six hours after the operation, visual analogue scale (VAS) score, morphine side effects during the first 96 hours, length of hospital stay, or complications from morphine consumption.Conclusion. Local periarticular injection with bupivacaine alone before wound closer was shown to be an effective method to improve pain control after TKA with a few complications and ease of use.

scholarly journals Is Infusion of Subhypnotic Propofol as Effective as Dexamethasone in Prevention of Postoperative Nausea and Vomiting Related to Laparoscopic Cholecystectomy? A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Mine Celik ◽  
Aysenur Dostbil ◽  
Mehmet Aksoy ◽  
Ilker Ince ◽  
Ali Ahiskalioglu ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference ◽  
Group D

Background. Postoperative nausea and vomiting (PONV) is one of common complications in patients undergoing laparoscopic cholecystectomy (LC). Aim of this study was to compare the efficacy of subhypnotic (1 mg/kg/h) infusion of propofol with dexamethasone on PONV in patients undergoing LC.Methods. A total of 120 patients were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups; patients of group dexamethasone (group D) were administrated 8 mg dexamethasone before induction of anesthesia, patients of group propofol (group P) were infused to subhypnotic (1 mg/kg/h) propofol during operation and patients of group control (group C) were applied infusion of 10% intralipid. The incidence of PONV and needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively.Results. In the 0–24 h, the incidence of PONV was significantly lower in the group D and group P compared with the group C (37.5%, 40%, and 72.5%, resp.). There was no significant difference in the incidence of PONV and use of antiemetics and analgesic between group D and group P.Conclusion. We concluded that infusion of propofol 1 mg/kg/h is as effective as dexamethasone for the prevention of PONV during the first 24 hours after anesthesia in patients undergoing LC.

scholarly journals Effects of platelet-rich plasma injection on pain, range of motion, and disability in adhesive capsulitis: A prospective, randomized-controlled study

2021 ◽  
Vol 67 (4) ◽  
pp. 462-472
Author(s):  
Çağlar Karabaş ◽  
Havva Talay Çalış ◽  
Ulaş Serkan Topaloğlu ◽  
Çiğdem Karakükçü
Keyword(s):  
Range Of Motion ◽  
External Rotation ◽  
Platelet Rich Plasma ◽  
Adhesive Capsulitis ◽  
Controlled Study ◽  
Control Group ◽  
Plasma Injection ◽  
Active Flexion ◽  
Home Based ◽  
Significant Difference

Objectives: In this study, we aimed to investigate the effectiveness of intra-articular platelet-rich plasma (PRP) injection in adhesive capsulitis. Patients and methods: Between January 2019 and December 2019, a total of 40 patients (21 males, 19 females; mean age: 57.1±6.5 years; range, 44 to 72 years) with idiopathic adhesive capsulitis were included. The patients were randomly assigned into two equal groups as the PRP and the control group. The PRP group received two doses of PRP via intra-articular route biweekly under ultrasound guidance. No injection was performed to the control group. In both groups, stretching and Codman exercises were applied as a home- based program. The Visual Analog Scale (VAS), range of motion (ROM), and Shoulder Pain and Disability Index (SPADI) scores were evaluated before the treatment and at 2, 6 and 12 weeks after the treatment. Results: There were significant differences in all VAS, SPADI, and ROM scores at all time points after treatment compared to baseline in both groups. At the end of the study, there were significant differences in the active flexion, passive flexion, active abduction, passive abduction, and active external rotation scores at 12 weeks between the groups (p=0.012, p=0.015, p=0.008, p=0.019, and p=0.040, respectively). No significant difference was observed between the groups in terms of VAS and SPADI scores and the other parameters (active and passive extension, active and passive internal rotation, passive external rotation) at 2, 6, and 12 weeks (p>0.05). Conclusion: The addition of PRP to exercise treatment can improve patients' joint mobility, but not pain and disability in patients with adhesive capsulitis.

scholarly journals The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2940
Author(s):  
Marina Perić ◽  
Dominique Maiter ◽  
Etienne Cavalier ◽  
Jérôme F. Lasserre ◽  
Selena Toma
Keyword(s):  
Vitamin D ◽  
Vitamin D3 ◽  
Test Group ◽  
Controlled Study ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Pocket Depth ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Background: This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen. Methods: It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo). Results: A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (n = 13) and control groups (n = 14) had similar 25(OH) vitamin D3 levels at baseline (17.6 ± 7.4 vs. 14.4 ± 5.2, respectively). After one month, there was a significant difference between groups (32.9 ± 5.2 vs. 16.1 ± 4.7), also seen at M3 and M6 (t-test, p < 0.001). Periodontal treatment was successful in both groups, since it resulted in a reduction of all measured clinical parameters at M3 and M6 (probing pocket depth (PPD), full mouth bleeding and plaque). However, the reduction in PPD was greater in the test group. Conclusions: In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

scholarly journals Alpha activity neuromodulation induced by individual alpha-based neurofeedback learning in ecological context: a double-blind randomized study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Fanny Grosselin ◽  
Audrey Breton ◽  
Lydia Yahia-Cherif ◽  
Xi Wang ◽  
Giuseppe Spinelli ◽  
...  
Keyword(s):  
Brain Activity ◽  
Randomized Study ◽  
Alpha Activity ◽  
Controlled Study ◽  
Control Group ◽  
Learning Context ◽  
Psychological Outcome ◽  
Double Blind ◽  
Wearable Eeg ◽  
Significant Difference

AbstractThe neuromodulation induced by neurofeedback training (NFT) remains a matter of debate. Investigating the modulation of brain activity specifically associated with NF requires controlling for multiple factors, such as reward, performance, congruency between task and targeted brain activity. This can be achieved using sham feedback (FB) control condition, equating all aspects of the experiment but the link between brain activity and FB. We aimed at investigating the modulation of individual alpha EEG activity induced by NFT in a double-blind, randomized, sham-controlled study. Forty-eight healthy participants were assigned to either NF (n = 25) or control (n = 23) group and performed alpha upregulation training (over 12 weeks) with a wearable EEG device. Participants of the NF group received FB based on their individual alpha activity. The control group received the auditory FB of participants of the NF group. An increase of alpha activity across training sessions was observed in the NF group only (p < 0.001). This neuromodulation was selective in that there was no evidence for similar effects in the theta (4–8 Hz) and low beta (13–18 Hz) bands. While alpha upregulation was found in the NF group only, psychological outcome variables showed overall increased feeling of control, decreased anxiety level and increased relaxation feeling, without any significant difference between the NF and the control groups. This is interpreted in terms of learning context and placebo effects. Our results pave the way to self-learnt, NF-based neuromodulation with light-weighted, wearable EEG systems.

scholarly journals Comparing Intravenous Dexamethasone, Pethidine, and Ketamine for Postoperative Shivering Prevention in Patients Undergoing General Anesthesia

2021 ◽  
Vol 27 (3) ◽  
pp. 288-301
Author(s):  
Mohsen Saheban Maleki ◽  
◽  
Sepide Sedaghati Ansari ◽  
Fateme Rezaniazave ◽  
Alireza Talai ◽  
...  
Keyword(s):  
General Anesthesia ◽  
Orthopedic Surgery ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Fourth Group ◽  
The Third ◽  
Dexamethasone Group ◽  
Significant Difference ◽  
Age Range

Aims: Postoperative shivering is unpleasant and annoying for the patient, occurring in up to 65% of cases undergoing general anesthesia. Various mechanisms were suggested for postoperative shivering. Shivering after anesthesia can cause complications, such as cardiovascular conditions, bleeding, and infection. This study compared the effects of dexamethasone, pethidine, and ketamine on the prevention of shivering after general anesthesia. Methods & Materials: In total, 164 patients with ASA classes one and two in the age range of 20-60 years under general anesthesia with orthopedic surgery, urology, and general surgery were included in the study. This study was a double-blind, randomized, placebo-controlled study. The study patients were divided into 4 groups of 41 subjects. After the induction of anesthesia and before surgery, in the first group, dexamethasone 0.15 mg/kg body weight, in the second group, ketamine 0.5 mg/kg, in the third group, pethidine 0.5 mg/kg, and in the fourth group, normal saline 0.9% were all given in 2 cc volume. After surgery, the examined patients were monitored for visible shivering by the researcher. The obtained data were analyzed using SPSS. Findings: The frequency and severity of shivering were lower in the dexamethasone (P=0.009), pethidine (P=0.004), and the ketamine (P=0.000) groups, compared to the control group. Besides, there was a significant difference between each of these 3 groups and the controls. The frequency and severity of shivering in the dexamethasone group were not significantly different from those of the pethidine group (P=0.565). The frequency and severity of shivering in the dexamethasone and ketamine groups were not statistically significant (P=0.071). The frequency and severity of shivering in the pethidine group with ketamine were not statistically significant (P=0.063). Conclusion: The obtained results indicated that dexamethasone, pethidine, and ketamine were effective in preventing postoperative shivering. There was no difference between these medications in the prevention of postoperative shivering.

Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting

2017 ◽  
Vol 126 (2) ◽  
pp. 268-275 ◽  
Author(s):  
Tong J. Gan ◽  
Peter Kranke ◽  
Harold S. Minkowitz ◽  
Sergio D. Bergese ◽  
Johann Motsch ◽  
...  
Keyword(s):  
Postoperative Nausea ◽  
Elective Surgery ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Double Blind ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant

Abstract Background Two essentially identical, randomized, double-blind, placebo-controlled, parallel-group phase III studies evaluated the efficacy of intravenous amisulpride, a dopamine D2/D3 antagonist, in the prevention of postoperative nausea and vomiting in adult surgical patients. Methods Adult inpatients undergoing elective surgery during general anesthesia and having at least two of the four Apfel risk factors for postoperative nausea and vomiting were enrolled at 9 U.S. and 10 European sites. A single 5-mg dose of amisulpride or matching placebo was given at induction of anesthesia. The primary endpoint was complete response, defined as no vomiting/retching and no use of antiemetic rescue medication in the 24-h postoperative period. Nausea incidence was a secondary endpoint. Results Across the two studies, 689 patients were randomized and dosed with study medication, of whom 626 were evaluable per protocol. In the U.S. study, 46.9% (95% CI, 39.0 to 54.9) of patients achieved complete response in the amisulpride group compared to 33.8% (95% CI, 26.2 to 42.0) in the placebo group (P = 0.026). In the European study, complete response rates were 57.4% (95% CI, 49.2 to 65.3) for amisulpride and 46.6% (95% CI, 38.8 to 54.6) for placebo (P = 0.070). Nausea occurred less often in patients who received amisulpride than those who received placebo. There was no clinically significant difference in the safety profile of amisulpride and placebo; in particular, there were no differences in terms of QT prolongation, extrapyramidal side effects, or sedation. Conclusions One of the two trials demonstrated superiority, while pooling both in a post hoc change to the plan of analysis supported the hypothesis that amisulpride was safe and superior to placebo in reducing the incidence of postoperative nausea and vomiting in a population of adult inpatients at moderate to high risk of postoperative nausea and vomiting.

Controlled Study of Linear Growth in Asthmatic Children During Treatment With Inhaled Glucocorticosteroids

PEDIATRICS ◽  
1992 ◽  
Vol 89 (5) ◽  
pp. 839-842
Author(s):  
Ole D. Wolthers ◽  
Søren Pedersen
Keyword(s):  
Growth Velocity ◽  
Linear Growth ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Group 14 ◽  
Double Blind ◽  
Asthmatic Children ◽  
Parallel Group ◽  
Significant Difference ◽  
Inhaled Budesonide

Linear growth was investigated with weekly knemometry in a population of 43 schoolchildren with mild asthma treated with inhaled budesonide. The design was a randomized, double-blind, parallel group study with three dose groups of 200, 400, and 800 µg of budesonide per day. Each dose group received budesonide for 8 consecutive weeks. Placebo was given for either 4 weeks before or after budesonide treatment. Twelve children in the 200-µg group, 14 in the 400-µg group, and 12 in the 800-µg group completed the 12-week study period. There was no significant difference in mean growth velocity among the three dose groups during placebo treatment. Compared with placebo (growth velocity: 0.39 mm/wk), mean lower leg growth velocity was reduced with 0.26 mm/wk (P &lt; .001, t = 5.0, df = 11; 95% confidence interval 0.14 to 0.37 mm/wk) in children treated with 800 µg of budesonide. There was no statistically significant difference in growth velocity between 200- or 400-µg budesonide treatments and placebo. These data indicate that inhaled budesonide can be safely used in doses up to 400 µg/d in schoolchildren with asthma.

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