scholarly journals Effects of regional anesthesia techniques on local anesthetic plasma levels and complications in carotid surgery: a randomized controlled pilot trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Thomas Rössel ◽  
Christopher Uhlig ◽  
Jörg Pietsch ◽  
Stefan Ludwig ◽  
Thea Koch ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Pilot Study ◽  
Regional Anesthesia ◽  
Local Anesthetic ◽  
Plasma Levels ◽  
Statistical Significance ◽  
Pilot Trial ◽  
Ultrasound Guided ◽  
Nerve Paralysis ◽  
Randomized Controlled

Abstract Background The ultrasound guided intermediate cervical plexus block with perivascular infiltration of the internal carotid artery (PVB) is a new technique for regional anesthesia in carotid endarterectomy (CEA). We conducted a pilot study investigating the effects of deep cervical block (DCB), intermediate cervical block alone (ICB) and PVB on perioperative complications in patients undergoing elective CEA. We hypothesized, that the ropivacaine plasma concentration is higher in patients receiving DCB compared to PVB and ICB. Methods In a randomized controlled pilot study thirty patients scheduled for elective CEA were randomly assigned into three groups: DCB receiving 20 mL ropivacaine 0.5% (n = 10), ICB receiving 20 mL ropivacaine 0.5% (n = 10) and PVB receiving 20 mL ropivacaine 0.5% and 10 mL ropivacaine 0,3% (n = 10). As primary outcome, plasma levels of ropivacaine were measured with high performance liquid chromatography before, 5, 10, 20, 60, and 180 min after the injection of ropivacaine. Secondary outcomes were vascular and neurological complications as well as patients’ and surgeons’ satisfaction. All analyses were performed on an intention-to-treat basis. Statistical significance was accepted at p < 0.05. Results No conversion to general anesthesia was necessary and we observed no signs of local anesthetic intoxication or accidental vascular puncture. Plasma concentration of ropivacaine was significantly higher in the DCB group compared to PVB and ICB (p < 0.001) and in the PVB group compared to ICB (p = 0.008). Surgeons’ satisfaction was higher in the PVB group compared to ICB (p = 0.003) and patients’ satisfaction was higher in the PVB group compared to ICB (p = 0.010) and DCB group (p = 0.029). Phrenic nerve paralysis was observed frequently in the DCB group (p < 0.05). None of these patients with hemi-diaphragmatic paralysis showed signs of respiratory distress. Conclusion The ultrasound guided PVB is a safe and effective technique for CEA which is associated with lower plasma levels of local anesthetic than the standard DCB. Considering the low rate of complications in all types of regional anesthesia for CEA, larger randomized controlled trials are warranted to assess potential side effects among the blocks. Trial registration The trial was registered at German Clinical Trials Register (DRKS) on 04/05/2019 (DRKS00016705, retrospectively registered).

scholarly journals Fructus MumeFormula in the Treatment of Type 2 Diabetes Mellitus: A Randomized Controlled Pilot Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Xiang Tu ◽  
ChunGuang Xie ◽  
Fei Wang ◽  
Qiu Chen ◽  
ZhiHuang Zuo ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Blood Glucose ◽  
Pilot Study ◽  
Controlled Trial ◽  
Glycosylated Hemoglobin ◽  
Pilot Trial ◽  
Randomized Controlled

Background. “Fructus Mumeor Dark Plum” (pilule form) has been used for many years in Traditional Chinese Medicine (TCM) and may be a valid treatment for type 2 diabetes mellitus (T2DM).Aim. One aspect toward efficacy validation is the evaluation of the blood glucose-lowering effect ofFructus Mume(FM) with T2DM patients in a randomized controlled trial (RCT).Methods. This pilot study uses a RCT procedure to assess efficacy ofFMand Metformin. The trial was for 12 weeks, with 80 T2DM subjects. Both groups were standardized in their diet and exercise routine. Comparisons of several variables were analyzed.Results. No significant differences were found between groups in the fasting and postprandial glucose levels although both had significant decreases. The values of glycosylated hemoglobin were significantly reduced in both groups. For patients whose body mass index (BMI) was <23, neitherFMnor Metformin had an effect on BMI; for those with a BMI between 23 and 25 or the BMI was >25, bothFMand Metformin significantly reduce the BMI.Conclusions. In this pilot study, it was demonstrated thatFructus Mumeformula may reduce the levels of blood glucose in patients with type 2 diabetes.

Ultrasound-guided genitofemoral nerve block for inguinal hernia repair in the male adult: a randomized controlled pilot study

2018 ◽  
Vol 84 (2) ◽  
Author(s):  
Luciano FRASSANITO ◽  
Bruno A. ZANFINI ◽  
Sara PITONI ◽  
Paolo GERMINI ◽  
Miryam DEL VICARIO ◽  
...  
Keyword(s):  
Inguinal Hernia ◽  
Pilot Study ◽  
Hernia Repair ◽  
Inguinal Hernia Repair ◽  
Nerve Block ◽  
Ultrasound Guided ◽  
Male Adult ◽  
Genitofemoral Nerve ◽  
Randomized Controlled

Electroacupuncture versus manual acupuncture for knee osteoarthritis: a randomized controlled pilot trial

2020 ◽  
Vol 38 (5) ◽  
pp. 291-300 ◽  
Author(s):  
Tian-Qi Wang ◽  
Yong-Ting Li ◽  
Li-Qiong Wang ◽  
Guang-Xia Shi ◽  
Jian-Feng Tu ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Statistical Significance ◽  
Pilot Trial ◽  
Controlled Clinical Trial ◽  
Acupuncture Points ◽  
Womac Pain ◽  
Manual Acupuncture ◽  
Current Output ◽  
Randomized Controlled ◽  
And Function

Objective: We aimed to explore the feasibility of evaluating the comparative effectiveness and safety of electroacupuncture (EA) relative to manual acupuncture (MA) for the treatment of knee osteoarthritis (KOA). Methods: A multicenter randomized controlled clinical trial was conducted in Beijing from September 2017 to January 2018. A total of 60 participants with KOA were randomly allocated to either EA ( n = 30) or MA ( n = 30) groups. Participants in the EA group were treated with EA at six to seven local traditional acupuncture points or ah shi points, and two to three distal points. Participants in the MA group had the same schedule as the EA group except that the electrical apparatus featured a working power indicator without actual current output, constituting a sham EA procedure, in order to blind participants. Both groups received 24 sessions over 8 weeks. The primary outcome was response rate, defined as a change of ⩾50% from baseline in the total scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) after 8 weeks. Secondary outcomes included pain, stiffness, function, quality of life, and acupuncture-related adverse events (AEs) at 4 and 8 weeks. Results: Of 60 participants randomized, 53 (88%) completed the study. Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis. Although significant differences were observed in WOMAC pain, stiffness, and function scores within both groups, between-group differences at 8 weeks did not reach statistical significance (odds ratio = 1.75 (95% confidence interval = 0.593–5.162)). Rates of AEs were low and similarly distributed between groups. Conclusion: Both EA and MA interventions in KOA were feasible and appeared safe. Whether or not EA may have a stronger impact on pain and function requires further evaluation through larger, adequately powered, randomized controlled trials. Trial registration number: NCT03274713.

scholarly journals Physiotherapeutic scoliosis-specific exercises performed immediately after spinal manipulative therapy for the treatment of mild adolescent idiopathic scoliosis: study protocol for a randomized controlled pilot trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Li Wang ◽  
Chun Wang ◽  
Ahmed S. A. Youssef ◽  
Jiang Xu ◽  
Xiaolin Huang ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adolescent Idiopathic Scoliosis ◽  
Cobb Angle ◽  
Pilot Trial ◽  
Three Dimensional ◽  
Spinal Manipulative Therapy ◽  
Research Society ◽  
Scoliosis Research Society ◽  
Manipulative Therapy ◽  
Randomized Controlled

Abstract Background Spinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modalities seems reasonable, but the effectiveness of this combination has never been rigorously tested. Here, a protocol for a pilot study is proposed to determine the feasibility of conducting a larger randomized trial. The pilot study was designed to test the hypothesis that spinal manipulative therapy followed by PSSE is more effective than PSSE alone in improving the Cobb angle, sensorimotor integration, the angle of trunk rotation (ATR), body symmetry, and quality of life. Methods The protocol describes a randomized controlled pilot trial with 40 subjects divided into study and control groups. Both groups will receive 8 weeks of PSSE, but the study group will also receive spinal manipulative therapy during the first 2 weeks before PSSE. The primary outcome will be an estimate of the feasibility of conducting a full-scale experiment. The influencing factors will be the time to complete enrollment, the recruitment rate, subject retention, and adherence to the treatment allocations. The secondary outcomes that will be used to assess the efficacy of treatment will include the Cobb angle, somatosensory evoked potentials, ATR, three-dimensional postural parameters, and scores on the 22-item Scoliosis Research Society outcomes questionnaire. The Cobb angle will be measured at baseline and at the end of 8 weeks of training. The somatosensory evoked potentials will be measured at baseline and at the end of 2 weeks of training. The ATR, three-dimensional postural parameters, and scores on the 22-item Scoliosis Research Society outcomes questionnaire will be measured at baseline and at 2 weeks, 4 weeks, and 8 weeks of treatment. Discussion This study will inform the design of a future full-scale trial. The outcomes will provide preliminary data about the efficacy of the combination of spinal manipulative therapy and exercise in treating scoliosis. Trial registration Prospectively registered at Chinese clinical trial registry, ChiCTR1900027037. Registered on 29 October 2019. http://www.chictr.org.cn/edit.aspx?pid=44954&htm=4

scholarly journals Use of smart glasses for ultrasound-guided peripheral venous access: a randomized controlled pilot study

2019 ◽  
Vol 6 (4) ◽  
pp. 356-361
Author(s):  
Hyunmook Lim ◽  
Min Joung Kim ◽  
Joon Min Park ◽  
Kyung Hwan Kim ◽  
Junseok Park ◽  
...  
Keyword(s):  
Pilot Study ◽  
Venous Access ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Smart Glasses ◽  
Peripheral Venous Access
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