Trials
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Thoracic epidural anesthesia is no longer considered the gold standard for perioperative analgesia in laparoscopic colorectal procedures. In the search for alternatives, the efficacy of the transverse abdominal plane (TAP) block and other abdominal wall blocks such as the transmuscular quadratus lumborum (TQL) block continues to be investigated for postoperative pain management. Most of the initial studies on TAP blocks reported positive effects; however, the amount of studies with negative outcomes is increasing, most probably due to the fact that the majority of abdominal wall blocks fail to mitigate visceral pain. The TQL block could prove attractive in the search for better postoperative pain relief after laparoscopic colorectal surgery. In several cadaveric studies of the TQL, a spread of dye into the thoracic paravertebral space, the intercostal spaces, and even the thoracic sympathetic trunk was reported. Given the advantage of possibly reaching the thoracic paravertebral space, the potential to reach nerves transmitting visceral pain, and the possible coverage of dermatomes T4-L1, we hypothesize that the TQL provides superior postoperative analgesia for laparoscopic colorectal surgery as compared to patient-controlled intravenous analgesia with morphine alone. ⋯ In this prospective, randomized, double-blind controlled clinical trial, 150 patients undergoing laparoscopic colorectal surgery will be included. Patients will be randomly allocated to two different analgesic strategies: a bilateral TQL with 30 ml ropivacaine 0.375% each on both sides, administered before induction of anesthesia, plus postoperative patient-controlled intravenous analgesia with morphine (TQL group, n = 75), or a bilateral TQL block with 30 ml saline each on both sides plus postoperative patient-controlled intravenous analgesia with morphine (placebo group, n = 75). Our primary outcome parameter will be the morphine consumption during the first 24 h postsurgery. Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)). Epidural analgesia is no longer the standard of care for postoperative analgesia in laparoscopic colorectal surgery. Until now, the most effective analgesic strategy in these patients especially in an enhanced recovery program is still unknown. Several abdominal wall blocks (TAP, fascia transversalis plane block) are known to have an analgesic effect only on somatic pain. Recognizing the importance of procedure-specific pain management, we aim to investigate whether a transmuscular quadratus lumborum block delivers superior pain control in comparison to patient-controlled intravenous analgesia with morphine alone.
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Primary Objective: The primary objective is to reduce initiation of mechanical ventilator dependency in patients with moderate to severe CoViD- 19. This will be measured as the difference between the control group and active group for subjects admitted to the hospital for CoViD-19. Secondary Objectives: • To evaluate cytokine trends / Prevent cytokine storms • To evaluate supplemental oxygen requirements • To decrease mortality of CoViD-19 patients • Delay onset of ventilation TRIAL DESIGN: The study is a single centre, 2-arm, prospective, randomized (ratio 1:1), controlled trial with parallel groups design to compare the reduction of respiratory distress in a CoViD-19 population, using the intervention of the gammaCore®-Sapphire device plus standard of care (active) vs. standard of care alone (SoC) - the control group. The gammaCore® treatments will be used acutely and prophylactically. The active and control groups will be matched for disease and severity. ⋯ The total number of patients to be included in the study is 90, with 45 in each study group TRIAL STATUS: The protocol version is 8.0 from 07th April 2020. The recruitment began 20th April 2020 and is expected to be complete 31st July 2020.
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Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested, owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the present study is to evaluate the effectiveness of acupuncture in treating the symptoms and QoL of patients with moderate or severe AV. ⋯ We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single-center scope, relatively small sample size, and lack of blinding of the acupuncturists.
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An amendment to this paper has been published and can be accessed via the original article.
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An amendment to this paper has been published and can be accessed via the original article.