STUDY OBJECTIVE This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVR... more STUDY OBJECTIVE This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVRA) with a lower, less toxic, local anesthetic dosage is non-inferior to an upper arm (UA) IVRA in providing a surgical block in patients undergoing hand and wrist surgery. DESIGN Observer-blinded, randomized non-inferiority study. SETTING Operating room. PATIENTS 280 patients undergoing hand surgery were randomly assigned to UA IVRA (n = 140) or FA IVRA (n = 140). INTERVENTIONS Forearm IVRA or upper arm IVRA in patients undergoing hand and wrist surgery. MEASUREMENTS The primary outcome was block success rate of both techniques. Block success was defined as no need of additional analgesics. A second, alternative non-inferiority outcome was defined as no need of conversion to general anesthesia. A difference in success rate of <5% was considered non-inferior. Secondary endpoints were tourniquet pain measured with a Numerical Rating Scale (0-10), satisfaction of patients and surgeons, onset time, surgical time and total OR time. MAIN RESULTS Non-inferiority of block success rate, defined as no need of additional analgesics or conversion to general anesthesia was inconclusive (5.24%, 95% CI:-4.34%,+14.82%). Non-inferiority of no need of conversion to general anesthesia was confirmed (+0.73%, 95% CI:-0.69%,+2.15%). No differences were observed in onset time (FA: 5 (5, 8) vs UA: 6 (5, 7) min, p = 0.74), surgical time (FA: 8 (5, 12) vs UA: 7 (5, 11) min, p = 0.71), nor total OR stay time (FA: 34 (27, 41) vs UA: 35 (32, 39) min, p = 0.09). Tourniquet pain after 10 min was significantly lower after FA IVRA compared to UA IVRA (FA: 2.00 (0.00, 4.00) vs UA: 3.00 (1.00,5.00) min, p = 0.003). CONCLUSION We failed to demonstrate non-inferiority of forearm IVRA with a lower dosage of LA in providing a surgical block without rescue opioids and LA. Non-inferiority of no need of conversion to general anesthesia was confirmed.
BACKGROUND There is growing evidence that the analgesic effect of metamizole is mediated at least... more BACKGROUND There is growing evidence that the analgesic effect of metamizole is mediated at least partly by central mechanisms, including the endocannabinoid/endovanilloid system. Consequently, metamizole may have additive or even synergistic analgesic effects with paracetamol and nonsteroidal anti-inflammatory drugs (NSAID). OBJECTIVE This study aimed to assess if triple therapy with metamizole, ibuprofen and paracetamol (MIP) is superior to double therapy with ibuprofen and paracetamol (i.p.) in treating pain at home after ambulatory arthroscopic shoulder surgery. DESIGN/SETTING/PATIENTS/INTERVENTION In this double-blind, controlled, high-volume single centre, superiority trial, 110 patients undergoing elective ambulatory arthroscopic shoulder surgery were randomised to receive either MIP (n = 55) or i.p. (n = 55) orally for 4 days between December 2019 and November 2021. Pain intensity at movement and rest, using a numeric rating scale (NRS), perceived pain relief, use of rescue medication and adverse effects of study medication were recorded at the post-anaesthesia care unit (PACU) and on postoperative day (POD) 1 to 4 and 7. Quality of Recovery (QoR) and satisfaction with study medication were measured at POD 7 with telephone follow-up. MAIN OUTCOME MEASURE The primary outcome measure was postoperative pain intensity on movement measured by an 11-point NRS (where 0 = no pain and 10 = worst pain imaginable) on POD 1. RESULTS For the primary outcome, superiority of MIP in reducing postoperative pain at movement on POD 1 was not confirmed: mean difference NRS [95% confidence interval (CI), −0.08 (−1.00 to 0.84)]. For pain on movement and at rest, no significant differences were found between groups in the PACU nor on POD 1 to 4 or day 7. Nausea was reported significantly more frequently in the metamizole group (22.6 vs. 58.5; P &lt; 0.001). Other adverse effects of study medication, rescue opioid consumption, perceived pain relief, QoR at POD 7, and overall patient satisfaction were similar in both groups. CONCLUSION Clinically, triple oral treatment with metamizole, paracetamol and ibuprofen is not superior to oral paracetamol and ibuprofen in multimodal pain treatment at home after ambulatory arthroscopic shoulder surgery. TRIAL REGISTRATION European Union Clinical Trials Register 2019-002801-23 and Clinicaltrials.gov NCT04082728.
Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have been... more Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have been admitted to the intensive care unit (ICU) often face months of physical disability after discharge. To optimize recovery, it is important to understand the role of musculoskeletal alterations in critically ill patients infected with SARS-CoV-2. The main aim of the present study was to describe the presence and morphology of nemaline bodies found in the skeletal muscle tissue from critically ill patients infected with SARS-CoV-2. In n = 7 patients infected with SARS-CoV-2, ultrastructural characteristics of vastus lateralis muscle obtained on days 1–3 and days 5–8 following ICU admission were investigated in more detail with electron microscopy. Those muscle biopsies consistently showed variable degrees of myofiber necrosis and myofibrillar disorganization. In 4/7 (57%) patients on days 5–8, the Z-line material accumulated into nemaline bodies with a typical lattice-like appearance at higher magnification, similar to that found in nemaline myopathy. This study is the first to describe the disintegration of myofibrils and the accumulation of Z-line material into nemaline bodies in the skeletal muscle tissue obtained from critically ill coronavirus disease-19 patients following ICU admission, which should be interpreted primarily as a non-specific pathological response of extreme myofibrillar disintegration associated with myofiber necrosis.
STUDY OBJECTIVE This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVR... more STUDY OBJECTIVE This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVRA) with a lower, less toxic, local anesthetic dosage is non-inferior to an upper arm (UA) IVRA in providing a surgical block in patients undergoing hand and wrist surgery. DESIGN Observer-blinded, randomized non-inferiority study. SETTING Operating room. PATIENTS 280 patients undergoing hand surgery were randomly assigned to UA IVRA (n = 140) or FA IVRA (n = 140). INTERVENTIONS Forearm IVRA or upper arm IVRA in patients undergoing hand and wrist surgery. MEASUREMENTS The primary outcome was block success rate of both techniques. Block success was defined as no need of additional analgesics. A second, alternative non-inferiority outcome was defined as no need of conversion to general anesthesia. A difference in success rate of <5% was considered non-inferior. Secondary endpoints were tourniquet pain measured with a Numerical Rating Scale (0-10), satisfaction of patients and surgeons, onset time, surgical time and total OR time. MAIN RESULTS Non-inferiority of block success rate, defined as no need of additional analgesics or conversion to general anesthesia was inconclusive (5.24%, 95% CI:-4.34%,+14.82%). Non-inferiority of no need of conversion to general anesthesia was confirmed (+0.73%, 95% CI:-0.69%,+2.15%). No differences were observed in onset time (FA: 5 (5, 8) vs UA: 6 (5, 7) min, p = 0.74), surgical time (FA: 8 (5, 12) vs UA: 7 (5, 11) min, p = 0.71), nor total OR stay time (FA: 34 (27, 41) vs UA: 35 (32, 39) min, p = 0.09). Tourniquet pain after 10 min was significantly lower after FA IVRA compared to UA IVRA (FA: 2.00 (0.00, 4.00) vs UA: 3.00 (1.00,5.00) min, p = 0.003). CONCLUSION We failed to demonstrate non-inferiority of forearm IVRA with a lower dosage of LA in providing a surgical block without rescue opioids and LA. Non-inferiority of no need of conversion to general anesthesia was confirmed.
BACKGROUND There is growing evidence that the analgesic effect of metamizole is mediated at least... more BACKGROUND There is growing evidence that the analgesic effect of metamizole is mediated at least partly by central mechanisms, including the endocannabinoid/endovanilloid system. Consequently, metamizole may have additive or even synergistic analgesic effects with paracetamol and nonsteroidal anti-inflammatory drugs (NSAID). OBJECTIVE This study aimed to assess if triple therapy with metamizole, ibuprofen and paracetamol (MIP) is superior to double therapy with ibuprofen and paracetamol (i.p.) in treating pain at home after ambulatory arthroscopic shoulder surgery. DESIGN/SETTING/PATIENTS/INTERVENTION In this double-blind, controlled, high-volume single centre, superiority trial, 110 patients undergoing elective ambulatory arthroscopic shoulder surgery were randomised to receive either MIP (n = 55) or i.p. (n = 55) orally for 4 days between December 2019 and November 2021. Pain intensity at movement and rest, using a numeric rating scale (NRS), perceived pain relief, use of rescue medication and adverse effects of study medication were recorded at the post-anaesthesia care unit (PACU) and on postoperative day (POD) 1 to 4 and 7. Quality of Recovery (QoR) and satisfaction with study medication were measured at POD 7 with telephone follow-up. MAIN OUTCOME MEASURE The primary outcome measure was postoperative pain intensity on movement measured by an 11-point NRS (where 0 = no pain and 10 = worst pain imaginable) on POD 1. RESULTS For the primary outcome, superiority of MIP in reducing postoperative pain at movement on POD 1 was not confirmed: mean difference NRS [95% confidence interval (CI), −0.08 (−1.00 to 0.84)]. For pain on movement and at rest, no significant differences were found between groups in the PACU nor on POD 1 to 4 or day 7. Nausea was reported significantly more frequently in the metamizole group (22.6 vs. 58.5; P &lt; 0.001). Other adverse effects of study medication, rescue opioid consumption, perceived pain relief, QoR at POD 7, and overall patient satisfaction were similar in both groups. CONCLUSION Clinically, triple oral treatment with metamizole, paracetamol and ibuprofen is not superior to oral paracetamol and ibuprofen in multimodal pain treatment at home after ambulatory arthroscopic shoulder surgery. TRIAL REGISTRATION European Union Clinical Trials Register 2019-002801-23 and Clinicaltrials.gov NCT04082728.
Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have been... more Patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have been admitted to the intensive care unit (ICU) often face months of physical disability after discharge. To optimize recovery, it is important to understand the role of musculoskeletal alterations in critically ill patients infected with SARS-CoV-2. The main aim of the present study was to describe the presence and morphology of nemaline bodies found in the skeletal muscle tissue from critically ill patients infected with SARS-CoV-2. In n = 7 patients infected with SARS-CoV-2, ultrastructural characteristics of vastus lateralis muscle obtained on days 1–3 and days 5–8 following ICU admission were investigated in more detail with electron microscopy. Those muscle biopsies consistently showed variable degrees of myofiber necrosis and myofibrillar disorganization. In 4/7 (57%) patients on days 5–8, the Z-line material accumulated into nemaline bodies with a typical lattice-like appearance at higher magnification, similar to that found in nemaline myopathy. This study is the first to describe the disintegration of myofibrils and the accumulation of Z-line material into nemaline bodies in the skeletal muscle tissue obtained from critically ill coronavirus disease-19 patients following ICU admission, which should be interpreted primarily as a non-specific pathological response of extreme myofibrillar disintegration associated with myofiber necrosis.
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