Background Arthroscopic shoulder surgery causes severe postoperative pain. An interscalene brachial plexus block provides adequate analgesia, but unintended spread of the local anesthetic administered may result in a phrenic nerve block, usually associated with a nonnegligible incidence of acute hemidiaphragmatic paralysis. The main purpose of this trial will be to analyze the incidence of hemidiaphragmatic paralysis ensuing after interscalene brachial plexus block in patients undergoing arthroscopic shoulder surgery administered a standard volume (20 ml) vs. a low volume (10 ml) of levobupivacaine 0.25%. Methods This will be a prospective double-blind randomized controlled single-center two-arm comparative trial. Forty-eight patients will be included. The primary goal will be to ultrasonographically determine the incidence of hemidiaphragmatic paralysis by calculating the diaphragmatic thickness ratio in each group. The secondary goals will be to compare the two arms in terms of (1) decrease in forced vital capacity and (2) in forced expiratory volume at 1 s by spirometry; (3) decrease in diaphragmatic excursion by ultrasound; (4) 24-h total intravenous morphine consumption; (5) time to first opioid request of a patient-controlled analgesia pump; and (6) postoperative complications. Discussion This trial will demonstrate that a low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis following arthroscopic shoulder surgery according to spirometry and ultrasound measurements and does not provide inferior postoperative analgesia to the standard volume, as measured by opioid requirements. Trial registration EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (registered on 7 January 2020). ClinicalTrials.gov identification number: NCT04385966 (retrospectively registered on 8 May 2020). Ethics Committee approval: EC19/093 (18 December 2019).

Summary The interscalene brachial plexus block is recommended for analgesia after shoulder surgery but it may cause hemidiaphragmatic dysfunction. We tested whether ipsilateral hemidiaphragmatic contraction was better after a smaller dose of local anaesthetic without impairing analgesic effect. We randomly allocated 48 adults to 10 ml or 20 ml levobupivacaine 0.25% before arthroscopic shoulder surgery. The primary outcome was hemidiaphragmatic paralysis, defined as inspiratory thickness < 1.2 times expiratory thickness, measured by ultrasound 4 h after block. Hemidiaphragmatic paralysis was recorded for 6/24 vs. 23/24 supine participants after 10 ml vs. 20 ml levobupivacaine 0.25%, respectively, and for 4/24 vs. 23/24 sitting participants, respectively, p < 0.001 for both. Pain scores after 10 ml injectate were not worse than after 20 ml injectate. Median (IQR [range]) morphine doses in the first 24 postoperative hours after 10 ml and 20 ml levobupivacaine 0.25% were 2 (0–6 [0–23]) mg vs. 1 (0–2 [0–11]) mg, respectively, p = 0.12. No participant had a complication after 10 ml interscalene levobupivacaine, whereas seven had complications after 20 ml levobupivacaine, p = 0.009. Hemidiaphragmatic function was better after 10 ml vs. 20 ml interscalene levobupivacaine 0.25% without impairing analgesia for 24 postoperative hours.

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Background: Mastectomy is associated with acute and chronic postoperative pain. This study investigated the efficacy of thoracic paravertebral block (TPB) compared to local anesthetic of surgical wound (LASW) in breast cancer patients undergoing mastectomy. Methods: This phase 3, randomized controlled, single blind, parallel arms and superiority clinical trial aimed to evaluate the efficacy of TPB compared to LASW on acute pain at rest and motion at 24 hours post-mastectomy, measured by a visual analog scale (VAS). The study size of 60 patients is determined to have 90% power to detect a difference of 20% in acute pain in favor of TPB. In TPB group use of ultrasound was mandatory to guide puncture of intervertebral space T3 for infiltrating 0.5% bupivacaine at dose of 1.5 mg/kg. In LASW group was used bupivacaine 0.5% at dose of 1.5mg/kg on subcutaneous tissue of surgical area. VAS was used to measure surgical pain at rest and motion in 2,4,6,12 and 24 hours post-operatives for both groups. Trial Registry: ClinicalTrials.gov; Identifier:NCT02609321. Findings: From 08-2015 to 09-2016, 60 breast cancer patients were enrolled; 3 dropped off consent. Mean age was 51 year; 78% had stage II and III; and 65% receive neoadjuvant chemotherapy.There were no significant differences in the VAS pain measurement for the groups of BWT compared to LASW in the 24 hour measurement, neither at rest (P=0.6525) nor in movement (P=0.7929). There were no significant differences in both groups for repeated pain measurements (5 measures mean), total dose of opioid administration, time to first dose of opioids or adverse events. Conclusions: There were not statistical differences for post-mastectomy acute pain in first 24 hours between TPB and LASW patients. According our findings the use of TPB should not routinely recommended for breast cancer patients undergoing mastectomy. Citation Format: Herazo-Maya F, Egurrola J, Restrepo CE, Torres L, Palacios L, Ossa CA, Borrero M, Angel GA, Marquez JJ, Valencia S, Perez A, Oyola JC, Lobo L, Gomez R, Garcia H. Efficacy of thoracic paravertebral block for reducing acute post-mastectomy pain [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-22-04.

Background: Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block provides adequate analgesia, but the spread of local anaesthetics administered causes a phrenic nerve block that entrains a nonnegligible incidence of hemidiaphragmatic paralysis acute.The main objective of this trial is to compare the hemidiaphragmatic paralysis after interscalene brachial plexus block in arthroscopic shoulder surgery, between a standard volume (20 ml) and a low volume (10 ml) of 0.25% levobupivacaine.Methods: This is a comparative, prospective, single-center, double-blind, two-arm randomized controlled trial. Forty-eight patients will be included. The primary end-point is to determine the hemidiaphragmatic paralysis incidence diagnosed by the diaphragmatic thickness ratio in ultrasound. The secondary endpoints are as follows: (1) hemidiaphragmatic paralysis incidence diagnosed by forced vital capacity and (2) forced expiratory volume at 1 second decrease in spirometry; (3) hemidiaphragmatic paralysis incidence diagnosed by using diaphragmatic excursion decrease in ultrasound; (4) postoperative pain regarding 24-hour morphine intravenous total consumption and (5) time to first analgesic consumption of patient-controlled analgesia pump; and (6) postoperative harm between the two trial arms.Discussion: This trial would demonstrate that low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis in arthroscopic shoulder surgery by using spirometry and ultrasound and would not provide inferior postoperative analgesia according to opioid requirements of postoperative patient-controlled analgesia in comparison to the standard volume used in current practice.Trial registration: EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (Registered on 07 January 2020). ClinicalTrials.gov identification number: NCT04385966 (Retrospectively registered on 08 May 2020). Ethics Committee approval: EC19/093 (18 Dic 2019).

Das Syndrom der polyzystischen Ovarien (PCOS) ist eines der häufigsten gynäkologisch-endokrinologischen Krankheitsbilder und stellt erhebliche Anforderungen an die diagnostischen und therapeutischen Möglichkeiten des Frauenarztes. Für den Gynäkologen ergeben sich viele Möglichkeiten der Prävention der unterschiedlichsten Erkrankungen. Das PCOS gehört zu den Erkrankungen aus dem Formenkreis der hyperandrogenämischen Erkrankungen und ist hier von den anderen Störungen des Androgenhaushaushaltes abgrenzbar. Auch wenn es bereits immer bekannt war, wurde es erst durch die Publikation von Stein und Leventhal 1935 allgemein bekannt und damit Teil der medizinischen Literatur (Abb. 1) [1]. Seitdem ist das PCOS Gegenstand praktisch fast aller gynäkologischen Lehrbücher und wird besonders von gynäkologischen Endokrinologen wissenschaftlich bearbeitet. Wichtig erscheint festzustellen, dass das PCOS mit seinen langjährigen Konsequenzen erhebliches Potenzial zur primären Prävention ernsthafter Erkrankungen in sich trägt. So ergeben sich Möglichkeiten der Präven-tion von Folgeerkrankungen, wie z. B.: Insulinresistenz und Diabetes mellitus • Hyperöstrogenämie und dadurch Folgeprobleme • wie Endometriumhyperplasie und Endometriumkarzinom Verfestigung der Ovarialinsuffizienz mit den sekun-• dären Problemen der Sterilität Störungen des Lipidstoffwechsels mit deutlich er-• höhten kardiovaskulären Risiken Die Therapie des PCOS trägt zusammen mit Lebens stiländerungen zur primären Prävention langfristiger Folgeerkrankungen bei. Zusätzlich besteht die Möglichkeit, durch deutliche Interventionen die Risiken, die sich aus Problemen des Lebensstils ergeben, langfristig zu verbessern.