The PROMISE study protocol: a multicenter prospective study of process optimization with interdisciplinary and cross-sectoral care for German patients receiving hip and knee endoprostheses.

Background and purpose - Knee and hip replacement are common and increasing procedures, and an optimized care process that could be implemented in different settings would be useful. The PROMISE trial investigates whether a new care process works equally in different German settings and how the results compare with current non-standardized care.Patients and methods - This multi-center prospective mixed-method study includes 2,000 German patients receiving arthritis-related hip or knee endoprostheses. An interdisciplinary and cross-sectoral care process was developed and implemented in 3 German hospitals with different levels of care, and corresponding rehabilitation centers were included to bridge the gap after acute care.Duration and outcome - The PROMISE trial recruited patients between May 2018 and March 2020. Follow-up will end in February 2021. Assessments are performed at: examination on clinical indication, 1 week before surgery, on the day of surgery, at the end of hospitalization, end of the rehabilitation program, and 3 months, 6 months, and 12 months after surgery. Outcomes include patient-reported outcomes, medical examination findings, and routinely collected data regarding the surgery and complications. Guideline-based interviews are conducted with selected patients and care partners. The primary endpoint is the presence of chronic pain at 12 months after surgery. Secondary endpoints are the number of recognized pre-existing conditions, physical activity at 12 months after surgery, use of medical services, quality of life, and interactions between care partners.Trial registration - The trial is registered with the German Clinical Trials Register (https://www.drks.de; DRKS00013972; March 23, 2018).

Insertion of the ProSeal™ laryngeal mask airway is more successful with the Flexi-Slip™ stylet than with the introducer.

PURPOSE: The ProSeal™ laryngeal mask airway (PLMA™) may be difficult to insert because of its large soft cuff, even when using a dedicated introducer tool. The purpose of this study was to investigate whether introduction of a stylet (Flexi-Slip™) in the drainage tube improved insertion characteristics compared with the standard introducer. METHODS: In this randomized controlled trial, 160 adults were allocated randomly to either the Introducer group (n = 80) or to the Flexi-Slip stylet group (n = 80). In the Introducer group, the PLMA was inserted with an introducer as described in the manufacturer's instructions. In the Flexi-Slip stylet group, a Flexi-Slip stylet was inserted into the drainage tube of the PLMA and bent to form a near 90° angle at the junction of the cuff and the airway tube. The primary outcome measurement was the success rate at first attempt. Insertion time, visible blood staining, and complications were also noted. RESULTS: Success at first attempt was more frequent with the Flexi-Slip stylet than with the introducer (100% vs 86%, respectively; P = 0.001). Overall time (mean ± standard deviation) taken for successful placement was shorter with the Flexi-Slip stylet than with the introducer (19.9 ± 5.6 sec vs 28.4 ± 15.2 sec, respectively; P < 0.001). The incidences of blood staining and postoperative sore throat were lower in the Flexi-Slip stylet group than in the Introducer group (4% vs 15%, respectively; P = 0.015 and 8% vs 23%, respectively; P = 0.008). CONCLUSION: Insertion of the PLMA with a Flexi-Slip stylet has a higher success rate at first attempt, requires less time, and results in fewer airway complications than the introducer technique.

Combined subdural and epidural block in a case of epidural catheterization for postoperative analgesia.

We report a case of unusual block caused by postoperative epidural analgesia for laparotomy in a gynecologic patient in consequence of inadvertent epidural catheterization. The clinical manifestation included agitation, spotty distribution of analgesia, wide spread of sensory block and loss of motor power. The radiological findings suggested a multicompartmental block with the anchorage of the catheter tip stretching over the epidural and subdural spaces. The default of catheter position was not detected during routine test dose procedure.

Evaluation of the effects of caudal or cephalic epidural catheterization on the characteristics of lumbar epidural anesthesia.

BACKGROUND: The delayed and incomplete sensory block of the sacral roots in epidural anesthesia often results from too huge the size of the first sacral nerve root. To overcome the problem, the enhancement of anesthetic effect on the sacral segment by injecting the local anesthetic toward the caudal direction has been reported. Thus, in this study, we compared the anesthetic effects of epidural anesthesia by catheterization toward caudal direction with that toward cephalic direction on the areas innervated by the sacral nerve roots. METHODS: The study enrolled 45 ASA physical status I or II patients scheduled for ankle surgery or hemorrhoidectomy who were randomly and evenly divided into two groups. The epidural catheter was placed either cephalad (EU group) or caudad (ED group) and confirmed by C-arm fluoroscopy after catheter insertion. Each group finally consisted of 10 patients for ankle surgery and 10 for hemorrhoidectomy after exclusion of the ineligibles. The onset time, duration of, and recovery time from epidural anesthesia, as well as demand of intra-operative analgesic in the two groups were recorded and compared. RESULTS: No significant differences were noted in the patients' characteristics between the two groups. There were also no statistically significant differences in onset, duration, recovery time, and anesthetic level attained between the two groups. More patients in the EU group demanded analgesics during surgery than did patients in the ED group. However, there were no statistically significant differences in the rate of analgesic demand between the two groups. CONCLUSIONS: Epidural injection of local anesthetic via catheter oriented caudad or cephalad did not change the characteristics of epidural anesthesia including onset time, duration, anesthetic level, and analgesic effect on the surgical areas innervated by the sacral roots.