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).

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.