REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system.

INTRODUCTION: Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future. METHODS AND ANALYSIS: In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping. ETHICS AND DISSEMINATION: The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol. TRIAL REGISTRATION NUMBER: NCT04606264.

Age and Perioperative Outcomes After Implementation of an Enhanced Recovery After Surgery Pathway in Women Undergoing Major Prolapse Repair Surgery.

OBJECTIVE: As perioperative care pathways are developed to improve recovery, there is a need to explore the impact of age. The aim of this study was to compare the impact of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway on perioperative outcomes across 3 age categories: young, middle age, and elderly. METHODS: A retrospective cohort study was conducted assessing same-day discharge, opioid administration, pain scores, and complications differences across and within 3 age categories, young (<61 years), middle age (61-75 years), elderly (>75 years), before and after ERAS implementation. RESULTS: Among 98 (25.7%) young, 202 (52.9%) middle-aged, and 82 (21.5%) elderly women, distribution before and after ERAS implementation was similar. In each age category, we found a commensurate increase in same-day discharge and decrease in length of stay independent of age. Age was associated with a variable response to opioid administration after ERAS. In women who received opioids, we found there was a greater reduction in opioids in elderly. Young women received 22.5 mg more than middle-aged women, whereas elderly women received 24.3 mg less than middle-aged women (P < 0.0001, P < 0.0001) for a mean difference of 46.8 mg between the youngest and oldest group. We found no significant differences in postanesthesia care unit pain scores with ERAS implementation. Complications did not increase after ERAS implementation in any age group, although younger and elderly women were more likely to experience complications independent of ERAS. CONCLUSIONS: Elderly women had similar outcomes compared with their younger counterparts after implementation of an ERAS pathway. Further research is needed to assess whether our age-related observations are generalizable.

Subdural Hematoma Associated With Labor Epidural Analgesia: A Case Series.

OBJECTIVE: This report aimed to describe the characteristics and impact of subdural hematoma (SDH) after labor epidural analgesia. CASE REPORTS: Eleven obstetric patients had SDHs associated with the use of labor epidural analgesia over 7 years at a tertiary care hospital. Ten of 11 patients had signs consistent with postdural puncture headache before the diagnosis of SDH. Five patients (45%) had a recognized unintentional dural puncture, 1 (9%) had a combined spinal-epidural with a 24-gauge needle, and 5 (45%) had no recognized dural puncture. For 10 of the 11 cases, SDH was diagnosed at a mean of 4.1 days (range, 1-7 days) after performance of labor epidural analgesia; one case was diagnosed at 25 days. Ten (91%) of 11 cases had a second hospital stay for a mean of 2.8 days (range, 2-4 days) for observation, without further requirement for neurosurgical intervention. One case (9%) had decompressive hemicraniectomy after becoming unresponsive. The observed rate of labor epidural analgesia-associated SDH was 0.026% (11 in 42,969, approximately 1:3900), and the rate of SDH was 1.1% (5 in 437, approximately 1:87) if a recognized dural puncture occurred during epidural catheter placement. CONCLUSIONS: Subdural hematoma after labor epidural anesthesia is rare but potentially more common than historically estimated. Cases of postdural puncture headache after labor epidural anesthesia should be monitored closely for severe neurologic signs and symptoms that could herald SDH.