U.S. federal regulations for research involving exception from informed consent (EFIC) include stipulations for community consultation (CC) and public disclosure (PD) (FDA 21 CFR 50.24). Published ...descriptions of PD campaigns include letters to community leaders, media outreach, paid advertising, and community meetings. Whether or not these activities provide measurable impact is unknown, as few prior works have evaluated PD activities with probabilistic polling. The aim of this study is to use polling to assess how much public awareness PD efforts generate.
A 3-month PD campaign similar in scope and scale to PD campaigns described in several recent publications was implemented across a large urban county (pop. 2.55 million). PD included a study website (www.evktrial.org), letters to 300 community leaders/organizations, bilingual media outreach and also phased roll-outs, weeks apart, of newspaper advertisements, mass e-mail messaging, and paid advertising in Facebook® and Twitter® augmented by volunteer social media outreach. During PD we used repeated zip code-targeted online polling via Google Consumer Surveys® to assess community awareness of the proposed EFIC study.
Over 3-months all-source exposures to >1 million individuals were estimated, generating ∼5,000 website visits (12-month cumulative, ∼9000). However, general community awareness evaluated through repeated county-wide polling never rose above baseline measurements. CC/PD campaign costs were estimated at $60,000 (USD).
A PD campaign in scope and scale common for EFIC studies may not provide measurable impact in a community. Investigators, review boards and regulators could consider these findings when re-examining and/or creating policies for PD for EFIC studies.
Purpose
Etomidate and ketamine are hemodynamically stable induction agents often used to sedate critically ill patients during emergency endotracheal intubation. In 2015, quality improvement data ...from our hospital suggested a survival benefit at Day 7 from avoidance of etomidate in critically ill patients during emergency intubation. In this clinical trial, we hypothesized that randomization to ketamine instead of etomidate would be associated with Day 7 survival after emergency endotracheal intubation.
Methods
A prospective, randomized, open-label, parallel assignment, single-center clinical trial performed by an anesthesiology-based Airway Team under emergent circumstances at one high-volume medical center in the United States. 801 critically ill patients requiring emergency intubation were randomly assigned 1:1 by computer-generated, pre-randomized sealed envelopes to receive etomidate (0.2–0.3 mg/kg,
n
= 400) or ketamine (1–2 mg/kg,
n
= 401) for sedation prior to intubation. The pre-specified primary endpoint of the trial was Day 7 survival. Secondary endpoints included Day 28 survival.
Results
Of the 801 enrolled patients, 396 were analyzed in the etomidate arm, and 395 in the ketamine arm. Day 7 survival was significantly lower in the etomidate arm than in the ketamine arm (77.3% versus 85.1%, difference − 7.8, 95% confidence interval − 13, − 2.4,
p
= 0.005). Day 28 survival rates for the two groups were not significantly different (etomidate 64.1%, ketamine 66.8%, difference − 2.7, 95% confidence interval − 9.3, 3.9,
p
= 0.294).
Conclusion
While the primary outcome of Day 7 survival was greater in patients randomized to ketamine, there was no significant difference in survival by Day 28.
Fascia iliaca compartment block (FICB) has been shown to provide excellent pain relief in patients undergoing total hip arthroplasty (THA). However, the analgesic efficacy of FICB, in comparison with ...periarticular infiltration (PAI) for THA, has not been evaluated. This randomized, controlled, observer-blinded study was designed to compare suprainguinal FICB (SFICB) with PAI in patients undergoing THA via posterior approach.
After institutional review board approval, 60 consenting patients scheduled for elective THA were randomized to one of two groups: ultrasound-guided SFICB block or PAI. The local anesthetic solution for both the groups included 60 mL ropivacaine 300 mg and epinephrine 150 µg. The remaining aspects of perioperative care, including general anesthetic and non-opioid multimodal analgesic techniques, were standardized. An investigator blinded to group allocation documented pain scores at rest and with movement and supplemental opioid requirements at various time points. Patients were evaluated for sensory changes and quadriceps weakness in the operated extremity.
There were no differences between the groups with respect to demographics, intraoperative opioid use, duration of surgery, recovery room stay, nausea scores, need for rescue antiemetics, time to ambulation and time to discharge readiness as well as 48 hours postoperative opioid requirements. The pain scores at rest and with movement also were similar at all time points. Significantly more patients in the SFICB group experienced muscle weakness at 6 hours after surgery.
Under the circumstances of our study, in patients undergoing THA, SFICB provided the similar pain relief compared with PAI, but was associated with muscle weakness at 6 hours postoperatively.
NCT02658240.
Purpose
Lumbar spine surgery is associated with significant postoperative pain. The benefits of erector spinae plane blocks (ESPBs) combined with multimodal analgesia has not been adequately studied. ...We evaluated the analgesic effects of bilateral ESPBs as a component of multimodal analgesia after open lumbar laminectomy.
Methods
Analgesic effects of preoperative, bilateral, ultrasound-guided ESPBs combined with standardized multimodal analgesia (
n
= 25) was compared with multimodal analgesia alone (
n
= 25) in patients undergoing one or two level open lumbar laminectomy. Other aspects of perioperative care were similar. The primary outcome measure was cumulative opioid consumption at 24 h. Secondary outcomes included opioid consumption, pain scores, and nausea and vomiting requiring antiemetics on arrival to the post-anesthesia care unit (PACU), at 24 h, 48 h, and 72 h after surgery, as well as duration of the PACU and hospital stay.
Results
Opioid requirements at 24 h were significantly lower with ESPBs (31.9 ± 12.3 mg vs. 61.2 ± 29.9 mg, oral morphine equivalents). Pain scores were significantly lower with ESPBs in the PACU and through postoperative day two. Patients who received ESPBs required fewer postoperative antiemetic therapy (
n
= 3, 12%) compared to those without ESPBs (
n
= 12, 48%). Furthermore, PACU duration was significantly shorter with ESPBs (49.7 ± 9.5 vs. 79.9 ± 24.6 min).
Conclusions
Ultrasound-guided, bilateral ESPBs, when added to an optimal multimodal analgesia technique, reduce opioid consumption and pain scores, the need for antiemetic therapy, and the duration of stay in the PACU after one or two level open lumbar laminectomy.
Regional nerve blocks are an effective method of managing acute pain associated with surgery. The relative benefit of preoperative versus postoperative peripheral nerve blocks is not entirely clear. ...The primary aim of this study was to determine differences in pain scores in patients undergoing preoperative block versus postoperative block versus no block. We hypothesized that patients receiving preoperative blocks would have reduced pain scores and decreased opioid use in the immediate postoperative period. We conducted a retrospective cohort analysis of 302 consecutive patients undergoing unilateral open reduction and internal fixation of ankle fracture under general anesthesia. We identified 3 groups: preoperative block, postoperative block, or no block. Data obtained from our electronic medical records included demographic information, postanesthesia care unit length of stay, pain scores obtained preoperatively, upon arrival to the postanesthesia care unit, and upon discharge from the postanesthesia care unit as well as intraoperative and postanesthesia care unit opioid utilization. Patients receiving preoperative block had significantly lower pain scores, less intraoperative or postanesthesia care unit opioid use, and shorter postanesthesia care unit dwell time compared with patients receiving postoperative block or no block. Preoperative popliteal sciatic and adductor canal blocks in patients undergoing ankle fracture surgery appears to be more effective than either postoperative block or no block.
Regional anesthesia is frequently employed in efforts to improve postoperative analgesia and reduce opioid requirements following abdominal surgery. The purpose of the current analysis was to ...determine if there was a difference in postoperative pain and opioid consumption between patients who underwent open total abdominal hysterectomy (TAH) and received ultrasound-guided bilateral transversus abdominis plane (TAP) blocks using either liposomal bupivacaine or ropivacaine. A single-center retrospective analysis was conducted of 215 patients from November 2018 through March 2020 who underwent an open TAH and received bilateral TAP blocks with either liposomal bupivacaine or ropivacaine. The primary outcome measure was opioid consumption at regular intervals until discharge, and the secondary outcome measures included pain scores, incidence of nausea/vomiting, and use of antiemetics at the same time intervals. Intraoperative opioid consumption and postanesthesia recovery unit opioid requirements were similar between the two groups. Opioid requirements at 24 hours (P < 0.04) and 48 hours (P < 0.01), as well as total morphine equivalent requirements (P < 0.05), were significantly lower in the liposomal bupivacaine group compared to the ropivacaine group. Patients undergoing open TAH who received liposomal bupivacaine TAP blocks required fewer postoperative opioids to achieve similar pain scores when compared to patients who received ropivacaine TAP blocks.
Background: Multimodal analgesia techniques, including regional analgesia, have been shown to provide effective analgesia and minimize opioid consumption after liver resection surgery. While thoracic ...epidural analgesia (TEA) is considered the gold standard, its role in the current era of enhanced recovery after surgery (ERAS) has been questioned. Erector spinae plane blocks (ESPBs) have the potential to provide effective postoperative analgesia without the risks associated with epidural analgesia. The primary aim of this quality improvement project was to evaluate the analgesic efficacy of ultrasound-guided ESPB in comparison with TEA in patients undergoing open liver resection.Methods: Fifty patients who underwent open liver resection and received TEA (n=25) or ESPB (n=25) as part of an ERAS pathway were retrospectively identified. The primary outcome measure was cumulative postoperative opioid consumption at 24 hours. Secondary outcomes included opioid consumption, pain scores, the incidence of nausea and vomiting requiring antiemetics, lower extremity muscle weakness, and occurrence of hypotension requiring treatment on arrival to the post-anesthesia care unit and at 2, 6, 12, 24 hours, and daily through postoperative day 7. Results: Opioid requirements were significantly lower in the TEA group compared to the ESPB group. Postoperative pain scores at rest and with deep inspiration were significantly lower in the TEA group through postoperative day 5. There were no differences in other outcome measures.Conclusions: These findings suggest that compared with ESPB, TEA provides superior pain relief after open liver resection.
This prospectively designed, clinical quality improvement project compared pain scores and opioid consumption between ultrasound-guided, erector spinae plane blocks (ESPB) and thoracic paravertebral ...blocks (PVB) in patients undergoing total bilateral mastectomies without reconstruction. Twenty-five patients were included in an enhanced recovery pathway and received an ESPB on one side and a PVB on the contralateral side. Numeric rating scores at rest and with movement for each side were recorded in the recovery room at 2, 6, 12, 24, and 48 hours and on days 3 to 7. There were no significant differences in the resting or movement-evoked pain scores between sides receiving ESPB or PVB at any time point up to day 7 after surgery. Both ESPB and PVB confer equal analgesic effects in patients undergoing mastectomies. ESPB provides an alternative to PVB in reducing postoperative pain in patients undergoing mastectomy as part of an enhanced recovery pathway.
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