Three perioperative factors impair host defence against recurrence during cancer surgery: the surgical stress response, use of volatile anaesthetic, and opioids for analgesia. All factors are ...ameliorated by regional anaesthesia-analgesia. We tested the primary hypothesis that breast cancer recurrence after potentially curative surgery is lower with regional anaesthesia-analgesia using paravertebral blocks and the anaesthetic propofol than with general anaesthesia with the volatile anaesthetic sevoflurane and opioid analgesia. A second hypothesis was that regional anaesthesia-analgesia reduces persistent incisional pain.
We did a randomised controlled trial at 13 hospitals in Argentina, Austria, China, Germany, Ireland, New Zealand, Singapore, and the USA. Women (age <85 years) having potentially curative primary breast cancer resections were randomised by computer to either regional anaesthesia-analgesia (paravertebral blocks and propofol) or general anaesthesia (sevoflurane) and opioid analgesia. The primary outcome was local or metastatic breast cancer recurrence. The secondary outcome was incisional pain at 6 months and 12 months. Primary analyses were done under intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT00418457. The study was stopped after a preplanned futility boundary was crossed.
Between Jan 30, 2007, and Jan 18, 2018, 2132 women were enrolled to the study, of whom 24 were excluded before surgery. 1043 were assigned to regional anaesthesia-analgesia and 1065 were allocated to general anaesthesia. Baseline characteristics were well balanced between study groups. Median follow-up was 36 (IQR 24–49) months. Among women assigned regional anaesthesia-analgesia, 102 (10%) recurrences were reported, compared with 111 (10%) recurrences among those allocated general anaesthesia (hazard ratio 0·97, 95% CI 0·74–1·28; p=0·84). Incisional pain was reported by 442 (52%) of 856 patients assigned to regional anaesthesia-analgesia and 456 (52%) of 872 patients allocated to general anaesthesia at 6 months, and by 239 (28%) of 854 patients and 232 (27%) of 852 patients, respectively, at 12 months (overall interim-adjusted odds ratio 1·00, 95% CI 0·85–1·17; p=0·99). Neuropathic breast pain did not differ by anaesthetic technique and was reported by 87 (10%) of 859 patients assigned to regional anaesthesia-analgesia and 89 (10%) of 870 patients allocated to general anaesthesia at 6 months, and by 57 (7%) of 857 patients and 57 (7%) of 854 patients, respectively, at 12 months.
In our study population, regional anaesthesia-analgesia (paravertebral block and propofol) did not reduce breast cancer recurrence after potentially curative surgery compared with volatile anaesthesia (sevoflurane) and opioids. The frequency and severity of persistent incisional breast pain was unaffected by anaesthetic technique. Clinicians can use regional or general anaesthesia with respect to breast cancer recurrence and persistent incisional pain.
Sisk Healthcare Foundation (Ireland), Eccles Breast Cancer Research Fund, British Journal of Anaesthesia International, College of Anaesthetists of Ireland, Peking Union Medical College Hospital, Science Fund for Junior Faculty 2016, Central Bank of Austria, and National Healthcare Group.
This consensus statement presents a comprehensive and evidence-based set of guidelines for the care of postoperative nausea and vomiting (PONV) in both adult and pediatric populations. The guidelines ...are established by an international panel of experts under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anesthesia based on a comprehensive search and review of literature up to September 2019. The guidelines provide recommendation on identifying high-risk patients, managing baseline PONV risks, choices for prophylaxis, and rescue treatment of PONV as well as recommendations for the institutional implementation of a PONV protocol. In addition, the current guidelines focus on the evidence for newer drugs (eg, second-generation 5-hydroxytryptamine 3 5-HT3 receptor antagonists, neurokinin 1 (NK1) receptor antagonists, and dopamine antagonists), discussion regarding the use of general multimodal PONV prophylaxis, and PONV management as part of enhanced recovery pathways. This set of guidelines have been endorsed by 23 professional societies and organizations from different disciplines (Appendix 1).Guidelines currently available include the 3 iterations of the consensus guideline we previously published, which was last updated 6 years ago; a guideline published by American Society of Health System Pharmacists in 1999; a brief discussion on PONV management as part of a comprehensive postoperative care guidelines; focused guidelines published by the Society of Obstetricians and Gynecologists of Canada, the Association of Paediatric Anaesthetists of Great Britain & Ireland and the Association of Perianesthesia Nursing; and several guidelines published in other languages.The current guideline was developed to provide perioperative practitioners with a comprehensive and up-to-date, evidence-based guidance on the risk stratification, prevention, and treatment of PONV in both adults and children. The guideline also provides guidance on the management of PONV within enhanced recovery pathways.The previous consensus guideline was published 6 years ago with a literature search updated to October 2011. Several guidelines, which have been published since, are either limited to a specific populations or do not address all aspects of PONV management. The current guideline was developed based on a systematic review of the literature published up through September 2019. This includes recent studies of newer pharmacological agents such as the second-generation 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, a dopamine antagonist, neurokinin 1 (NK1) receptor antagonists as well as several novel combination therapies. In addition, it also contains an evidence-based discussion on the management of PONV in enhanced recovery pathways. We have also discussed the implementation of a general multimodal PONV prophylaxis in all at-risk surgical patients based on the consensus of the expert panel.
Atrial fibrillation and delirium are common consequences of cardiac surgery. Dexmedetomidine has unique properties as sedative agent and might reduce the risk of each complication. This study ...coprimarily aimed to establish whether dexmedetomidine reduces the incidence of new-onset atrial fibrillation and the incidence of delirium.
A randomised, placebo-controlled trial was done at six academic hospitals in the USA. Patients who had had cardiac surgery with cardiopulmonary bypass were enrolled. Patients were randomly assigned 1:1, stratified by site, to dexmedetomidine or normal saline placebo. Randomisation was computer generated with random permuted block size 2 and 4, and allocation was concealed by a web-based system. Patients, caregivers, and evaluators were all masked to treatment. The study drug was prepared by the pharmacy or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation. Participants were given either dexmedetomidine infusion or saline placebo started before the surgical incision at a rate of 0·1 μg/kg per h then increased to 0·2 μg/kg per h at the end of bypass, and postoperatively increased to 0·4 μg/kg per h, which was maintained until 24 h. The coprimary outcomes were atrial fibrillation and delirium occurring between intensive care unit admission and the earlier of postoperative day 5 or hospital discharge. All analyses were intention-to-treat. The trial is registered with ClinicalTrials.gov, NCT02004613 and is closed.
798 patients of 3357 screened were enrolled from April 17, 2013, to Dec 6, 2018. The trial was stopped per protocol after the last designated interim analysis. Among 798 patients randomly assigned, 794 were analysed, with 400 assigned to dexmedetomidine and 398 assigned to placebo. The incidence of atrial fibrillation was 121 (30%) in 397 patients given dexmedetomidine and 134 (34%) in 395 patients given placebo, a difference that was not significant: relative risk 0·90 (97·8% CI 0·72, 1·15; p=0·34). The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99–2·23). Safety outcomes were clinically important bradycardia (requiring treatment) and hypotension, myocardial infarction, stroke, surgical site infection, pulmonary embolism, deep venous thrombosis, and death. 21 (5%) of 394 patients given dexmedetomidine and 8 (2%) of 396 patients given placebo, had a serious adverse event as determined by clinicians. 1 (<1%) of 391 patients given dexmedetomidine and 1 (<1%) of 387 patients given placebo died.
Dexmedetomidine infusion, initiated at anaesthetic induction and continued for 24 h, did not decrease postoperative atrial arrhythmias or delirium in patients recovering from cardiac surgery. Dexmedetomidine should not be infused to reduce atrial fibrillation or delirium in patients having cardiac surgery.
Hospira Pharmaceuticals.
Felcisetrag (5-hydroxytryptamine-4 receptor 5-HT
agonist) is under investigation as prophylaxis or active treatment for accelerating resolution of gastrointestinal function post-surgery.
Phase 2, ...randomized, placebo-controlled, parallel five-arm, double-blind, multicenter study (NCT03827655) in 209 adults undergoing open or laparoscopic-assisted bowel surgery. Patients received intravenous placebo, felcisetrag 0.1 mg/100 mL or 0.5 mg/100 mL pre-surgery only, or pre-surgery and daily post-surgery until return of gastrointestinal function or for up to 10 days.
time to recovery of gastrointestinal function.
Median time to recovery of gastrointestinal function was 2.6 days for both felcisetrag 0.5 mg daily and 0.5 mg pre-surgery versus 1.9 days for placebo (p > 0.05). There were no notable differences in adverse events between treatment arms.
Felcisetrag was well tolerated with no new safety concerns. However, no clinically meaningful difference in time to recovery of gastrointestinal function versus placebo was observed. Further investigation of the utility of 5-HT
agonists in complicated, open abdominal surgeries may be warranted.
Incidence of, and potential risk factors for, postoperative gastrointestinal dysfunction (POGD) after gastrointestinal procedures performed in US hospitals were examined.
This retrospective study ...used hospital discharge data of inpatients who underwent ≥1 gastrointestinal procedures from 1-Jan-2016 to 30-Apr-2019. POGD incidence was calculated based on all hospitalizations for MDC-06 procedures. Predictors of POGD were assessed using multivariable logistic regression.
POGD incidence was 5.8% among 638 611 inpatient hospitalizations. Major bowel procedures, peritoneal adhesiolysis, and appendectomy were the most notable predictors of POGD among gastrointestinal procedures assessed (adjusted odds ratios 95% confidence intervals: 2.71 2.59–2.83, 2.48 2.34–2.64, and 2.15 2.03–2.27, respectively; all p < 0.05). Procedures performed by colorectal/gastroenterology specialists (0.86 0.84–0.89), and those performed percutaneously (0.55 0.54–0.56) were associated with significantly lower odds of POGD (both P < 0.05).
Findings may help clinicians tailor management plans targeting patients at high-risk of POGD.
•The incidence of POGD among 638 611 hospitalizations for GI procedures was 5.8%.•Major bowel procedures, adhesiolysis, and appendectomy were predictors of POGD.•Lower risk of POGD with colorectal/gastroenterology specialist involvement.•Procedures performed percutaneously were associated with lower odds of POGD.
Abstract
Objective
The utility of single-injection and continuous peripheral nerve blocks is limited by short duration of analgesia and catheter-related complications, respectively. This ...double-blind, multicenter trial evaluated the efficacy, safety, and pharmacokinetics of single-injection, ultrasound-guided brachial plexus block (BPB) with liposomal bupivacaine (LB) added to a standardized pain management protocol for shoulder surgery.
Methods
Adults undergoing total shoulder arthroplasty or rotator cuff repair were randomized to receive LB 133 mg, LB 266 mg (pharmacokinetic and safety analyses only), or placebo, added to a standardized analgesia protocol. The primary end point was area under the curve (AUC) of visual analog scale pain intensity scores through 48 hours postsurgery. Secondary end points were total opioid consumption, percentage of opioid-free patients, and time to first opioid rescue through 48 hours. Pharmacokinetic samples were collected through 120 hours and on days 7 and 10. Adverse events were documented.
Results
One hundred fifty-five patients received treatment (LB 133 mg, N = 69; LB 266 mg, N = 15; placebo, N = 71). BPB with LB 133 mg was associated with significantly improved AUC of pain scores (least squares mean SE = 136.4 12.09 vs 254.1 11.77, P < 0.0001), opioid consumption (least squares mean SE = 12.0 2.27 vs 54.3 10.05 mg, P < 0.0001), median time to opioid rescue (4.2 vs 0.6 h, P < 0.0001), and percentage of opioid-free patients (treatment difference = 0.166, 95% confidence interval = 0.032–0.200, P = 0.008) through 48 hours vs placebo. Adverse event incidence was comparable between groups.
Conclusions
Single-injection BPB with LB 133 mg provided analgesia through 48 hours postsurgery with reduced opioid use compared with placebo after shoulder surgery.
Objective
To evaluate the impact of a QI initiative to reduce post‐caesarean opioid use.
Design
Retrospective cohort study.
Setting
Academic hospital in the USA.
Population
Women over 18 years ...undergoing caesarean section.
Methods
A quality improvement (QI) initiative titled Reduced Option for Opioid Therapy (ROOT) was implemented in women undergoing caesarean section. The intervention included implementation of a postpartum order set maximising the use of scheduled NSAIDs and acetaminophen. Additionally, nursing education promoted non‐opioid therapy as first‐line, with opioids reserved for breakthrough pain. Performance feedback was provided to nursing staff on a bimonthly basis. Post‐caesarean opioid use was reviewed in the 6 months before and after implementation of ROOT.
Main outcome measures
The primary outcome was the total morphine milligram equivalents (MME) consumed during the postpartum admission. Secondary outcomes included opioid use per postoperative day, the proportion of opioid‐free admissions, the percentage of patients discharged with a prescription for opioids, prescription size, and pain scores.
Results
Following implementation of ROOT, median inpatient opioid use decreased by more than 60%, from 75 to 30 MME per admission (P < 0.001). The proportion of opioid‐free admissions increased from 12.6% pre‐intervention to 30.7% post‐intervention (P < 0.001). Additionally, the median opioid dose prescribed at discharge decreased in the post‐intervention cohort, and the proportion of patients discharged without an opioid prescription increased. The reduction in opioids was associated with a slight decrease in patient‐reported pain scores.
Conclusions
Implementation of ROOT significantly reduced opioid use while achieving comparable pain control.
Tweetable
Nursing education, and use of an order set prioritising non‐opioid analgesics reduces post‐caesarean opioid use.
Tweetable
Nursing education, and use of an order set prioritising non‐opioid analgesics reduces post‐caesarean opioid use.
This article includes Author Insights, a video available at https://vimeo.com/bjogs/authorinsights17094
Spinal anesthesia is a common anesthetic used in many surgical procedures. Anatomical variations and diseases make this procedure require extra considerations. Extra care should be taken into ...consideration in the pre-anesthesia evaluation when neuraxial anesthesia is planned.We present the case of a patient undergoing cesarean section for the arrest of labor, who had a complicated labor course due to unrecognized history of a tethered spinal cord leading to inadequate analgesia, requiring replacement of epidural analgesia and spinal anesthesia. Ultimately, the decision was made to proceed with general anesthesia due to the patient’s discomfort. Exhaustive chart review after surgery showed a past MRI with evidence of a tethered spinal cord.
Total joint arthroplasties are among the most common elective procedures performed in the United States, and they are associated with postoperative pain. Gabapentin enacarbil is a prodrug with an ...extended-release formulation that has been proposed for multimodal postoperative analgesia, but the drug's efficacy for major arthroplasties remains unclear.
We enrolled 60 adult patients scheduled for primary knee or hip arthroplasty expected to remain hospitalized for at least 3 days. Eligible patients were randomly assigned to placebo or gabapentin enacarbil 600 mg twice daily starting the day before surgery continuing for 3 days thereafter.The primary outcome was analyzed using a joint hypothesis framework of pain (0 to 10 verbal response scores) and cumulative opioid consumption (mg of morphine equivalent) within the first 72 hours. Secondary outcomes were nausea and vomiting, pain persisting 90 days after surgery, duration of hospitalization, and early postoperative health status using quality of recovery score (QoR-15).
Twenty-eight patient in gabapentin enacarbil group and 32 in placebo group were analyzed. Since pain scores did not differ significantly (difference of means: -0.2 in pain scores; 95% confidence interval: -1.1, 0.7), nor did opioid consumption, conditions for joint hypothesis testing were not met. Moreover, there were no significant differences between groups for secondary outcomes.
We did not identify statistically significant or clinically meaningful differences in our primary and secondary outcomes related to perioperative use of gabapentin enacarbil in patients having primary hip or knee arthroplasties.
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