Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Liver Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Postoperative Complications

Hematinics

All Drugs and Chemicals

Liver Extracts

Yuxia Zhang, Ph.D

PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice.

1. Study design This is a multi-centre, prospective cohort study performed at two tertiary teaching hospitals in Shanghai, China.
2. Settings and participants The study will be conducted in the liver disease department in Fudan University Zhongshan Hospital and Shanghai cancer center. Patients will be prospectively consecutively recruited between may 2024 and August 2024. Patients who are diagnosed with liver cancer and underwent hepatectomy will be eligible. Inclusion criteria are age older than 18 years, planned admissions and elective surgery, and staying at least 24 hours in the surgical unit. We exclude patients with cognitive impairment and patients who had nausea and vomiting related to other existing diseases, such as gastroesophageal reflux disease. We also exclude patients who had severe postoperative complications, including massive abdominal hemorrhage, hepatic encephalopathy and portal vein thrombosis.

   Our study aims to develop PONV prediction model. The rule of thumb in logistic modelling is that there should be a minimum of 10 events per predictor variable (EPV). According to a previous study, the incidence of PONV is 48.3% \[22\] and there are a total of 20 predictor variables, therefore, the required minimum sample size is 414. Considering 15% of the sample loss, we would target to recruit 476 to minimize the limitation of a small number of events of PONV.
3. Data collection PONV risk factor assessments All enrolled patients will receive preoperative PONV risk assessments by the second author and the third author 1 day before surgery. The baseline demographic data and medical history will be recorded. The potential predictors include female sex, nonsmoking history, history of motion sickness or PONV, age, sex, history of smoking, history of motion sickness, history of PONV, duration of surgery, the use of postoperative opioids, the style of surgery and type of surgery, the numbers and time of portal vein occlusion and the use of postoperative opioids. We defined smoking history as nicotine use before surgery, history of motion sickness as nausea or vomiting when travelling in a car/boat/train/plane, and use of postoperative opioids as the use of opioids within the 24 hours after surgery. Nonsmoking history and history of motion sickness or PONV were collected by interviewing patients and family members, while the use of postoperative opioids will be determined by checking the hospital information system to review records and anaesthetic protocols.

   Outcome measures Postoperative nausea and vomiting will be assessed every hour during the first two hours, every two hours for the following four hours and every four hours until the 24th hour by the first and the second authors to ensure high-quality data collection. PONV will be evaluated on a four-grade scale from 0 (no nausea and no vomiting), 1 (having nausea but no vomiting), 2 (having vomiting without stomach contents) to 3 (having vomiting with stomach contents). A patient will be considered to have had PONV if his or her PONV grade is 2 or more within the first 24 postoperative hours. PONV will be assessed by the first author, who is blinded to the results of PONV risk assessments.
4. Statistical analysis The statistical analysis will be performed using SPSS 25.0 and Pyhthon software version 4.0.1. Continuous variables were analysed by using descriptive statistics (median, interquartile range, or mean \[SD\]); categorical data were analyzed as proportions (number, percentage). According to the ratio of 8:2, the data will be divided into training sets and validation sets, and the prediction model of the random forest algorithm will be constructed, the hyperparameter optimization will be carried out, and the importance of each predictor in the random forest model will be calculated by Gini coefficient. The differentiation of the prediction model will be evaluated based on the ROC curve, the calibration curve evaluated the calibration degree of the model, and the prediction performance of the model for PONV will be evaluated. A P value of less than .05 will be considered statistically significant.

A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer

Development and Validation of a Machine Learning Model for Postoperative Nausea and Vomiting in Patients With Liver Cancer

PONV will be evaluated on a four-grade scale from 0 (no nausea and no vomiting), 1 (having nausea but no vomiting), 2 (having vomiting without stomach contents) to 3 (having vomiting with stomach contents).

Shanghai Zhongshan Hospital

Skin and Connective Tissue Diseases

Nervous System Diseases

Pain, Postoperative

Breast Neoplasms

Syndrome

Pain

Systemic Inflammatory Response Syndrome

Neurologic Manifestations

Inflammation

Shock

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Kristin J Steinthorsdottir, MD

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after breast cancer surgery, with removal of the breast (mastectomy). Primary outcome is the proportion patients who require transfer to the post anaesthesia care unit (PACU) and the proportion that can be transferred directly to the ward. Secondary outcomes are organospecific complications in the postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery.

The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.

The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.

Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.

Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.

Based on positive results in other procedure-specific studies, all mastectomy patients at Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg dexamethasone injection since mid-2015. This has resulted in a decrease in the proportion of patients who need observation in PACU from 30 % to 10 %. The reduction is primarily due to less pain, less sedation, and lower opioid administration.

Whether this is also partly due to a "systemic effect" (Hawthorn effect) as a result of increased focus on the area cannot be excluded.

Prior to creating clinical recommendations and standards, it is required that the results be tested in a randomized, controlled, clinical trial.

The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV have been shown in numerous trials, and is already being administered to all patients at the clinic. It would therefore not be ethically correct to withdraw from this practise.

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial

Number of patients meeting criteria for transfer to PACU post-surgery

Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM) discharge score.Construct: The score consists of six modalities (subscores): Sedation,Oxygen saturation,blood pressure,heart rate,pain (at rest)and nausea.Each modality has a score between 0 and 3,and patients are considered dischargeable to the ward when the score sum of all criteria (total score) is 4 or less and no single score is above 1. All values (subscores) are considered best at 0 and worst at 3.

Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping aroused by physical stimuli, 3 sleeping cannot be aroused.

Oxygen saturation (%):0 ≥94, 1 90-93, 2 85-89, 3 \<85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or \>220, 3\<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 \<40 or \>130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting.

DASAIM score (Danish Society of Anesthesiology and Intensive Care Medicine). The score consists of six modalities: Sedation, Oxygen saturation, blood pressure, heart rate, pain (at rest) and nausea.

Each modality has a score between 0 and 3, and patients are considered dischargeable to the ward when the score sum of all criteria is four or less and no single score is above one.

Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping, aroused by physical stimuli, 3 sleeping, cannot be aroused.

Oxygen saturation (%): 0 ≥ 94, 1 90-93, 2 85-89, 3 \<85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or \>220, 3\<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 \<40 or \>130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting.

complications requiring treatment until discharge

Length of stay in the post-anesthesia care unit (PACU), measured as hours and minutes, from start of procedure, to discharge from PACU

Length of stay in hospital, measured from start of procedure to discharge from hospital to home

Secondary transfer to PACU from ward, or to intensive care unit from PACU

Self-reported pain (worst and average (average through that day), days 0-4) on a numeric rating scale (NRS) 0-10. 0 is no pain, 10 is worst pain imaginable.. Questionnaire.

Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting

Self-reported quality of sleep (days 0-4). Questionnaire. Dichotomized to Good sleep or sleep problems, numbers reported are number of patients with sleep problems

Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes)

Seroma, requiring treatment the first 14 days.

Rigshospitalet, Denmark

Principal investigator, MD, Clinical assistant

Adverse events are collected from patients that received the study drug (63 and 64 in the 8 and 24 mg group respectively), we had 3 post-randomization exclusion, they did not receive the study drug and adverse events were not collected in agreement with the Good Clinical Practise (GCP) monitor

Dexamethasone 8 mg pre-operative

Dexamethasone: pre-operative intravenous administration

Dexamethasone 8 mg

Dexamethasone 24 mg pre-operative

Dexamethasone: pre-operative intravenous administration

Dexamethasone 24 mg

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

kristin steinthorsdottir, md

primary outcome was per intention to treat, secondary outcomes were per protocol (we had 3 post-randomization exclusions, that did not receive the intervention)

Transfer to Post-anesthesia Care Unit (PACU)

Discharge Score,(Modified Aldrete Discharge Score), Operating Room

Discharge Score, Arrival at PACU

Discharge Score, Arrival at Ward

Number of Participants With Complication

Total Length of Stay in PACU

Total Length of Stay in Hospital

Secondary Transfer

Day 0, average

Day 1, average

Day 2, average

Day 3, average

Day 4, average

Day 0, worst

Day 1, worst

Day 2, worst

Day 3, worst

Day 4, worst

Pain, Numeric Rating Scale

DAY 0

DAY 1

DAY 2

DAY 3

DAY 4

Post Operative Nausea and Vomiting (PONV).

Quality of Sleep

DAY 0 : restlessness

DAY 0 : sadness

DAY 0 : fatigue

DAY 1 : restlessness

DAY 1 : sadness

DAY 1 : fatigue

DAY 2 : restlessness

DAY 2 : sadness

DAY 2 : fatigue

DAY 3 : restlessness

DAY 3 : sadness

DAY 3 : fatigue

DAY 4 : restlessness

DAY 4 : sadness

DAY 4 : fatigue

Mental Status

Number of Participants With Seroma, Requiring Treatment

Readmission

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Chronic Pain

Urinary Bladder Neoplasms

Chronic Graft Versus Host Disease

Central Nervous System Depressants

Analgesics

Anesthetics

Ropivacaine

Single shot bilateral QLB, ropivacaine 75 mg (20 mL) per side, placed under ultrasound control, at the end of surgery. 22 patients will be allocated in this group.

Epidural catheter (placed before anesthesia induction), ropivacaine 75 mg in 50 mL isotonic saline (1,5 mg/mL), induction bolus after surgery 1 mL/10 kg ideal weight and there on continuous infusion 2-8 mL/h according to analgesic need. 22 patients will be allocated in this group.

This is the current standard for postoperative pain relief in cystectomy patients in our hospital

bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle

Maija-Liisa Kalliomaki, PhD

There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours.

Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.

44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural.

The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Patients are randomized and allocated in blocks of ten to either epidural of QLB group

QLB and Radical Cystectomy, Postoperative Pain

Comparing Two Different Analgesic Block Methods for Postoperative Pain and Recovery After Surgery -Quadratus Lumborum Block (QLB): the Effect on Peri- and Postoperative Pain and Recovery After Radical Cystectomy

numerical rating scale and amount of vomites

assessment how pain in operation region limits daily functions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer	NCT06356623	Nausea and Vomi... Liver Cancer	1	18 Years - 80 Years	Shanghai Zhongshan Hospital
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy	NCT03125941	Dexamethasone Glucocorticoids Mastectomy Breast Cancer Pain, Postopera... Nausea and Vomi... Steroid Systemic Inflam... Postoperative C...	Dexamethasone	18 Years -	Rigshospitalet, Denmark
QLB and Radical Cystectomy, Postoperative Pain	NCT03328988	Postoperative P... Chronic Pain Po... Nausea and Vomi...	QLB	18 Years - 85 Years	Tampere University Hospital
A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer	NCT06356623	Nausea and Vomi... Liver Cancer	1	18 Years - 80 Years	Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for nausea and vomiting, postoperative