Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Bupivacaine

Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.

Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.

PECS II: Ultrasound guided block involving injection of 20 ml of 0.25% L-bupivacaine with dexmetomidine into an interfascial plane between the serratus anterior muscle and the external intercostal muscles followed by the needle withdrawal into an interfascial plane between the pectoralis major and pectoralis minor muscle where further 10ml will be administered.

PIFB: Ultrasound guided block involving injection of 10 ml of 0.25% L-bupivacaine with dexmetomidine into an iterfascial plane between the pectoralis major and the intercostal muscles approximately 2 cm laterally from the sternum to cover T2 to T6 dermatomes.

Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)

Tomas Hitka, MD

Roman Zahorec, MD

The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.

Breast cancer is a devastating disease. Surgery is the mainstay of treatment which can lead to ongoing patient difficulties. Severe acute pain after surgery is one of major risk factors for developing persistent postsurgical pain. Subsequent physiological stress caused by this severe pain may negatively influence the immune response leading to a worse prognosis.

Regional anesthesia is very effective in management of peri- and postoperative pain. Epidural block, paravertebral block and intercostal nerve blocks have been proven over time to be effective in preventing postoperative pain. However, their widespread use has been hampered by technical difficulty and inherent risks.

Unlike the aforementioned blocks, novel thoracic wall blocks, namely modified pectoralis block (PECS II) and pecto-intercostal fascial block (PIFB) are safe, simple and effective.

Efforts to prolong and improve analgesia following single shot blocks has led to the introduction of adjuvants into the local anesthetic. Dexmetomidine is a superselective Alpha 2 agonist with a proven ability to prolong the duration of neuraxial, peripheral nerve and interfascial plane blocks.

Chronic inflammation is recognized as a risk factor for initiation, progression and further spread of malignant growth. Surgical insult leads to inflammatory response which facilitates the development of a metastatic disease. Many inflammatory markers were proven to be independent prognostic factors in breast cancer patients.

The investigators propose to study the impact of novel thoracic wall blocks with dexmetomidine on simple inflammatory markers obtained from full blood count (NLR, PLR, NPR, PDW, MPV, RDW) after breast cancer surgery.

120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).

Intervention will be done under general anesthesia so participant will be blinded and primary outcome which will be laboratory test will be assessed by a person not aware of intervention.

Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery

Incidence of postsurgical pain at 1month, 2month and 3 months

Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery

Difference in Δ NLR, PLR, NPR, PDW, MPV and RDW between the intervention group and the standard care group measured at 24 hours after breast cancer surgery

Numeric rating scale for pain (NRS, 0-10, where 0 means no pain and 10 the worst pain) at 0, 1h, 6h, 12h,18h,24h after surgery at rest and at ipsilateral arm abduction

Total opioid consumption after surgery at 24 h

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Louis Pasteur University Hospital Kosice

St. Elizabeth Cancer Institute, Slovakia

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Hemorrhage

Pancreatic Neoplasms

Fistula

Gastroparesis

Pancreatic Fistula

Pathological Conditions, Anatomical

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Paralysis

Neurologic Manifestations

Digestive System Fistula

Quality of Life

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

ERAS protocol

Despoina Liotiri, Consultant

Alexandros Diamantis, Consultant

Eleni Siwka, Consultant

Ismini Paraskeva, Trainee

Dimitrios Zacharoulis, Professor

Eleni Arnaoutoglou, Professor

The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery.

This prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.

In this study the ERAS program is applied to patients undergoing pancreatic surgery.This is a prospective observational cohort study.The study will take place in two hospitals, the University General Hospital of Larissa (academic center), and IASO Thessalias (largest private general hospital in Thessaly). The study period is three years between May 2022 and April 2025. All patients undergoing pancreatic surgery during this period will be invited to participate in the study. Recruitment will take place at the first appointment with the surgeon when the patient is listed for surgery. The patient will be provided with detailed information about the program which also includes an information leaflet. A written consent form will be signed by patients willing to participate in the study.

Enrolled patients will follow the ERAS pathway for pancreatic surgery during the preoperative, intraoperative, and postoperative period. The ERAS protocol is based on ERAS society recommendations for enhanced recovery after pancreatoduodenectomy.

The ERAS protocol consists of the following items:

First appointment preoperative:

* Patient education about the program
* Prehabilitation with advice on physical exercise and nutritional support
* Advice to stop smoking and alcohol consumption
* Plan for optimisation of comorbidities
* Completion of quality of life questionnaire

Day before surgery:

* Discussion about the program to address any patient concerns and anxieties
* Light meal and carbohydrate drink before bedtime
* Anti-clotting injection 12 hours before surgery

Day of surgery:

* Carbohydrate drink and painkillers 3 hours before surgery
* Clear fluids allowed up to 3 hours before surgery
* Antibiotics within 1 hour before surgical incision

Intraoperative

* Epidural catheter is sited before general anaesthesia
* Multimodal and opioid-sparing analgesia
* Nausea and vomiting prophylaxis
* Goal directed fluid therapy
* Active warming to avoid hypothermia
* Monitoring of blood glucose to maintain normoglycaemia
* Bile culture
* Repeat antibiotics if surgery lasts more than 4 hours

Postoperative:

* Removal of nasogastric tube by postoperative day 1
* Removal of drains by postoperative day 3
* Multimodal analgesia, epidural catheter for 3 days, minimisation of opioids
* Early and scheduled mobilisation and respiratory physiotherapy protocol
* Diet protocol with nutritional drinks and gradual progression from light to solid diet by postoperative day 5
* Removal of urinary catheter when patients able to mobilise on their own, by postoperative day 5
* Cessation of intravenous fluids when patients able to drink 1.5 liters of water, by postoperative day 5
* Regular gastrokinetic medication and gum chewing
* Glycaemic control protocol
* Cessation of antibiotics if bile culture negative and no other indication to continue

The study group will use a checklist with ERAS criteria to follow for each patient and data will be collected on adherence rates to these criteria.

Data will be collected on patient demographics such as sex, age, Body Mass Index (BMI), American Society of Anaesthesiologists (ASA) physical status, and co-morbidities. Data will also be collected on surgical approach and technique, and tumour stage (pTNM). Data will be collected on complications including cardiovascular and respiratory complications, infectious complications (surgical site infection, chest infection, urinary tract infection, intra-abdominal abscess, sepsis), anaesthetic complications (severe pain, delirium, cognitive decline), functional complications (functional decline, new mobility aid use, pressure ulcer, discharge to nursing or rehabilitation facility), renal failure, ileus, return to theatre, readmission, and death. Data will be collected on length of stay and pancreatic surgery-specific complications such as DGE, PPH and POPF formation. International consensus guidelines will be used for definition and grading of these complications.

Quality of life will be assessed by Patient Reported Outcome Measures (PROMS). The stress response will be assessed by measuring NLR and PLR. After anonymization, all data will be prospectively uploaded by local investigators on a protected database and incorporated into a spreadsheet for data analysis.

The data will be analyzed using PROMs, NLR and PLR ratios, postoperative complications, length of hospital stay and cancer recurrence rates as the main outcome variables.The influence of the following factors will be assessed: age, BMI, sex, surgical technique, pTNM stage, preoperative comorbidity, ASA classification, previous SARS-CoV-2 infection, and compliance to the ERAS protocol (\<50%, 50-70%, 70-90%, \>90%). Adherence will be calculated as the number of interventions fulfilled/20 (total number of preoperative and perioperative interventions).

The statistical model will be multivariate regression analysis. Sample size guidelines for observational studies with regression analysis are based on simulation studies and suggest that the minimum number of events per variable (EPV) should be 10. According to these guidelines the minimum sample size is calculated at 90. To account for 25% loss to follow-up the investigators aim for a total enrollment goal of 120 participants. IBM® SPSS 26 software will be used for statistical analysis. Continuous variables will be compared with One-Way ANOVA or Student's t test for parametric data and with a non-parametric test (Mann-Whitney U test or Kruskal-Wallis test), as indicated. Categorical data will be analysed by using the chi squared or Fisher's exact test where indicated. Quantitative values will be expressed as mean ± standard deviation (SD), median and range, categorical data with percentage frequencies. The odds ratio (OR) will be presented followed by 95% confidence interval (95% CI). Differences in survival and complications between different degrees of compliance will be assessed by the application of log rank test. P \< 0.05 will be considered statistically significant.

Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes

Enhanced Recovery Program, Patient Reported Outcomes, Surgery-specific Outcomes and Stress Response After Pancreatic Surgery: A Prospective Observational Cohort Study by the Thessalic Pancreas Study Group (ThePANas).

This questionnaire assesses health related quality of life (HRQoL) for cancer patients and includes 30 questions. The QLQ-C30 includes five functional scales (physical, role, emotional, cognitive, and social functioning); eight symptom scales or single items (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, and diarrhea); an item to assess financial difficulties; 1 global health status scale; and 1 global quality of life scale. Each one of the first 28 items has 4 levels: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The last 2 questions ask the patient to rate their own health and quality of life on a scale from 1 (very poor) to 7 (excellent). PROMs questionnaires will be distributed in paper format and filled out by pen.

NLR and PLR will be calculated by blood tests

Number of DGE defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).

Number of POPF defined and graded according to the International Study Group of Pancreatic Fistula (ISGPF).

Number of PPH defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).

Total number of days spent in the hospital (including any readmission)

Number of any perioperative adverse events graded according to Clavien-Dindo

Number of patients with cancer recurrence with metastases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery	NCT04860115	Inflammatory Ma...	Modified pector...	18 Years -	St. Elizabeth Cancer Institute, Slovakia
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery	NCT04860115	Inflammatory Ma...	Modified pector...	18 Years -	St. Elizabeth Cancer Institute, Slovakia
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes	NCT05518643	ERAS Pancreas Cancer Pancreas; Fistu... Delayed Gastric... Surgery-Complic... Pancreatic Hemo... PROMs	ERAS protocol	18 Years -	University of Thessaly
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes	NCT05518643	ERAS Pancreas Cancer Pancreas; Fistu... Delayed Gastric... Surgery-Complic... Pancreatic Hemo... PROMs	ERAS protocol	18 Years -	University of Thessaly

Spots Global Cancer Trial Database for nlr

Every month we try and update this database with for nlr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nlr

Every month we try and update this database with for nlr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nlr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.