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2023-03-20
2023-07-20
2023-07-30
65
NCT06254430
Ankara City Hospital Bilkent
Ankara City Hospital Bilkent
OBSERVATIONAL
Effects of Erector Spina Plan Block and Epidural Analgesia in Whipple Surgery
Pancreatic surgery is generally a high-risk and difficult to manage perioperatively. surgery. In pancreatic surgery, in addition to general anaesthesia, central blocks for analgesia and peripheral blocks are also preferred. In this study, in patients undergoing whipple surgery epidural and erector spina plan block (ESP) may cause intraoperative and postoperative pain, renal functions and haemodynamic variables.
Pancreatic surgery and anaesthetic management is a difficult operation due to the anatomical location and function of the pancreas. Thoracic epidural anaesthesia/analgesia (TEA) in addition to general anaesthesia in upper abdominal surgeries such as pancreas, liver and stomach.Thoracic epidural analgesia (TEA) is the most widely used gold standard in this type of surgery. TEA may cause haemodynamic changes in patients due to decreased sympathetic tone due to sympathetic nerve blockade. In elderly patients, bradycardia and hypotension is observed more frequently. Cardiovascular response decreases with age due to decreased cardiac reserve and deterioration of the autonomic nervous system and arteriolar structure. This can lead to this is because more segments are blocked than in younger patients. Pain control with thoracic epidural will provide pulmonary rehabilitation and rapid mobilisation. Accordingly, thromboembolic events, atelectasis and pulmonary infections are prevented. However, it has important unwanted side effects such as hypotension, dural puncture and contralateral block. All these disadvantages of TEA has increased interest in alternatives. Peripheral regional anaesthesia techniques have become more popular as a component of multimodal analgesia to avoid complications associated with epidural analgesia. In 2016, ESP block, which is an ultrasound-controlled fascial plane block, was described. ESP block is considered to be an easier, effective and safer alternative to epidural and paravertebral blocks. The mechanism of action of ESP involves blockade of both dorsal and ventral branches, resulting in somatic and visceral analgesia. Intraoperative and postoperative renal function may be impaired in upper abdominal surgeries. Acute kidney injury (AKI) is an important cause of postoperative mortality and morbidity. The most serious adverse factor is both surgical and anaesthesia-related AKI. hypotension that may develop. The duties of the anaesthesiologist include maintaining perioperative renal function, predetermining the risk of AKI and taking necessary precautions. Considering the data in the literature, postoperative AKI Recent studies have shown that there is a link between inflammation and cancer. Studies reveal a relationship between cytokine and chemokine production and tumour growth, angiogenesis and metastatic capacity. Inflammatory cells and substances produced by inflammation affect cells in the peripheral blood. Platelets promote extravasation of circulating tumour cells. Neutrophils can also promote tumour adhesion and seeding by secreting growth factors into the peripheral circulation. However, lymphocytes can exert anti-tumour effects by inhibiting the proliferation and migration of tumour cells. From this point of view, SII (Systemic inflammation index) is a new prognostic factor obtained by measuring the number and ratio of neutrophils, platelets and lymphocytes in the peripheral blood of many tumours. In this study, the effects of epidural analgesia and ESP block on intraoperative opioid requirement and postoperative pain scores, as well as perioperative renal parameters, haemodynamic data and SII (Systemic inflammation index) were investigated and the alternative of ESP block to epidural analgesia was investigated.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-12-19 | N/A | 2024-02-16 |
2024-02-03 | N/A | 2024-02-20 |
2024-02-12 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Epidural analgesia The patients were fasted for 8 hours before the operation without premedication. The patient was taken to the operation room. In all cases, a vein on the back of the hand was cannulated for peripheral venous catheter was cannulated from the back of the ha | |
| : Erector Spina Plan(ESP) Block Esp group included 28 patients in the preoperative operating theatre between T8 and T10 1 hour before the operation. level, the USG (ultrasonography) probe is placed in the midline in the cephalocaudal direction and then the USG (ultrasonography) probe i |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Intraoperative remifentayl consumption (microgram) | Total amount of remifentanyl during the Intraoperative period | peroperatively |
| Postoperative visual analog scale(1-10) | the investigators aimed to compare postoperative visual analog scale of two groups.The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain 10 indicates severe pain | at the postoperative 1. hour |
| Rate of heart beat (beat/min) | the investigators aimed to compare intraoperative pulse rate of two groups | During the anesthesia, It will be evaluated at 1 hour intervals. |
| Value of systolic blood pressure (mmHg) | the investigators aimed to compare intraoperative systolic blood pressure of two groups | During the anesthesia, It will be evaluated at 1 hour intervals. |
| Rate of systemic inflammation index: SII (Systemic immune inflammatory index) is the formulation of the values of platelets, neutrophils and lymphocytes in peripheral blood as P X N / L = SII. | the investigators aimed to compare postoperative systemic inflammation index of two groups. | At the preoperative and postoperative time points |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Amount of postoperative creatinine (mg/dl) | the investigators aimed to compare postoperative creatine of two groups | At the postoperative 24.hour |
| Amount of postoperative urea (mg/L) | It will be aimed to compare postoperative urea of two groups | at the postoperative 24.hour |
| incidence of death (percentage of ) | the investigators aimed to compare postoperative mortality of two groups | at postoperative 1.year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
