Effects of Erector Spina Plan Block and Epidural Analgesia in Whipple Surgery

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT06254430
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-03-20
• Primary Completion: 2023-07-20
• Study Completion: 2023-07-30
• Study First Submitted: 2023-12-19
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-03
• Study First Posted: 2024-02-12
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Patients undergoing whipple surgery,
• ASA (The American Society of Anesthesiologists) I-III risk grup
• Between the ages of 18-80

Exclusion Criteria

• Those who do not accept the transaction,
• Serious cardiovascular disease,
• Those for whom epidural anesthesia and peripheral blocks are contraindicated,
• Those who have had spinal surgery,
• Those who are allergic to one of the local anesthetics to be used,
• Those whose hemoglobin value is below 10 g/dl) disease,
• Those with drug and alcohol addiction,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative visual analog scale(1-10)	at the postoperative 1. hour	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
Intraoperative remifentayl consumption (microgram)	peroperatively	Total amount of remifentanyl during the Intraoperative period
Rate of heart beat (beat/min)	During the anesthesia, It will be evaluated at 1 hour intervals.	the investigators aimed to compare intraoperative pulse rate of two groups
Value of systolic blood pressure (mmHg)	During the anesthesia, It will be evaluated at 1 hour intervals.	the investigators aimed to compare intraoperative systolic blood pressure of two groups
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.	At the preoperative and postoperative time points	the investigators aimed to compare postoperative systemic inflammation index of two groups.

Secondary Outcome Measures

Name	Time	Method
Amount of postoperative creatinine (mg/dl)	At the postoperative 24.hour	the investigators aimed to compare postoperative creatine of two groups
Amount of postoperative urea (mg/L)	at the postoperative 24.hour	It will be aimed to compare postoperative urea of two groups
incidence of death (percentage of )	at postoperative 1.year	the investigators aimed to compare postoperative mortality of two groups

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Çankaya, Turkey