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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06100
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who will have whipple surgery operation under general anesthesia in Ankara Bilkent City Hospital Operating Room,between the ages of 18-80,both genders and in the ASA (The American Society of Anesthesiologists) 1,2,3 risk grup will be included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 hand. Standard monitoring was applied. In the epidural group, 42 patients received a standard 18 G injection at the appropriate level between T8 and T10. The epidural space was entered by loss of resistance method with touchy needle. 15 µg in 3 mL saline The test dose was administered by administering epinephrine. Then the epidural catheter was inserted towards the cranium. was advanced five cm. Bupivacaine 0.25% was started as infusion through the catheter. Since the mean arterial pressure dropped below 60 mm/hg in 5 patients, epidural infusion was stopped and inotropic treatment was started.
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 is placed approximately 3 cm laterally over the transverse processes and transverse with the erector spinae muscle 0.25 % bupivacaine 20 cc each in the fascial plane between the processes bilateral thoracic erector spina block and then 50 mg dexketoprofen before surgery implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Viderman D, Tapinova K, Nabidollayeva F, Tankacheev R, Abdildin YG. Intravenous versus Epidural Routes of Patient-Controlled Analgesia in Abdominal Surgery: Systematic Review with Meta-Analysis. J Clin Med. 2022 May 5;11(9):2579. doi: 10.3390/jcm11092579.
• Walter CM, Lee CS, Moore DL, Abbasian N, Clay SJ, Mecoli MD, Olbrecht VA, Batra M, Ding L, Yang F, Nair M, Huq A, Simpson BE, Brown RL, Garcia VF, Chidambaran V. Retrospective study comparing outcomes of multimodal epidural and erector spinae catheter pain protocols after pectus surgery. J Pediatr Surg. 2023 Mar;58(3):397-404. doi: 10.1016/j.jpedsurg.2022.06.017. Epub 2022 Jul 6.
• Putowski Z, Majewska K, Gruca K, Zimnoch A, Szczepanska A, Krzych LJ, Jablonska B, Mrowiec S. Intraoperative Hypotension and Its Association with Postoperative Acute Kidney Injury in Patients Undergoing Pancreaticoduodenectomy: A 5-Year, Single-Center, Retrospective Cohort Study. Med Sci Monit. 2023 Apr 11;29:e938945. doi: 10.12659/MSM.938945.
• Jipa M, Isac S, Klimko A, Simion-Cotorogea M, Martac C, Cobilinschi C, Droc G. Opioid-Sparing Analgesia Impacts the Perioperative Anesthetic Management in Major Abdominal Surgery. Medicina (Kaunas). 2022 Mar 28;58(4):487. doi: 10.3390/medicina58040487.
• Nair A, Saxena P, Borkar N, Rangaiah M, Arora N, Mohanty PK. Erector spinae plane block for postoperative analgesia in cardiac surgeries- A systematic review and meta-analysis. Ann Card Anaesth. 2023 Jul-Sep;26(3):247-259. doi: 10.4103/aca.aca_148_22.
• Zhang Y, Chong JH, Harky A. Enhanced recovery after cardiac surgery and its impact on outcomes: A systematic review. Perfusion. 2022 Mar;37(2):162-174. doi: 10.1177/0267659121988957. Epub 2021 Jan 19.
• Chen Q, Ren S, Cui S, Huang J, Wang D, Li B, He Q, Lang R. Prognostic and recurrent significance of SII in patients with pancreatic head cancer undergoing pancreaticoduodenectomy. Front Oncol. 2023 May 22;13:1122811. doi: 10.3389/fonc.2023.1122811. eCollection 2023.
• Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Tulgar S, Ultan Ozgen G. Can Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, or Systemic Immune Inflammation Index Be an Indicator of Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy? Cureus. 2023 Jan 19;15(1):e33955. doi: 10.7759/cureus.33955. eCollection 2023 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: E2-22-1596

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No