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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254430
• Other study ID #: E2-22-1596
• Status: Completed
• Start date: March 20, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 30, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Pancreatic Cancer

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative remifentayl consumption (microgram)	Total amount of remifentanyl during the Intraoperative period	peroperatively
Primary	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
Primary	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.
Primary	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.
Primary	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	Amount of postoperative creatinine (mg/dl)	the investigators aimed to compare postoperative creatine of two groups	At the postoperative 24.hour
Secondary	Amount of postoperative urea (mg/L)	It will be aimed to compare postoperative urea of two groups	at the postoperative 24.hour
Secondary	incidence of death (percentage of )	the investigators aimed to compare postoperative mortality of two groups	at postoperative 1.year