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

NCT06254430 | Completed

• 1 other identifier: E2-22-1596
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Amount of postoperative creatinine (mg/dl)

  At the postoperative 24.hour

• Amount of postoperative urea (mg/L)

  at the postoperative 24.hour

• incidence of death (percentage of )

  at postoperative 1.year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 35907711 BACKGROUND

• 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.

  PMID: 37038338 BACKGROUND

• 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.

  PMID: 35566705 BACKGROUND

• 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.

  PMID: 35454326 BACKGROUND

• 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.

  PMID: 37470522 BACKGROUND

• 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.

  PMID: 33468017 BACKGROUND

• 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.

  PMID: 37284203 BACKGROUND

• 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.

  PMID: 36820108 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: February 12, 2024
• Study Start: March 20, 2023
• Primary Completion: July 20, 2023
• Study Completion: July 30, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)