The Effects of Erector Spinae Plane (ESP) Block on Surgery-related Stress Response in Cardiac Surgery With ERAS

Ultrasound-guided Erector Spinae Plane (ESP) Block Attenuates Surgery-related Stress Response in Cardiac Surgery Patients Undergoing Enhanced Recovery After Surgery (ERAS) Program

Surgery-induced pain reveals its own metabolic and inflammatory responses, resulting in a further increase in noxious pathways that are already occurring. Even though it is difficult to distinguish whether the metabolic and inflammatory responses are pain-induced or surgical-induced, it is clear that pain can cause a response. This study aims to investigate the effects of erector spinae plane block on surgery-related stress response with enhanced recovery after cardiac surgery protocol.

Study Overview

• Status: Completed
• Conditions: Surgery Stress
• Intervention / Treatment: Procedure: Erector spinae plane block

Detailed Description

The Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) program includes a perioperative multimodal, opioid-sparing pain management plan as an essential component of any comprehensive program. A multimodal pain management plan is nonopioid systemic analgesic agents, regional and local anesthetic techniques, and judicious use of opioids. This study aims to examine inflammatory and hematological parameters in patients who underwent cardiac surgery with ERAS, with and without preoperative bilateral erector spinae plane block (ESP). For this purpose, the presence of an obstacle ESP block application in the preoperative period will be investigated in patients who are prepared for cardiac surgery according to ERAS principles, and the patient's group will be determined accordingly. An analgesia protocol that does not include a regional technique will be applied to the patient in cases such as the patient's refusal to allow preoperative block and the presence of a situation that does not allow blockage in the block area. The perioperative characteristics of ERAS patients with and without ESP block will be examined, intraoperative lactate, and preop-postoperative hemogram-albumin-C reactive protein parameters will be recorded.

ERAS patients with ESP block: After preparation in accordance with the ERAS protocol, ultrasound-guided bilateral ESP block will be performed with 20 ml of 0.025% bupivacaine at T5-7 levels in patients taken to the operating room in the preoperative period, and will be administered intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.

ERAS patients without ESP block: After preparation according to the ERAS protocol, patients will be administered lidocaine, ketamine, paracetamol, and intraoperative low-dose remifentanil infusion and sevoflurane anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Select State/Province
    • Ankara, Select State/Province, Turkey, 06800
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients who will undergo open-heart surgery with ERAS protocol

Exclusion Criteria:

• Emergency surgeries
• Patients with allergic reactions to anesthesia and analgesia drugs to be used
• Patients who do not want to participate in the study voluntarily
• Severe systemic disease (kidney, liver, pulmonary, endocrine)
• Substance abuse history
• History of chronic pain
• Psychiatric problems and communication difficulties
• Patients who need revision due to hemostasis in the postoperative period
• Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ESP group; ESP group patients will be performed ultrasound-guided erector spinae plane block with 20 ml 0.025% Bupivacaine, preoperatively and will receive ERAS cardiac anesthesia protocol	Procedure: Erector spinae plane block; Preoperative ultrasound-guided bilateral erector spinae plane block with 20 ml 0.025% bupivacaine.
NO_INTERVENTION: Conventional group; The conventional group will receive ERAS cardiac anesthesia protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal measurements- after anesthesia induction	After induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.	After anesthesia induction, an average of 5 minutes
Basal measurements- after anesthesia induction	After induction of anesthesia, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.	After anesthesia induction, an average of 5 minutes
Second measurements- after cardiopulmonary bypass initiation	After cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.	After cardiopulmonary bypass inititation, an average of 5 minutes
Second measurements- after cardiopulmonary bypass initiation	After cardiopulmonary bypass initiation, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.	After cardiopulmonary bypass inititation, an average of 5 minutes
Third measurements- during cardiopulmonary bypass, at lowest temperature	During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.	During cardiopulmonary bypass, an average of 10 minutes
Third measurements- during cardiopulmonary bypass, at lowest temperature	During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.	During cardiopulmonary bypass, an average of 10 minutes
Fourth measurements- end of cardiopulmonary bypass	At the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.	At the end of cardiopulmonary bypass, an average of 10 minutes
Fourth measurements- end of cardiopulmonary bypass	At the end of cardiopulmonary bypass, blood gas analysis will be performed and hemoglobin level (g(dL) will be recorded.	At the end of cardiopulmonary bypass, an average of 10 minutes
Fifth measurements- end of surgery	At the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.	At the end of surgery, an average of 20 minutes
Fifth measurements- end of surgery	At the end of surgery, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.	At the end of surgery, an average of 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative complete blood count	Preoperative complete blood count will be evaluated and recorded.	The day before surgery, 24 hours
Preoperative albumin	Preoperative albumin levels will be evaluated and recorded.	The day before surgery, 24 hours
Postoperative C reactive protein	Postoperative C reactive protein levels will be evaluated and recorded.	6 hours after surgery
Postoperative complete blood count	Postoperative complete blood count will be evaluated and recorded.	6 hours after surgery
Postoperative albumin	Postoperative albumin levels will be evaluated and recorded.	6 hours after surgery

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Serdar Günaydın, Professor, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: May 22, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (ACTUAL): June 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; stress response; c reactive protein; lactate; erector spinae plane block; enhanced recovery after surgery program
• Other Study ID Numbers: MH2.2

Drug and device information, study documents

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