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

Surgery Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924335
• Other study ID #: MH2.2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Intervention

Procedure:
• Erector spinae plane block
Preoperative ultrasound-guided bilateral erector spinae plane block with 20 ml 0.025% bupivacaine.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara	Select State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Preoperative complete blood count	Preoperative complete blood count will be evaluated and recorded.	The day before surgery, 24 hours
Secondary	Preoperative albumin	Preoperative albumin levels will be evaluated and recorded.	The day before surgery, 24 hours
Secondary	Postoperative C reactive protein	Postoperative C reactive protein levels will be evaluated and recorded.	6 hours after surgery
Secondary	Postoperative complete blood count	Postoperative complete blood count will be evaluated and recorded.	6 hours after surgery
Secondary	Postoperative albumin	Postoperative albumin levels will be evaluated and recorded.	6 hours after surgery