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

NCT04924335 | Completed DMC

• 1 other identifier: MH2.2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery Stress

Keywords

erector spinae plane block; cardiac surgery; enhanced recovery after surgery program; lactate; stress response; c reactive protein

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (5)

• Preoperative complete blood count

  The day before surgery, 24 hours

• Preoperative albumin

  The day before surgery, 24 hours

• Postoperative C reactive protein

  6 hours after surgery

• Postoperative complete blood count

  6 hours after surgery

• Postoperative albumin

  6 hours after surgery

Study Arms (2)

ESP group

ACTIVE COMPARATOR

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

Conventional group

NO INTERVENTION

The conventional group will receive ERAS cardiac anesthesia protocol

Interventions

Erector spinae plane block PROCEDURE

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

ESP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Select State/Province, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Serdar Günaydın, Professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 14, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

TU (1)