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Completed

NCT Number: NCT04924335

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erector Spinae Plane Block

Procedure

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

Primary outcomes

  1. Basal measurements- after anesthesia induction

    Time frame: After anesthesia induction, an average of 5 minutes

    After induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.

  2. Basal measurements- after anesthesia induction

    Time frame: After anesthesia induction, an average of 5 minutes

    After induction of anesthesia, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.

  3. Second measurements- after cardiopulmonary bypass initiation

    Time frame: After cardiopulmonary bypass inititation, an average of 5 minutes

    After cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.

  4. Second measurements- after cardiopulmonary bypass initiation

    Time frame: After cardiopulmonary bypass inititation, an average of 5 minutes

    After cardiopulmonary bypass initiation, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.

  5. Third measurements- during cardiopulmonary bypass, at lowest temperature

    Time frame: During cardiopulmonary bypass, an average of 10 minutes

    During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.

  6. Third measurements- during cardiopulmonary bypass, at lowest temperature

    Time frame: During cardiopulmonary bypass, an average of 10 minutes

    During cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.

  7. Fourth measurements- end of cardiopulmonary bypass

    Time frame: At the end of cardiopulmonary bypass, an average of 10 minutes

    At the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.

  8. Fourth measurements- end of cardiopulmonary bypass

    Time frame: At the end of cardiopulmonary bypass, an average of 10 minutes

    At the end of cardiopulmonary bypass, blood gas analysis will be performed and hemoglobin level (g(dL) will be recorded.

  9. Fifth measurements- end of surgery

    Time frame: At the end of surgery, an average of 20 minutes

    At the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.

  10. Fifth measurements- end of surgery

    Time frame: At the end of surgery, an average of 20 minutes

    At the end of surgery, blood gas analysis will be performed and hemoglobin level (g/dL) will be recorded.

Secondary outcomes

  1. Preoperative complete blood count

    Time frame: The day before surgery, 24 hours

    Preoperative complete blood count will be evaluated and recorded.

  2. Preoperative albumin

    Time frame: The day before surgery, 24 hours

    Preoperative albumin levels will be evaluated and recorded.

  3. Postoperative C reactive protein

    Time frame: 6 hours after surgery

    Postoperative C reactive protein levels will be evaluated and recorded.

  4. Postoperative complete blood count

    Time frame: 6 hours after surgery

    Postoperative complete blood count will be evaluated and recorded.

  5. Postoperative albumin

    Time frame: 6 hours after surgery

    Postoperative albumin levels will be evaluated and recorded.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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