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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04924335
Enrollment
70
Registered
2021-06-14
Start date
2021-03-01
Completion date
2021-08-01
Last updated
2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery Stress

Keywords

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

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.

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.

Interventions

PROCEDUREErector spinae plane block

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fifth measurements- end of surgeryAt the end of surgery, an average of 20 minutesAt the end of surgery, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Basal measurements- after anesthesia inductionAfter anesthesia induction, an average of 5 minutesAfter induction of anesthesia, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Second measurements- after cardiopulmonary bypass initiationAfter cardiopulmonary bypass inititation, an average of 5 minutesAfter cardiopulmonary bypass initiation, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Third measurements- during cardiopulmonary bypass, at lowest temperatureDuring cardiopulmonary bypass, an average of 10 minutesDuring cardiopulmonary bypass, at lowest temperature, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.
Fourth measurements- end of cardiopulmonary bypassAt the end of cardiopulmonary bypass, an average of 10 minutesAt the end of cardiopulmonary bypass, blood gas analysis will be performed and lactate level (mmol/L) will be recorded.

Secondary

MeasureTime frameDescription
Preoperative complete blood countThe day before surgery, 24 hoursPreoperative complete blood count will be evaluated and recorded.
Preoperative albuminThe day before surgery, 24 hoursPreoperative albumin levels will be evaluated and recorded.
Postoperative C reactive protein6 hours after surgeryPostoperative C reactive protein levels will be evaluated and recorded.
Postoperative complete blood count6 hours after surgeryPostoperative complete blood count will be evaluated and recorded.
Postoperative albumin6 hours after surgeryPostoperative albumin levels will be evaluated and recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026