Clinical trial NCT04924335: The Effects of Erector Spinae Plane (ESP) Block on Surgery-related Stress Response in Cardiac Surgery With ERAS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery Stress
Keywords: erector spinae plane block
cardiac surgery
enhanced recovery after surgery program
lactate
stress response
c reactive protein
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Basal measurements- after anesthesia induction
timeFrame: After anesthesia induction, an average of 5 minutes
measure: Basal measurements- after anesthesia induction
timeFrame: After anesthesia induction, an average of 5 minutes
measure: Second measurements- after cardiopulmonary bypass initiation
timeFrame: After cardiopulmonary bypass inititation, an average of 5 minutes
measure: Second measurements- after cardiopulmonary bypass initiation
timeFrame: After cardiopulmonary bypass inititation, an average of 5 minutes
measure: Third measurements- during cardiopulmonary bypass, at lowest temperature
timeFrame: During cardiopulmonary bypass, an average of 10 minutes
measure: Third measurements- during cardiopulmonary bypass, at lowest temperature
timeFrame: During cardiopulmonary bypass, an average of 10 minutes
measure: Fourth measurements- end of cardiopulmonary bypass
timeFrame: At the end of cardiopulmonary bypass, an average of 10 minutes
measure: Fourth measurements- end of cardiopulmonary bypass
timeFrame: At the end of cardiopulmonary bypass, an average of 10 minutes
measure: Fifth measurements- end of surgery
timeFrame: At the end of surgery, an average of 20 minutes
measure: Fifth measurements- end of surgery
timeFrame: At the end of surgery, an average of 20 minutes
Secondary outcomes:
measure: Preoperative complete blood count
timeFrame: The day before surgery, 24 hours
measure: Preoperative albumin
timeFrame: The day before surgery, 24 hours
measure: Postoperative C reactive protein
timeFrame: 6 hours after surgery
measure: Postoperative complete blood count
timeFrame: 6 hours after surgery
measure: Postoperative albumin
timeFrame: 6 hours after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Select State/Province
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Serdar Günaydın, Professor
role: PRINCIPAL_INVESTIGATOR
References: