Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries

Study Overview
=================
Brief Summary
-----------------
Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy

Detailed Description
-----------------
Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours. Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia. The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day. All patients underwent general anesthesia with the same method and medications. Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.

Official Title
-----------------
Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''

Conditions
-----------------
Pain, Postoperative, Respiratory Complication

Intervention / Treatment
-----------------
* Procedure: Thoracic epidural analgesia
* Procedure: Erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has ASA II-IV score Having open heart surgery Exclusion Criteria: Having a psychiatric illness Using analgesic medication due to chronic pain Uncooperative

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracic epidural analgesia<br>Thoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours | Procedure: Thoracic epidural analgesia<br>* Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours<br>|
| Active Comparator: Erector spinae plane block<br>Erector spinae plane blockwas applied preoperatively | Procedure: Erector spinae plane block<br>* Erector spinae plane block was applied preoperatively using local anesthetic<br>|
| No Intervention: Intravenous opioid analgesia<br>Intravenous opioid analgesia was administered during the surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale). Pain levels were evaluated between 0 and 10 points. 0: No pain (the best)….. 10: Unbearable pain (the worst) | Postoperative 48 hours | 
| Respiratory functions | Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement. Tachypnea:more than 20/min Fever: more than 37 C celcius Non invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask) | Postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic requirement. When the VRS was more than 4 points | diclofenac (75 mg), tramadol (50mg) | Postoperative 48 hours | 
| Intensive care and hospital stay | time for Intensive care and hospital (hours and days, respectively) | postoperative 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic epidural analgesia, erector spinae plane block, heart surgery