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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Respiratory Complication
• Interventions: Procedure: Thoracic epidural analgesia; Procedure: Erector spinae plane block

• Registration Number: NCT06098859
• Lead Sponsor: Karadeniz Technical University

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.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2023-08-28
• Study Completion: 2023-09-15
• Status Verified: 2023-10
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic epidural analgesia	Thoracic epidural analgesia	Thoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours
Erector spinae plane block	Erector spinae plane block	Erector spinae plane blockwas applied preoperatively

Primary Outcome Measures

Name	Time	Method
Respiratory functions	Postoperative 48 hours	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 pain	Postoperative 48 hours	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Engin Ertürk; 🇹🇷 Ortahisar, Trabzon, Turkey