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

Pain, Postoperative Clinical Trial

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''

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098859
• Other study ID #: 2023/184
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: October 2023
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 15, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Respiratory Complication

Intervention

Procedure:
• Thoracic epidural analgesia
Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours
• Erector spinae plane block
Erector spinae plane block was applied preoperatively using local anesthetic

Locations

Country	Name	City	State
Turkey	Engin Ertürk	Ortahisar	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Analgesic requirement. When the VRS was more than 4 points	diclofenac (75 mg), tramadol (50mg)	Postoperative 48 hours
Secondary	Intensive care and hospital stay	time for Intensive care and hospital (hours and days, respectively)	postoperative 30 days