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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06098859
Enrollment
93
Registered
2023-10-25
Start date
2023-01-10
Completion date
2023-09-15
Last updated
2023-10-25

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

Conditions

Pain, Postoperative, Respiratory Complication

Keywords

Thoracic epidural analgesia, erector spinae plane block, heart surgery

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.

Interventions

PROCEDUREThoracic epidural analgesia

Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

PROCEDUREErector spinae plane block

Erector spinae plane block was applied preoperatively using local anesthetic

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants did not know which method was applied to them. Those who evaluated the research results did not know the groups

Intervention model description

The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painPostoperative 48 hoursPatients 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)
Respiratory functionsPostoperative 48 hoursOxygen 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)

Secondary

MeasureTime frameDescription
Analgesic requirement. When the VRS was more than 4 pointsPostoperative 48 hoursdiclofenac (75 mg), tramadol (50mg)
Intensive care and hospital staypostoperative 30 daystime for Intensive care and hospital (hours and days, respectively)

Countries

Turkey (Türkiye)

Outcome results

None listed

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