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Completed

NCT Number: NCT06098859

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

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Complication Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Engin Ertürk

Ortahisar, Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic epidural analgesia

Procedure

Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours

Erector Spinae Plane Block

Procedure

Erector spinae plane block was applied preoperatively using local anesthetic

Primary outcomes

  1. Postoperative pain

    Time frame: 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)

  2. Respiratory functions

    Time frame: 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)

Secondary outcomes

  1. Analgesic requirement. When the VRS was more than 4 points

    Time frame: Postoperative 48 hours

    diclofenac (75 mg), tramadol (50mg)

  2. Intensive care and hospital stay

    Time frame: postoperative 30 days

    time for Intensive care and hospital (hours and days, respectively)

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study 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''

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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