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Comparison of IV Analgesia, Thoracic Epidural Analgesia, and ESP Block for Chronic Pain After Open Heart Surgery

ConditionsChronic Postoperative PainOpen Heart SurgeryPostoperative AnalgesiaAnalgesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorKaradeniz Technical University

About this trial

This prospective observational study aims to compare three routinely used postoperative analgesia techniques in patients undergoing open heart surgery: intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB). The primary objective is to evaluate the impact of these analgesia modalities on the development of chronic postoperative pain at 3 months. Secondary objectives include assessing postoperative acute pain scores, additional analgesic requirements, extubation time, mobilization time, intensive care unit stay, hospital stay, respiratory complications, and the relationship between acute and chronic pain. No intervention is assigned by protocol, and all analgesia methods are applied as part of routine clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 85 years

Classified as ASA physical status I-III

Scheduled to undergo open heart surgery with median sternotomy

BMI < 35 kg/m²

Disqualifiers

Age < 18 or > 85 years

BMI ≥ 35 kg/m²

Coagulation disorders

Infection at the intervention site

Trial population

Adult patients aged 18 to 85 years who are scheduled to undergo open heart surgery with median sternotomy at Karadeniz Technical University Farabi Hospital. All participants will receive one of the routinely used postoperative analgesia methods (intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block) as determined by the clinical anesthesia team. Only patients classified as ASA physical status I-III and able to provide informed consent are included. Individuals with major comorbidities that interfere with participation, prior cardiac surgery, chronic pain treatment, or contraindications to routine analgesia methods are excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intravenous Analgesia

    Other intervention

    Routine postoperative intravenous analgesia (opioid and/or non-opioid medications) administered according to standard clinical care. This is not assigned by protocol and represents usual practice.

  • Thoracic Epidural Analgesia (TEA)

    Other intervention

    Thoracic epidural catheterization performed as part of routine postoperative analgesia management. This practice is determined by the clinical anesthesia team and not assigned by the study protocol.

  • Erector Spinae Plane Block (ESPB)

    Other intervention

    Bilateral erector spinae plane block performed preoperatively as part of routine perioperative analgesia. The technique is applied at the discretion of the clinical anesthesia team and is not protocol-assigned.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Intravenous Analgesia Group (IV)3 interventions
Group B: Thoracic Epidural Analgesia Group (TEA)3 interventions
Group C: Erector Spinae Plane Block Group (ESPB)3 interventions

Trial outcomes

Primary outcomes

1

Chronic Postoperative Pain at 3 Months

Chronic postoperative pain will be assessed 3 months after surgery using the Numeric Rating Scale (NRS, 0-10) and the S-LANSS questionnaire. Participants will be contacted via telephone or in-person follow-up. Chronic pain is defined as pain persisting beyond the expected healing period and lasting at least 3 months.

Time frame
3 Months Postoperative

Secondary outcomes

1

Acute Postoperative Pain Scores

Pain intensity will be measured using the Numeric Rating Scale (NRS, 0-10) at routine postoperative intervals in the ICU and ward.

Time frame
0-72 hours postoperative
2

Additional Analgesic Consumption

Total amount and frequency of rescue analgesic medications administered during the postoperative hospital period.

Time frame
0-72 hours postoperative
3

Extubation Time

Time from ICU admission after surgery to successful extubation, recorded from anesthesia and ICU charts.

Time frame
Up to 72 hours postoperative
4

Mobilization Time

Time to first mobilization (sitting, standing, or ambulation) recorded by ICU or ward nursing staff.

Time frame
Postoperative day 0-2

Other outcomes

Sponsors and contacts

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Karadeniz Technical University

Lead sponsor

Source ClinicalTrials.gov
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