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Serratus Posterior Superior Plane Block for Postoperative Pain in Cardiac Surgery

ConditionsCardiac SurgeryPost Operative Pain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOndokuz Mayıs University

About this trial

The aim of this study is to investigate the efficacy of bilateral serratus posterior superior intercostal plane (SPSIP) block on postoperative acute pain and opioid consumption in patients undergoing on-pump open-heart surgery. Postoperative outcomes including pain scores, cumulative morphine use, quality of recovery, and opioid-related side effects will be evaluated within the first 24 hours after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy.

American Society of Anesthesiologists (ASA) classification II-III patients.

Patients who can use PCA.

Patients who will sign the informed consent form.

Disqualifiers

History of opioid use for more than four weeks

Chronic pain syndromes

Patients with a history of local anesthetic or opioid allergy, hypersensitivity

Alcohol and drug addiction

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bilateral ultrasound guided Serratus Posterior Superior Plane Block

    Procedure/Surgery

    Bilateral ultrasound-guided Serratus Posterior Superior Plane Block (total of 60 ml, %0.25 bupivacaine) will be performed Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis.

  • IV morphine patient-controlled analgesia

    Drug

    IV PCA of 0,5mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).

  • Bilateral ultrasound guided Sham Block

    Procedure/Surgery

    Bilateral ultrasound-guided needle placement will be performed in the same anatomical plane as in the SPSIP group, but instead of local anesthetic, an equivalent volume of normal saline (30 mL per side) will be injected. Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group SPSIPActive comparator 2 interventions
Group B: Group ControlSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Cumulative opioid consumption in the first 24 hours after surgery

The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA- administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.

Time frame
Postoperative day 1

Secondary outcomes

1

Cumulative opioid consumption in the first 12 hours after surgery

The secondary outcome will be defined as cumulative opioid consumption during the first 12 hours following surgery, calculated in intravenous morphine milligram equivalents (IV-MME). This will include both PCA-administered morphine and rescue intravenous tramadol, in accordance with the standardized ESAIC conversion guidelines. Patients may request opioids using a PCA device when their NRS score is ≥ 4.

Time frame
Postoperative12 hours
2

Numerical Rating Scale Assessment of Postoperative Pain

Pain scores will be assessed using the 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 represents the worst imaginable pain. Evaluations will be performed both at rest (static) and during coughing or deep breathing (dynamic). Assessments will be conducted in the post-anesthesia care unit (PACU) after extubation and once communication is established, and subsequently at 3, 6, 12, 18, and 24 hours postoperatively.

Time frame
Postoperative day 1
3

Intraoperative Remifentanil Consumption

Total intraoperative remifentanil consumption will be recorded in micrograms (μg) from the start of anesthesia induction until the end of surgery.

Time frame
The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 250 minutes
4

Time to First Opioid Demand via PCA

Defined as the time elapsed from the patient's arrival in the post-anesthesia care unit (PACU) to the first patient- initiated opioid request via the patient-controlled analgesia (PCA) device.

Time frame
Postoperative day 1

Other outcomes

Sponsors and contacts

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Ondokuz Mayıs University

Lead sponsor

Source ClinicalTrials.gov
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