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Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Cardiac Surgery

ConditionsCardiac SurgeryPostoperative PainPostoperative Recovery After Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBurak Çilingir

About this trial

This prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. A total of 50 adult patients will be randomized into two groups: an SPSIP block group and a control group. The investigators will assess postoperative pain, opioid consumption, and quality of recovery during the postoperative period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-80 years

Patients scheduled for elective cardiac surgery

American Society of Anesthesiologists (ASA) physical status III--IV

Patients who provide written informed consent to participate in the study

Disqualifiers

Patient refusal to participate in the study

Known allergy to local anesthetics

Infection at the site of block application

Coagulopathy or contraindication to regional anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serratus posterior superior intercostal plane block

    Procedure/Surgery

    After induction of general anesthesia, an ultrasound-guided bilateral serratus posterior superior intercostal plane (SPSIP) block will be performed at the level of the third rib. Under ultrasound guidance, the needle will be advanced to the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After confirmation of appropriate needle-tip position, 20 mL of 0.25% bupivacaine will be administered on each side. The same procedure will then be performed on the contralateral side.

  • Standard Perioperative Care

    Procedure/Surgery

    Participants in the control group will receive standard perioperative care without serratus posterior superior intercostal plane (SPSIP) block. The perioperative management and postoperative follow-up protocol will otherwise be the same as in the SPSIP block group.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: SPSIP Block GroupActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Quality of Recovery Assessed by QoR-15T

Postoperative quality of recovery will be assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T). The QoR-15T consists of 15 items assessing multiple dimensions of postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.

Time frame
Postoperative 24 hours

Secondary outcomes

1

Total Postoperative Tramadol Consumption

Total postoperative tramadol consumption will be recorded as the cumulative amount of tramadol administered during the first 48 hours after surgery. Tramadol consumption will be reported in milligrams (mg).

Time frame
From the end of surgery to postoperative 48 hours
2

Postoperative Pain Intensity

Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be recorded at postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours.

Time frame
Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours
3

Number of Participants With Postoperative Nausea and/or Vomiting (PONV)

The occurrence of postoperative nausea and/or vomiting (PONV) will be assessed at postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours. At each predefined time point, the presence or absence of nausea and/or vomiting will be recorded as a binary outcome (yes/no). The number of participants experiencing nausea and/or vomiting will be recorded and compared between the groups.

Time frame
Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours
4

Intensive Care Unit Length of Stay

The duration of the first postoperative intensive care unit (ICU) stay will be recorded for each participant. ICU length of stay will be calculated from postoperative admission to the ICU until the first discharge from the ICU and will be reported in hours.

Time frame
From postoperative ICU admission until first ICU discharge, an average of 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Burak Çilingir

Lead sponsor

Adiyaman University Research Hospital

Sponsor institution

Source ClinicalTrials.gov

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