Cardiac Surgery, Postoperative Pain, Postoperative Recovery After Cardiac Surgery
Conditions
Keywords
Serratus Posterior Superior Intercostal Plane Block, SPSIP Block, Quality of Recovery, QoR-15, QoR-15T, Postoperative Analgesia
Brief summary
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.
Detailed description
This prospective, randomized, controlled study will include 50 adult patients undergoing elective cardiac surgery. Patients will be randomly allocated to either the SPSIP block group or the control group. In the block group, an ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block will be performed in addition to the standard perioperative analgesic management. Patients in the control group will receive standard perioperative analgesic management without the SPSIP block. Postoperative pain intensity will be evaluated using the Numerical Rating Scale (NRS). Postoperative opioid requirements will also be recorded. In addition, postoperative recovery will be assessed using the Quality of Recovery-15T (QoR-15T) questionnaire. Patients will be followed during the postoperative period, including assessments at predefined time points up to 48 hours after surgery. The primary objective of the study is to determine whether bilateral SPSIP block improves postoperative recovery and provides effective postoperative analgesia in patients undergoing cardiac surgery. Secondary evaluations will include postoperative pain scores and opioid consumption.
Interventions
PROCEDURESerratus posterior superior intercostal plane block
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.
PROCEDUREStandard Perioperative Care
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.
Sponsors
Burak Çilingir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Postoperative outcome assessments will be performed by an investigator who is blinded to group allocation. The anesthesiologist performing the SPSIP block will not be involved in postoperative outcome assessment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the SPSIP block group or the control group. Participants in the SPSIP block group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane block in addition to standard perioperative care, while participants in the control group will receive standard perioperative care without the block.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Emergency surgery * Patients unable to communicate adequately or complete the study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Quality of Recovery Assessed by QoR-15T | Postoperative 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Tramadol Consumption | From the end of surgery to postoperative 48 hours | 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). |
| Postoperative Pain Intensity | Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours | 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. |
| Number of Participants With Postoperative Nausea and/or Vomiting (PONV) | Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours | 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. |
| Intensive Care Unit Length of Stay | From postoperative ICU admission until first ICU discharge, an average of 7 days | 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. |
| Ward Length of Stay | From first ICU discharge until hospital discharge, an average of 14 days | The duration of postoperative ward stay will be recorded for each participant. Ward length of stay will be calculated from the first discharge from the intensive care unit to hospital discharge and will be reported in days. |
| Total Hospital Length of Stay | From the day of surgery until hospital discharge, an average of 14 days | The total length of hospital stay will be recorded for each participant. Hospital length of stay will be calculated from the day of surgery until hospital discharge and will be reported in days. |
| Total Duration of Surgery | Intraoperative period, from the start to the end of surgery | The total duration of surgery will be recorded for each participant. Surgical duration will be defined as the time from the start of surgery to the completion of surgery and will be reported in minutes. |
| Postoperative Extubation Time | From the end of surgery until extubation, an average of 24 hours | Postoperative extubation time will be defined as the time from the end of surgery to removal of the endotracheal tube and will be recorded in hours. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBURAK ÇİLİNGİR, Resident Physician
Outcome results
None listed