Adıyaman Training and Research Hospital
Adıyaman, 02100, Turkey (Türkiye)
NCT Number: NCT07785323
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Adıyaman, 02100, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: SPSIP Block
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Burak Çilingir
Other
The Effect of Ultrasound-Guided Bilateral Single-Shot Serratus Posterior Superior Intercostal Plane Block on Recovery After Cardiac Surgery
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.
Published trials that share one or more normalized conditions with this study.
NCT07780773
Cardiac Surgery, Chronic Postsurgical Pain
Samsun, Turkey (Türkiye)
View Trial DetailsNCT07771751
Agnosia, Cardiac Surgery
Istanbul, Sancaktepe, Turkey (Türkiye)
View Trial DetailsNCT07716943
Cardiac Surgery, Cardiopulmonary Bypass
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07498946
Cardiac Surgery, Neurologic Manifestations
Gaziantep, Sahinbey, Turkey (Türkiye)
View Trial Details