Bursa City Hospital
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07394673
This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bursa, 16110, Turkey (Türkiye)
Location status: Recruiting
Most patients undergoing arthroscopic shoulder surgery report pain in the postoperative period. Pain management remains a significant concern in patient management, as it affects surgical costs, postoperative mobility, length of hospital stay, patient satisfaction, and surgical outcomes. Multimodal analgesia is recommended for the management of postoperative pain. Regional analgesia is an important component of multimodal analgesia.
The serratus posterior superior intercostal plane (SPSIP) block is a novel regional analgesia technique described in 2023. SPSIP has been reported to provide near-complete sensory blockade in the posterior neck, shoulder, and hemithorax regions.
The main objective of this study is to investigate the effectiveness of SPSIP block in patients undergoing arthroscopic shoulder surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Serratus Posterior Superior İntercostal Plane (SPSIP) Block will be performed before the surgery in seated position, under standard sterilization conditions.A linear ultrasound probe will be placed in the sagittal plane along the medial border of the scapula, and the second and third ribs, relevant muscles, and the pleura will be identified.
The needle will be advanced into the interfascial plane between the serratus posterior superior and intercostal muscles. After confirmation with salin injection , the block will be performed by injecting 30 mL of 0.25% bupivacaine, and the cranio-caudal spread will be visualized under ultrasound.
Time frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams(mg)
Time frame: Postoperative 24th and 48th hours
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre
PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent])
Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being
PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
Time frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
Numeric Rating Scale (NRS) (0-10 0: No pain 10: most pain felt) pain scores at rest or movement at predefined postoperative hours
Time frame: Postoperative 24th and 48th hours
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as
Time frame: Postoperative 48-Hours
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered. The time will be recorded.
Time frame: the day of surgery, the day of discharge from the hospital
Number of days spent in hospital after surgery
Time frame: Postoperative 48-Hours
Block- and opioid-related adverse effects and complications, including but not limited to local anesthetic toxicity, hematoma, infection, nerve injury, nausea, vomiting, pruritus, sedation, and respiratory depression, will be recorded
Time frame: Start time: Start of anesthesia administration End time: Termination of anesthesia administration
The amount of remifentanil administered in micrograms during general anesthesia
Contact information is provided by the study sponsor or research team.
Merih Yıldız Eglen, MD
CONTACT
Mursel Ekinci, Assoc prof, MD
CONTACT
Bursa City Hospital
Other Gov
Postoperative Analgesic Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
Acronym: SPSIP
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.
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