Bursa City Hospital
Bursa, Nilüfer, Turkey (Türkiye)
Location status: Recruiting
Location contact
Mürsel Ekinci, MD
CONTACT
Mürsel Ekinci, MD
PRINCIPAL_INVESTIGATOR
Onur Güneş, MD
CONTACT
Onur Güneş, MD
SUB_INVESTIGATOR
NCT Number: NCT07668648
Arthroscopic shoulder surgery is associated with moderate to severe postoperative pain that may delay recovery and rehabilitation. Interscalene brachial plexus block (ISB) is widely used for postoperative analgesia in shoulder surgery; however, it may be associated with complications such as phrenic nerve paralysis. The serratus posterior superior intercostal plane (SPSIP) block is a recently described fascial plane block that may provide effective analgesia while avoiding some of the limitations of ISB.
This prospective, randomized, double-blind controlled trial aims to compare the analgesic efficacy of ISB and SPSIP block in patients undergoing elective arthroscopic shoulder surgery under general anesthesia. The primary outcome is total postoperative opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, quality of recovery, time to first rescue analgesia, rescue analgesic requirements, intraoperative opioid consumption, sensory block distribution, motor block characteristics, and block-related complications.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Bursa, Nilüfer, Turkey (Türkiye)
Location status: Recruiting
Mürsel Ekinci, MD
CONTACT
Mürsel Ekinci, MD
PRINCIPAL_INVESTIGATOR
Onur Güneş, MD
CONTACT
Onur Güneş, MD
SUB_INVESTIGATOR
Postoperative pain following arthroscopic shoulder surgery can adversely affect patient comfort, early mobilization, rehabilitation, and overall recovery. Although the interscalene brachial plexus block is considered the reference regional anesthesia technique for shoulder surgery, its use may be limited by adverse effects such as hemidiaphragmatic paresis, phrenic nerve involvement, and upper extremity motor weakness.
The serratus posterior superior intercostal plane block is a novel ultrasound-guided fascial plane block targeting the posterior thoracic region. Preliminary evidence suggests that it may provide analgesia extending to the shoulder area through spread to cervical and upper thoracic dermatomes. However, comparative clinical evidence between SPSIP block and ISB for arthroscopic shoulder surgery remains limited.
In this prospective, randomized, double-blind controlled trial, eligible adult patients scheduled for elective arthroscopic shoulder surgery under general anesthesia will be randomly assigned to receive either an ultrasound-guided ISB or SPSIP block. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
The primary endpoint will be total opioid consumption during the first 24 postoperative hours. Secondary endpoints will include postoperative Numeric Rating Scale (NRS) pain scores at predefined time points, quality of recovery assessed with the QoR-15 questionnaire, intraoperative opioid consumption, time to first rescue analgesic requirement, total rescue analgesic consumption, sensory block distribution, motor block assessment, and block-related adverse events.
The study aims to determine whether SPSIP block can provide postoperative analgesia comparable to ISB while potentially reducing complications associated with brachial plexus blockade.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
Bupivacaine administered for ultrasound-guided regional anesthesia block.
Time frame: 24 hours after surgery
Comparison of total postoperative opioid consumption between the interscalene brachial plexus block group and the serratus posterior superior intercostal plane block group during the first 24 hours after surgery.
Time frame: 0, 2, 4, 8, 16, and 24 hours after surgery
Numeric Rating Scale (NRS) pain scores at rest and during movement, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: 24 hours after surgery
Quality of Recovery-15 (QoR-15) score assessed 24 hours after surgery. Scores range from 0 to 150, with higher scores indicating better postoperative recovery and patient satisfaction.
Time frame: During surgery
Total remifentanil consumption during surgery.
Time frame: First 24 postoperative hours
Time elapsed from the end of surgery to the first rescue analgesic administration.
Time frame: First 24 postoperative hours
Total rescue analgesic consumption during the postoperative period.
Time frame: First 24 postoperative hours
Incidence of adverse events related to regional anesthesia techniques and opioid administration.
Contact information is provided by the study sponsor or research team.
Mürsel Ekinci, MD
CONTACT
Onur Güneş, MD
CONTACT
Ferit Yetik
Other Gov
Comparison of Interscalene Brachial Plexus Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Controlled Trial
Acronym: SISA
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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