Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 26-AKD-92 | Other Identifier | Bursa City Hospital Clinical Research Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bursa Sehir Hastanesi | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interscalene Brachial Plexus Block Group | Experimental | Participants receive an ultrasound-guided interscalene brachial plexus block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery. |
|
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interscalene Brachial Plexus Block | Procedure | Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption During the First 24 Postoperative Hours | 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. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores | 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. | 0, 2, 4, 8, 16, and 24 hours after surgery |
| Quality of Recovery (QoR-15) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mürsel Ekinci, MD | Contact | +905067137596 | drmurselekinci@gmail.com | |
| Onur Güneş, MD | Contact | +905319418938 | onurguness96@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mürsel Ekinci | University of Health Sciences, Bursa Faculty of Medicine, Bursa City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital | Recruiting | Bursa | Nilüfer | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomly assigned in a 1:1 ratio to receive either an ultrasound-guided interscalene brachial plexus block or a serratus posterior superior intercostal plane block before arthroscopic shoulder surgery.
Not provided
Not provided
Double (Participant, Outcomes Assessor)
| Serratus Posterior Superior Intercostal Plane Block | Procedure | Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery. |
|
| Bupivacaine | Drug | Bupivacaine administered for ultrasound-guided regional anesthesia block. |
|
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. |
| 24 hours after surgery |
| Intraoperative Remifentanil Consumption | Total remifentanil consumption during surgery. | During surgery |
| Time to First Rescue Analgesic Requirement | Time elapsed from the end of surgery to the first rescue analgesic administration. | First 24 postoperative hours |
| Rescue Analgesic Consumption | Total rescue analgesic consumption during the postoperative period. | First 24 postoperative hours |
| Block-Related and Opioid-Related Complications | Incidence of adverse events related to regional anesthesia techniques and opioid administration. | First 24 postoperative hours |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided