Postoperative Pain, Shoulder Arthroscopy
Conditions
Keywords
Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Ultrasound-Guided Nerve Block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInterscalene Brachial Plexus Block
Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
PROCEDURESerratus Posterior Superior Intercostal Plane Block
Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
DRUGBupivacaine
Bupivacaine administered for ultrasound-guided regional anesthesia block.
Sponsors
Ferit Yetik
Bursa Sehir Hastanesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Double (Participant, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years * ASA physical status I, II, or III * Scheduled for elective arthroscopic shoulder surgery under general anesthesia * Provision of written informed consent
Exclusion criteria
* Refusal to participate in the study * Coagulopathy * Current anticoagulant therapy * Infection at the block site * Previous surgery involving the planned block site * Known allergy or history of toxicity to local anesthetics * Hepatic failure * Renal failure * Uncontrolled diabetes mellitus * Cognitive impairment or mental disability preventing reliable assessment * Chronic opioid use or ongoing chronic pain treatment * Pregnancy, suspected pregnancy, or breastfeeding * Chronic pulmonary disease (e.g., COPD or asthma) * Failed block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption During the First 24 Postoperative Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | 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. |
| Quality of Recovery (QoR-15) | 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. |
| Intraoperative Remifentanil Consumption | During surgery | Total remifentanil consumption during surgery. |
| Time to First Rescue Analgesic Requirement | First 24 postoperative hours | Time elapsed from the end of surgery to the first rescue analgesic administration. |
| Rescue Analgesic Consumption | First 24 postoperative hours | Total rescue analgesic consumption during the postoperative period. |
| Block-Related and Opioid-Related Complications | First 24 postoperative hours | Incidence of adverse events related to regional anesthesia techniques and opioid administration. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMürsel Ekinci, MD
CONTACTOnur Güneş, MD
PRINCIPAL_INVESTIGATORMürsel Ekinci
University of Health Sciences, Bursa Faculty of Medicine, Bursa City Hospital
Outcome results
None listed