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Shoulder arthroscopic surgery is associated with moderate to severe postoperative pain, which may hinder early mobilization and functional recovery. Interscalene block (ISB) is commonly used to provide effective analgesia but is frequently associated with hemidiaphragmatic paralysis due to phrenic nerve involvement. Cervical erector spinae plane block (ESPB) has been proposed as an alternative regional technique that may provide analgesia while reducing respiratory-related adverse effects. This randomized controlled trial aims to compare the analgesic efficacy and safety of cervical ESPB versus continuous ISB in patients undergoing shoulder arthroscopic surgery.
This study is a prospective randomized controlled trial designed to evaluate whether continuous cervical erector spinae plane block (ESPB) is non-inferior to continuous interscalene block (ISB) for postoperative pain control in adult patients undergoing elective shoulder arthroscopic surgery. Eligible participants will be allocated to one of three groups: continuous cervical ESPB, continuous ISB, or a prospective observational control group receiving standard institutional analgesia with single-shot ISB.
Randomization with allocation concealment will be applied to the two interventional groups. Patients and outcome assessors will be blinded to group allocation. All regional anesthesia techniques will be performed as part of a standardized multimodal analgesic protocol.
The primary outcome is postoperative pain intensity measured using the visual analogue scale (VAS) at 24 hours after surgery. Secondary outcomes include pain scores at additional postoperative time points, cumulative opioid consumption expressed as oral morphine equivalents, measures of functional recovery, and the incidence of block-related adverse events. Respiratory-related outcomes, including hemidiaphragmatic paralysis assessed by ultrasound, as well as motor and sensory deficits and postoperative nausea and vomiting, will also be evaluated.
Analyses of the randomized intervention groups will be conducted on an intention-to-treat basis. Data from the observational control group will be analyzed descriptively to provide reference information on usual-care outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Cervical Erector Spinae Plane Block | Experimental | Participants will receive an ultrasound-guided continuous cervical erector spinae plane block with perineural catheter placement as part of a standardized multimodal analgesia regimen for shoulder arthroscopic surgery. Postoperative analgesia will be provided via continuous local anesthetic infusion through the catheter per institutional protocol. |
|
| Continuous Interscalene Block | Active Comparator | Participants will receive an ultrasound-guided continuous interscalene block with perineural catheter placement as part of a standardized multimodal analgesia regimen for shoulder arthroscopic surgery. Postoperative analgesia will be provided via continuous local anesthetic infusion through the catheter per institutional protocol. |
|
| Single-Shot Interscalene Block | Other | Observational |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Cervical Erector Spinae Plane Block | Procedure | An ultrasound-guided cervical erector spinae plane block with catheter placement will be performed. Local anesthetic will be administered through the catheter to provide continuous postoperative analgesia according to institutional protocol as part of a standardized multimodal analgesic regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity within postoperative 24 hours | Postoperative pain intensity will be assessed using a 0-10 visual analogue scale (VAS) at 2, 6, 12, and 24 hours after surgery. | 2 hour, 6 hours, 12 hours, and 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Motor blockade severity | Motor blockade severity in the operated upper extremity will be assessed using a standardized muscle strength grading scale ranging from 0 to 5, where 0 indicates no muscle contraction and 5 indicates normal muscle strength. | Up to 48 hours postoperatively |
| analgesic consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chung-Ren Dr. Lin, PhD | Contact | 06-2353535 | n104065@mail.hosp.ncku.edu.tw | |
| Yu-Lien Hsieh, MD | Contact | hsiehyulien@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
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|
| Continuous Interscalene Block | Procedure | An ultrasound-guided interscalene block with catheter placement will be performed. Local anesthetic will be administered through the catheter to provide continuous postoperative analgesia according to institutional protocol as part of a standardized multimodal analgesic regimen. |
|
| No intervention | Procedure | as observational group |
|
Rescue analgesic requirements and cumulative opioid consumption will be recorded and converted to oral morphine equivalent doses. |
| 48 hours |
| Adverse events | Adverse events will include postoperative nausea and vomiting, signs or symptoms of local anesthetic systemic toxicity, infection, neurologic symptoms, and catheter-related complications. | 7 days |
| Duration of motor blockade | The duration of motor blockade will be defined as the time from completion of surgery to recovery of normal motor function, defined as a muscle strength grade of 5 on the standardized 0-5 muscle strength scale, in the operated upper extremity. | Up to 48 hours postoperatively |
| Sensory blockade distribution | The anatomical distribution of sensory blockade will be assessed using standardized sensory examination (e.g., response to pinprick or cold sensation) across predefined dermatomal regions of the operated upper extremity. | Up to 48 hours postoperatively |
| Duration of sensory blockade | The duration of sensory blockade will be defined as the time from completion of surgery to recovery of normal sensation in the operated upper extremity, as assessed by standardized clinical sensory examination. | Up to 48 hours postoperatively |
| 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 |
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