Continuous Cervical Erector Spinae Plane Block Versus Interscalene Nerve Block in Shoulder Arthroscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Cervical Erector Spinae Plane Block, Continuous Interscalene Block, No intervention.
- Who it may be relevant to
- Registry conditions: Shoulder Arthroscopy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Cervical Erector Spinae Plane Block Versus Interscalene Nerve Block in Shoulder Arthroscopic Surgery- A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Procedure Continuous Cervical Erector Spinae Plane Block
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. - Procedure Continuous Interscalene Block
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. - Procedure No intervention
as observational group
Primary outcome measures
- Postoperative pain intensity within postoperative 24 hours [Time frame: 2 hour, 6 hours, 12 hours, and 24 hours postoperatively]
Secondary outcome measures (6)
- Motor blockade severity [Time frame: Up to 48 hours postoperatively]
- analgesic consumption [Time frame: 48 hours]
- Adverse events [Time frame: 7 days]
- Duration of motor blockade [Time frame: Up to 48 hours postoperatively]
- Sensory blockade distribution [Time frame: Up to 48 hours postoperatively]
- Duration of sensory blockade [Time frame: Up to 48 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Adult patients scheduled for elective shoulder arthroscopic surgery
Exclusion criteria
- Contraindications to regional analgesia
- BMI >40
- ASA physical status IV
- history of drug or opioid abuse
- preoperative upper limb motor impairment
- postoperative ventilator support or ICU admission
- Inability to provide self-reported pain assessments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Cheng Kung University Hospital — Tainan
Identifiers
NCT: NCT07369271 · B-ER-114-324