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NCT Number: NCT07369271

Continuous Cervical Erector Spinae Plane Block Versus Interscalene Nerve Block in Shoulder Arthroscopic Surgery

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.

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Key information

Conditions

Shoulder Arthroscopy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location contact

Department of Anesthesiology

CONTACT

[email protected]

+886-6-2353535 ext 5348

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Postoperative pain intensity within postoperative 24 hours

    Time frame: 2 hour, 6 hours, 12 hours, and 24 hours postoperatively

    Postoperative pain intensity will be assessed using a 0-10 visual analogue scale (VAS) at 2, 6, 12, and 24 hours after surgery.

Secondary outcomes

  1. Motor blockade severity

    Time frame: Up to 48 hours postoperatively

    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.

  2. analgesic consumption

    Time frame: 48 hours

    Rescue analgesic requirements and cumulative opioid consumption will be recorded and converted to oral morphine equivalent doses.

  3. Adverse events

    Time frame: 7 days

    Adverse events will include postoperative nausea and vomiting, signs or symptoms of local anesthetic systemic toxicity, infection, neurologic symptoms, and catheter-related complications.

  4. Duration of motor blockade

    Time frame: Up to 48 hours postoperatively

    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.

  5. Sensory blockade distribution

    Time frame: Up to 48 hours postoperatively

    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.

  6. Duration of sensory blockade

    Time frame: Up to 48 hours postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chung-Ren Dr. Lin, PhD

CONTACT

[email protected]

06-2353535

Yu-Lien Hsieh, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Continuous Cervical Erector Spinae Plane Block Versus Interscalene Nerve Block in Shoulder Arthroscopic Surgery- A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

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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