NCT07369271

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

January 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 8, 2026

Last Update Submit

January 17, 2026

Conditions

Keywords

Shoulder arthroscopypostoperative painregional anesthesiainterscalene blockerector spinae plane block

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Motor blockade severity

    Up to 48 hours postoperatively

  • analgesic consumption

    48 hours

  • Adverse events

    7 days

  • Duration of motor blockade

    Up to 48 hours postoperatively

  • Sensory blockade distribution

    Up to 48 hours postoperatively

  • +1 more secondary outcomes

Study Arms (3)

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.

Procedure: Continuous Cervical Erector Spinae Plane Block

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.

Procedure: Continuous Interscalene Block

Single-Shot Interscalene Block

OTHER

Observational

Procedure: No intervention

Interventions

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 Cervical Erector Spinae Plane 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.

Continuous Interscalene Block

as observational group

Single-Shot Interscalene Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for elective shoulder arthroscopic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Chung-Ren Dr. Lin, PhD

CONTACT

Yu-Lien Hsieh, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 27, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations