NCT06855381

Brief Summary

Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

February 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

February 7, 2025

Last Update Submit

February 25, 2025

Conditions

Anesthesia

Keywords

interscalene block, pain management, regional anesthesia, shoulder arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Pain severity

    Tha pain severity will be evaluated by NRS scale

    24 hour, 48 hour, 72 hour, 7 day

Study Arms (2)

effectiveness of interscalene brachial plexus single-shot

ACTIVE COMPARATOR

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used

Procedure: single bolus injection

continuous interscalene brachial plexus block

EXPERIMENTAL

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this arm, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used.

Procedure: the ISBC group, SonoPlex needle and E-catheter

Interventions

the ISBC group, SonoPlex needle and E-catheterPROCEDURE

in the ISBC group, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. The E-catheter will be inserted into the indwelling cannula.

continuous interscalene brachial plexus block
single bolus injectionPROCEDURE

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used

effectiveness of interscalene brachial plexus single-shot

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesia (ASA) physical status of 1 to 2,
  • Body Mass Index (BMI) of less than 30 kg/m²,
  • paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.

You may not qualify if:

  • skin infection on the puncture site,
  • coagulopathy
  • brachial plexus neuropathy
  • alcohol or drug abuse
  • diabetes
  • severe lung disease
  • history of allergy to one or more study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico

Foggia, Italy

Location

Related Publications (1)

  • Uno T, Mura N, Yuki I, Oishi R, Takagi M. The effect of continuous interscalene brachial plexus block for arthroscopic rotator cuff repair. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2024 Feb 2;36:6-12. doi: 10.1016/j.asmart.2024.01.004. eCollection 2024 Apr.

    PMID: 38344106BACKGROUND

Related Links

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 7, 2025

First Posted

March 3, 2025

Study Start

February 1, 2022

Primary Completion

February 28, 2024

Study Completion

February 28, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)