NCT06883279

Brief Summary

In this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the Numerical Rating Scale (NRS) (NRS ≥ 7).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

March 9, 2025

Last Update Submit

November 14, 2025

Conditions

AnesthesiaPain, ShoulderPain, Postoperative

Keywords

AnesthesiaInterscalene blockRebound pain

Outcome Measures

Primary Outcomes (1)

  • Rebound pain

    Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7).

    36 hours

Secondary Outcomes (16)

  • Number of needle passes

    During the block procedure time

  • Block performance time

    During the block procedure time

  • Rescue analgesic

    36 hours

  • Duration of rebound pain

    36 hours

  • Onset of sensory block

    Preoperative time

  • +11 more secondary outcomes

Study Arms (2)

Intraplexus approach in interscalene block

ACTIVE COMPARATOR

The block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed

Other: Intraplexus

Extraplexus approach in interscalene block

ACTIVE COMPARATOR

The block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered.

Other: Extraplexus

Interventions

IntraplexusOTHER

The block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed

Intraplexus approach in interscalene block
ExtraplexusOTHER

The block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered.

Extraplexus approach in interscalene block

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65 years.
  • Patients with ASA physical status I or II.
  • Patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block.

You may not qualify if:

  • Patients who do not consent to participate in the study.
  • Block failure.
  • Language acquisition deficiency.
  • Obesity (body mass index \> 35 kg/m²).
  • Diabetes.
  • Psychiatric disorders.
  • Central nervous system diseases.
  • Vestibular diseases.
  • Presence of neuropathy and paralysis.
  • Pregnancy.
  • Previous open shoulder surgery.
  • Allergy to local anesthetics.
  • Coagulopathy.
  • Severe thrombocytopenia.
  • Infection at the puncture site.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder PainPain, Postoperative

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

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
Anesthesiology and Reanimation specialist doctor

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 19, 2025

Study Start

March 20, 2025

Primary Completion

September 10, 2025

Study Completion

October 20, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)