NCT07343414

Brief Summary

This prospective observational study evaluates the effect of the anesthesia method (general anesthesia versus regional anesthesia \[interscalene nerve block/superficial cervical block\] with sedation) on the operating clarity of the surgical view and the surgeon's satisfaction during elective shoulder arthroscopy. The study investigates how these different anesthesia techniques influence intraoperative conditions, specifically bleeding amounts and the visibility of the surgical field, which are critical for the success of this minimally invasive procedure. Additionally, the research will monitor patient-centered outcomes, including postoperative pain levels, recovery time, and potential side effects such as nausea or vomiting, to determine which anesthesia strategy provides the optimal balance of surgical efficiency and patient comfort.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Feb 2026

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

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026May 2027

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Keywords

Shoulder ArthroscopySurgeon SatisfactionSurgical View QualityInterscalene Nerve BlockRotator Cuff Repair

Outcome Measures

Primary Outcomes (1)

  • Surgical View Clarity Score

    The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated by the surgeon using a 5-point Likert scale. The scale ranges from 1 (Poor/No Visualization) to 5 (Excellent/Crystal Clear Visualization).

    Intraoperative (assessed immediately upon completion of wound closure)

Secondary Outcomes (8)

  • Surgeon Satisfaction Score

    Intraoperative (assessed immediately upon completion of wound closure)

  • Intraarticular Bleeding Severity

    Intraoperative

  • Feasibility of Controlled Hypotension

    Intraoperative

  • Duration of Surgery

    Intraoperative

  • Duration of Anesthesia

    Intraoperative

  • +3 more secondary outcomes

Study Arms (2)

General Anesthesia Group

Patients undergoing elective shoulder arthroscopy who receive general anesthesia as determined by routine clinical practice and patient preference.

Regional Anesthesia Group

Patients undergoing elective shoulder arthroscopy who receive regional anesthesia \[interscalene nerve block/superficial cervical block\] combined with sedation as determined by routine clinical practice and patient preference.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients (aged 18 to 75 years) who are scheduled to undergo elective shoulder arthroscopy at the Sabuncuoğlu Şerefeddin Training and Research Hospital. These participants are recruited from the patient pool presenting to the Orthopedics and Traumatology clinic for surgical treatment of shoulder pathologies (rotator cuff tears or impingement). Participants include individuals with an ASA physical status of I, II, or III who are capable of providing informed consent .

You may qualify if:

  • Volunteers aged 18 to 75 years.
  • Patients scheduled for elective shoulder arthroscopy.
  • Patients with an ASA (American Society of Anesthesiologists) physical status score of I, II, or III.
  • Patients capable of providing informed consent.

You may not qualify if:

  • Previous surgical procedure performed on the same shoulder.
  • Presence of medical contraindications that could affect the choice of anesthesia (coagulopathy, active infection, severe pulmonary diseases)
  • Known allergy to local anesthetics or general anesthesia agents
  • History of opioid dependence or chronic pain syndrome
  • Presence of neurological disorders, particularly those involving the brachial plexus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Sabuncuoglu Serefeddin Educational and Research Hospital

Amasya, Turkey (Türkiye)

Location

Study Officials

  • Ahmet Salih Tüzen, M.D.

    Izmir Katip Celebi University Atatürk Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harun Tolga Duran, M.D.

CONTACT

Bülent Meriç Çam, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations