NCT07689448

Brief Summary

This study is evaluating whether the timing of an interscalene nerve block affects pain control and recovery after arthroscopic rotator cuff repair surgery. An interscalene block is commonly used to reduce pain after shoulder surgery. However, it is not known whether administering the block before surgery or after surgery provides better outcomes. Participants undergoing arthroscopic rotator cuff repair are assigned to receive the interscalene block either before the surgical incision or after completion of the procedure. The study compares postoperative pain levels, opioid medication use, length of hospital stay, and ultrasound imaging quality during block administration between the two groups. Functional recovery is also assessed using patient-reported outcome measures during follow-up. The investigators hypothesize that administration of the interscalene block before surgery may provide superior early pain control and reduce postoperative opioid requirements while maintaining similar functional outcomes compared with administration after surgery.

Trial Health

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Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jul 2026

Shorter than P25 for all trials

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 Progress20%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

June 24, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 24, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Rotator Cuff TearsArthroscopic Rotator Cuff RepairInterscalene Nerve BlockRegional AnesthesiaPostoperative PainPreemptive AnalgesiaPain Management

Outcome Measures

Primary Outcomes (1)

  • Early Postoperative Pain Intensity

    Patients' postoperative pain intensity measured using the Visual Analog Scale (VAS) following arthroscopic rotator cuff repair. Pain scores will be compared between pre-procedure and post-procedure interscalene block groups. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.

    Pre-procedure, postoperative 6th, 12th, 24th hours

Secondary Outcomes (6)

  • Postoperative Opioid Consumption

    24 hours after surgery

  • Patient-Controlled Analgesia Usage

    24 hours after surgery

  • Duration of hospitalization following arthroscopic rotator cuff repair.

    From surgery until hospital discharge

  • Ultrasound Image Quality During Interscalene Block Administration

    At the time of interscalene block administration

  • Oxford Shoulder Score

    Baseline, 3 months, and 6 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Pre-Procedure Interscalene Block

Participants undergoing arthroscopic rotator cuff repair who received an ultrasound-guided interscalene nerve block before surgical incision as part of the perioperative analgesia protocol.

Post-Procedure Interscalene Block

Participants undergoing arthroscopic rotator cuff repair who received an ultrasound-guided interscalene nerve block after completion of surgery as part of the perioperative analgesia protocol.

Eligibility Criteria

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

Adult patients undergoing primary arthroscopic rotator cuff repair for repairable rotator cuff tears at a single tertiary referral center. Participants received ultrasound-guided interscalene nerve block either before surgical incision or after completion of surgery according to routine perioperative practice.

You may qualify if:

  • Adults aged 18 years or older.
  • Patients undergoing primary arthroscopic rotator cuff repair.
  • Presence of a repairable small-, medium-, or large-sized rotator cuff tear confirmed by clinical and imaging evaluation.
  • Receipt of an ultrasound-guided interscalene nerve block as part of perioperative pain management.
  • Ability to provide informed consent and comply with study follow-up requirements.

You may not qualify if:

  • Irreparable rotator cuff tears.
  • Partial-thickness rotator cuff tears not requiring repair.
  • Revision rotator cuff repair procedures.
  • Concomitant shoulder procedures that could substantially influence postoperative pain or functional outcomes (e.g., shoulder arthroplasty, fracture fixation).
  • Previous surgery on the affected shoulder.
  • Contraindications to interscalene nerve block, including local anesthetic allergy, infection at the injection site, or severe neurologic disease affecting the brachial plexus.
  • Chronic opioid use or opioid dependence before surgery.
  • Inability to complete study questionnaires or follow the postoperative rehabilitation protocol.
  • Missing baseline or follow-up data required for outcome assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Bahcesehir Liv Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesPain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Ali S. Kavaklı, Professor

    Istinye University

    STUDY CHAIR
  • Onur Senyurt, MD

    Istinye University

    PRINCIPAL INVESTIGATOR
  • Kaya Turan, MD, Assoc Prof

    Istinye University

    STUDY DIRECTOR
  • Taylan Sahin, MD

    Istinye University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaya Turan, MD, FEBOT, Assoc Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 8, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because of institutional and ethical restrictions related to participant confidentiality and privacy protection.

Locations