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Interscalene Brachial Plexus Block and Early Wound-Related Symptoms After Open Rotator Cuff Repair

NCT05499897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-06-01

No results posted yet for this study

Summary

This exploratory randomized controlled trial evaluated the association of interscalene brachial plexus block (ISB) with early postoperative wound-related symptom scores and perioperative biomarker responses in patients undergoing open rotator cuff repair.

Participants were randomly allocated to receive either ultrasound-guided interscalene brachial plexus block or standardized general anaesthesia. The primary outcome was postoperative wound-related assessment using the Toronto Symptom Assessment System for Wounds (TSAS-W) on postoperative days 5 and 14. TSAS-W was used as an exploratory patient-reported wound symptom assessment tool.

Secondary outcomes included perioperative serum cytokine and growth-factor concentrations (IL-1β, IL-2, TNF-α, EGF, PDGF, and TGF-β), platelet counts, postoperative pain scores, tramadol consumption within 48 hours, time to mobilisation, and postoperative nausea and vomiting.

This study aimed to investigate whether interscalene brachial plexus block was associated with differences in perioperative biological responses and postoperative wound-related symptom scores compared with general anaesthesia.

Conditions

  • Rotator Cuff Tear
  • Shoulder Surgery
  • Postoperative Recovery

Interventions

PROCEDURE

Ultrasound-Guided Interscalene Brachial Plexus Block

Ultrasound-guided interscalene brachial plexus block performed using 20 mL of 0.25% bupivacaine in patients undergoing open rotator cuff repair. Surgery was performed under awake regional anaesthesia without sedation or intraoperative opioids.

PROCEDURE

General Anesthesia

Standardized general anaesthesia using propofol, fentanyl, rocuronium, and sevoflurane in patients undergoing open rotator cuff repair. Additional intraoperative fentanyl was administered according to haemodynamic responses.

Sponsors & Collaborators

  • Yuzuncu Yil University

    lead OTHER

Principal Investigators

  • Arzu E Tekeli, MD · Yuzuncu Yil University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-01-01
Completion
2023-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05499897 on ClinicalTrials.gov