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

NCT05499897 | Completed

• 1 other identifier: 2022/14
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peripheral nerve block; general anesthesia; interscalene brachial plexus block; rotator cuff repair; randomized controlled trial; perioperative biomarkers; regional anaesthesia

Outcome Measures

Primary Outcomes (1)

• Early postoperative wound-related symptom scores (TSAS-W)

  Early postoperative wound-related symptoms assessed using the Toronto Symptom Assessment System for Wounds (TSAS-W), a patient-reported wound symptom assessment tool originally developed for chronic wound settings. TSAS-W was used as an exploratory patient-reported symptom assessment instrument rather than as an objective measure of wound healing.

  Postoperative day 5 and day 14

Secondary Outcomes (6)

• Perioperative cytokine and growth factor levels

  Preoperative, 24 hours, and 48 hours postoperatively

• Platelet count

  Preoperative, 24 hours, and 48 hours postoperatively

• Postoperative pain scores

  Within 48 hours postoperatively

• Postoperative tramadol consumption

  Within 48 hours postoperatively

• Time to mobilisation

  Up to 48 hours after surgery

Study Arms (2)

General Anesthesia Group

ACTIVE COMPARATOR

Patients undergoing open rotator cuff repair under standardized general anaesthesia. General anaesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane. Additional intraoperative fentanyl was administered according to haemodynamic responses. Postoperative analgesia included paracetamol and rescue tramadol.

Procedure: General Anesthesia

Interscalene Block Group

EXPERIMENTAL

Patients undergoing open rotator cuff repair with ultrasound-guided interscalene brachial plexus block using 20 mL of 0.25% bupivacaine. Surgery was performed under awake regional anaesthesia without routine sedation. Supplemental intravenous fentanyl boluses were permitted intraoperatively if clinically required according to predefined haemodynamic criteria. Postoperative analgesia included paracetamol and rescue tramadol.

Procedure: Ultrasound-Guided Interscalene Brachial Plexus Block

Interventions

General Anesthesia PROCEDURE

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.

General Anesthesia Group

Ultrasound-Guided Interscalene Brachial Plexus Block PROCEDURE

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.

Interscalene Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-65 years
• American Society of Anesthesiologists (ASA) physical status I-II
• Scheduled for elective open repair of a full-thickness rotator cuff tear

You may not qualify if:

• Pregnancy or lactation
• Known coagulopathy
• Chronic renal insufficiency
• Chronic hepatic insufficiency
• Significant uncontrolled cardiopulmonary disease
• Chronic opioid use
• Immunosuppressive therapy
• Diabetes mellitus or other uncontrolled metabolic disorders potentially affecting wound healing
• Chronic inflammatory disease
• Morbid obesity (body mass index ≥35 kg/m²)
• Allergy to amide local anaesthetics
• Infection at the injection site
• Emergency surgery
• Inability to complete postoperative assessments

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yil University

Van, Bardakçı, 65100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Arzu E Tekeli, MD

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors, laboratory personnel, postoperative care staff, and the statistician were blinded to treatment allocation whenever feasible. Due to the nature of the intervention, participants and attending anaesthesiologists were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective, randomized, parallel-group controlled trial comparing ultrasound-guided interscalene brachial plexus block with general anaesthesia in patients undergoing open rotator cuff repair. Due to the nature of the intervention, participants and attending anaesthesiologists were not blinded. Outcome assessors, laboratory personnel, postoperative care staff, and the statistician remained blinded to group allocation whenever feasible.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 12, 2022
• Study Start: February 3, 2023
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)