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

Interscalene Brachial Plexus Block is Associated With Lower Patient-Reported Wound Symptom Scores and Altered Perioperative Biomarker Profiles Following Open Rotator Cuff Repair: An Exploratory Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear; Shoulder Surgery; Postoperative Recovery
• Intervention / Treatment: Procedure: General Anesthesia; Procedure: Ultrasound-Guided Interscalene Brachial Plexus Block

Detailed Description

Study Design and Participants

This prospective, parallel-group randomized controlled trial included adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective open rotator cuff repair.

Participants were randomly allocated in a 1:1 ratio to receive either ultrasound-guided interscalene brachial plexus block (ISB) or general anaesthesia (GA). Randomization was performed using a computer-generated block randomization sequence with a fixed block size of four. Allocation concealment was achieved using sequentially numbered opaque sealed envelopes prepared by an investigator not otherwise involved in patient care or outcome assessment.

Due to the nature of the intervention, participants and the attending anaesthesiologist were not blinded. The operating surgeon was aware of group allocation because of the visible differences in perioperative anaesthetic management. However, laboratory personnel, postoperative outcome assessors, postoperative care staff, and the statistician remained blinded to group allocation whenever feasible.

A total of 34 participants were randomized. Two participants in the general anaesthesia group were excluded after randomization (one protocol violation and one missing follow-up), leaving 32 participants (GA n=15; ISB n=17) for per-protocol analysis.

Interventions

Patients in the ISB group received ultrasound-guided interscalene brachial plexus block using 20 mL of 0.25% bupivacaine. Surgery in the ISB group was performed under awake regional anaesthesia without sedation or intraoperative opioids.

Patients in the GA group received standardized general anaesthesia with propofol, fentanyl, rocuronium, and sevoflurane.

Outcomes and Data Collection

The primary outcome was early postoperative wound-related assessment using the Toronto Symptom Assessment System for Wounds (TSAS-W) on postoperative days 5 and 14. TSAS-W is a patient-reported wound symptom assessment tool originally developed for chronic wound settings and was used as an exploratory symptom assessment instrument rather than as an objective measure of wound healing.

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, total postoperative tramadol consumption within 48 hours, time to mobilisation, and postoperative nausea and vomiting.

Blood samples were collected preoperatively and at 24 and 48 hours postoperatively. Laboratory analyses were performed using standardized enzyme-linked immunosorbent assay methods.

Protocol Registration The study protocol was registered at ClinicalTrials.gov (NCT05499897). Administrative updates to the registry record were made during and after study completion to improve consistency with the final protocol and reported analyses. These updates included clarification of outcome measures, biomarker analyses, sample size reporting, and administrative study dates. No changes were made to the collected data or analyses after study completion.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bardakçı
    • Van, Bardakçı, Turkey (Türkiye), 65100
      • Van Yüzüncü Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia Group; 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; 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.
Experimental: Interscalene Block Group; 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 general anaesthesia or routine sedation. Supplemental fentanyl boluses were permitted if clinically required. Postoperative analgesia included paracetamol and rescue tramadol.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative cytokine and growth factor levels	Serum levels of cytokines (IL-1β, IL-2, TNF-α) and growth factors (EGF, PDGF, TGF-β) measured preoperatively and at 24 and 48 hours postoperatively.	Preoperative, 24 hours, and 48 hours postoperatively
Platelet count	Peripheral blood platelet counts measured preoperatively and postoperatively.	Preoperative, 24 hours, and 48 hours postoperatively
Postoperative pain scores	Pain intensity assessed using a standardized pain scale (e.g., Visual Analog Scale) during the first 48 hours after surgery.	Within 48 hours postoperatively
Postoperative tramadol consumption	Total postoperative tramadol consumption recorded during the first 48 postoperative hours.	Within 48 hours postoperatively
Time to mobilisation	Time from the end of surgery to first postoperative mobilisation, measured in hours.	Up to 48 hours after surgery
Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.	Within 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Yuzuncu Yil University
• Investigators: Principal Investigator: Arzu E Tekeli, MD, Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; general anesthesia; regional anaesthesia; rotator cuff repair; interscalene brachial plexus block; peripheral nerve block; perioperative biomarkers
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Anesthesia and Analgesia; Anesthesia; Anesthesia, General
• Other Study ID Numbers: 2022/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are not planned to be shared because the study involved a small exploratory sample and no formal data-sharing framework was established at the time of study conduct.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No