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

Rotator Cuff Tear, Shoulder Surgery, Postoperative Recovery

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

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

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 random sequence with allocation concealment by sequentially numbered sealed opaque envelopes. Due to the nature of the intervention, participants and the attending anaesthesiologist were not blinded. However, surgeons, outcome assessors, laboratory personnel, postoperative care staff, and the statistician remained blinded to group allocation whenever feasible. 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. 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 trial was retrospectively registered after participant enrolment had been completed. The registry record was subsequently updated to improve consistency with the final study protocol and reported analyses. These updates included clarification of outcome measures, biomarker analyses, and sample size reporting. No changes were made to the collected data after study completion.

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