NCT05499897

The Effect of Interscalene Block on Wound Healing and Immunity in Open Shoulder Surgeries

The Effect of Interscalene Brachial Plexus Block on Wound Healing and Perioperative Immunological Response in Open Shoulder Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Yuzuncu Yil University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aimed to evaluate the effect of interscalene brachial plexus block (ISB) on early postoperative wound healing and perioperative biological responses in patients undergoing open rotator cuff repair. Participants were randomly allocated to receive either ISB or general anesthesia (GA). The primary outcome was early wound healing assessed 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 levels (IL-1β, IL-2, TNF-α, EGF, PDGF, TGF-β), platelet counts, postoperative pain scores, opioid consumption, time to mobilisation, and postoperative nausea and vomiting. The study hypothesis was that ISB would improve early wound healing and promote a pro-regenerative biomarker profile compared with GA.

Detailed description

Study Design and Participants This prospective, 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 assigned in a 1:1 ratio to receive either ultrasound-guided interscalene brachial plexus block (ISB) or general anesthesia (GA). Randomization was performed using a computer-generated sequence with allocation concealment by sealed opaque envelopes. Patients, surgeons, outcome assessors, and laboratory personnel were blinded to group allocation. Interventions Patients in the ISB group received an ultrasound-guided interscalene block using 20 mL of 0.25% bupivacaine prior to surgery. Patients in the GA group received standardized general anesthesia with propofol, fentanyl, rocuronium, and sevoflurane. Outcomes and Data Collection The primary outcome was early postoperative wound healing assessed using the Toronto Symptom Assessment System for Wounds (TSAS-W) on postoperative days 5 and 14. Secondary outcomes included perioperative serum concentrations of cytokines (IL-1β, IL-2, TNF-α) and growth factors (EGF, PDGF, TGF-β), platelet counts, postoperative pain scores, opioid consumption within 48 hours, time to mobilisation, and postoperative nausea and vomiting. Blood samples were collected preoperatively and at 24 and 48 hours postoperatively. All laboratory analyses were performed using standardized methods with blinded assessment. Protocol Amendments The trial was prospectively registered; however, the registry was updated after study completion to improve clarity and alignment with the final study design and reported outcomes. These updates included clarification of outcome measures and final sample size based on feasibility considerations. No changes were made to the collected data or statistical analyses after study completion.

Conditions

• Rotator Cuff Tear
• Shoulder Surgery
• Wound Healing

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-Guided Interscalene Brachial Plexus Block	Ultrasound-guided interscalene brachial plexus block performed using 20 mL of 0.25% bupivacaine for anesthesia in patients undergoing open shoulder surgery.
PROCEDURE	General Anesthesia	Standardized general anesthesia using propofol, fentanyl, rocuronium, and sevoflurane in patients undergoing open shoulder surgery.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2022-08-12
• Last updated: 2026-03-30

Locations

1 site across 1 country: Turkey (Türkiye)