Rotator Cuff Tear, Shoulder Surgery, Wound Healing
Conditions
Keywords
peripheral nerve block, general anesthesia, immunity, wound healing, interscalene brachial plexus block, rotator cuff repair, randomized controlled trial
Brief 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.
Interventions
Ultrasound-guided interscalene brachial plexus block performed using 20 mL of 0.25% bupivacaine for anesthesia in patients undergoing open shoulder surgery.
PROCEDUREGeneral Anesthesia
Standardized general anesthesia using propofol, fentanyl, rocuronium, and sevoflurane in patients undergoing open shoulder surgery.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants were blinded to group allocation. Outcome assessors and laboratory personnel were also blinded to treatment assignment. The anesthesiologist performing the procedure was not blinded due to the nature of the intervention.
Intervention model description
This is a prospective, randomized, single-blind, parallel-group controlled trial comparing interscalene brachial plexus block with general anesthesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who were scheduled for elective open shoulder surgery.
Exclusion criteria
Patients with coagulation disorders, neuropathic disorders, diaphragmatic paralysis, allergy to local anesthetics, or severe cardiopulmonary disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early postoperative wound healing (TSAS-W score) | Postoperative day 5 and day 14 | Early postoperative wound healing assessed using the Toronto Symptom Assessment System for Wounds (TSAS-W), a validated patient-reported outcome measure evaluating wound-related symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative cytokine and growth factor levels | Preoperative, 24 hours, and 48 hours postoperatively | 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. |
| Platelet count | Preoperative, 24 hours, and 48 hours postoperatively | Peripheral blood platelet counts measured preoperatively and postoperatively. |
| Postoperative pain scores | Within 48 hours postoperatively | Pain intensity assessed using a standardized pain scale (e.g., Visual Analog Scale) during the first 48 hours after surgery. |
| Opioid consumption | Within 48 hours postoperatively | Total opioid consumption (expressed as morphine equivalents) recorded during the first 48 hours after surgery. |
| Time to mobilisation | Up to 48 hours after surgery | Time from the end of surgery to the first postoperative mobilisation, measured in hours |
| Postoperative nausea and vomiting | Within 48 hours postoperatively | Incidence of postoperative nausea and vomiting during the first 48 hours after surgery. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORArzu E Tekeli, MD
Yuzuncu Yil University
Outcome results
None listed