An interventional study of Ultrasound-Guided Interscalene Brachial Plexus Block and General Anesthesia in Rotator Cuff Tear, Shoulder Surgery and Postoperative Recovery, sponsored by Yuzuncu Yil University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Yuzuncu Yil University · Not applicable, Interventional, and Treatment
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 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 routine sedation. Supplemental intravenous fentanyl boluses (25-50 μg) were permitted intraoperatively if clinically required according to predefined haemodynamic criteria.
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.
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This study's enrollment of 34 is below the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Postoperative day 5 and day 14
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.
Time frame: Preoperative, 24 hours, and 48 hours postoperatively
Platelet count
Peripheral blood platelet counts measured preoperatively and postoperatively.
Time frame: 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.
Time frame: Within 48 hours postoperatively
Postoperative tramadol consumption
Total postoperative tramadol consumption recorded during the first 48 postoperative hours.
Time frame: Within 48 hours postoperatively
Time to mobilisation
Time from the end of surgery to first postoperative mobilisation, measured in hours.
Time frame: Up to 48 hours after surgery
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Time frame: Within 48 hours postoperatively
Plan to share: No — 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.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Yuzuncu Yil University