Interscalene Brachial Plexus Block and Early Wound-Related Symptoms After Open Rotator Cuff Repair (NCT05499897) | Clinical Trial Compass
CompletedNot Applicable
Interscalene Brachial Plexus Block and Early Wound-Related Symptoms After Open Rotator Cuff Repair
Turkey (Türkiye)34 participantsStarted 2023-02-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early postoperative wound-related symptom scores (TSAS-W)