Rotator Cuff TearNCT05499897
Interscalene Brachial Plexus Block and Early Wound-Related Symptoms After Open Rotator Cuff Repair
A study testing Ultrasound-Guided Interscalene Brachial Plexus Block and General Anesthesia in people with Rotator Cuff Tear and Shoulder Surgery, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear, Shoulder Surgery, Postoperative Recovery
- What is being tested?
- Ultrasound-Guided Interscalene Brachial Plexus Block and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2023to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Known coagulopathy
- Chronic renal insufficiency
- Chronic hepatic insufficiency
- Significant uncontrolled cardiopulmonary disease
- Chronic opioid use
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yil University
Van, Bardakçı, 65100
About this study
Official title: Interscalene Brachial Plexus Block is Associated With Lower Patient-Reported Wound Symptom Scores and Altered Perioperative Biomarker Profiles Following Open Rotator Cuff Repair: An Exploratory Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Rotator Cuff Tear, Shoulder Surgery, Postoperative Recovery
- Being tested
- Ultrasound-Guided Interscalene Brachial Plexus Block, General Anesthesia
- Keywords
- peripheral nerve block, general anesthesia, interscalene brachial plexus block, rotator cuff repair, randomized controlled trial, perioperative biomarkers, regional anaesthesia
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Interscalene Brachial Plexus BlockProcedure or surgery
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.
General AnesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia Group | Active comparator | 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. Receives: Procedure: General Anesthesia |
| Interscalene Block Group | Experimental | 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. Receives: Procedure: Ultrasound-Guided Interscalene Brachial Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 5 and day 14
Secondary outcomes (6)
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.
Measured: Preoperative, 24 hours, and 48 hours postoperatively
Platelet count
Peripheral blood platelet counts measured preoperatively and postoperatively.
Measured: 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.
Measured: Within 48 hours postoperatively
Postoperative tramadol consumption
Total postoperative tramadol consumption recorded during the first 48 postoperative hours.
Measured: Within 48 hours postoperatively
Time to mobilisation
Time from the end of surgery to first postoperative mobilisation, measured in hours.
Measured: Up to 48 hours after surgery
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.
Measured: Within 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start3 Feb 2023
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel-group controlled trial comparing ultrasound-guided interscalene brachial plexus block with general anaesthesia in patients undergoing open rotator cuff repair. Due to the nature of the intervention, participants and attending anaesthesiologists were not blinded. Outcome assessors, laboratory personnel, postoperative care staff, and the statistician remained blinded to group allocation whenever feasible.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- Arzu E Tekeli, MD, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499897
- Sponsor's protocol ID
- 2022/14
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2022
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Brachial Plexus Block is Associated With Lower Patient-Reported Wound Symptom Scores and Altered Perioperative Biomarker Profiles Following Open Rotator Cuff Repair: An Exploratory Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05499897
- Acronym / sponsor ID
- 2022/14
- Conditions
- Rotator Cuff Tear, Shoulder Surgery, Postoperative Recovery
- Keywords
- peripheral nerve block, general anesthesia, interscalene brachial plexus block, rotator cuff repair, randomized controlled trial, perioperative biomarkers, regional anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-group controlled trial comparing ultrasound-guided interscalene brachial plexus block with general anaesthesia in patients undergoing open rotator cuff repair. Due to the nature of the intervention, participants and attending anaesthesiologists were not blinded. Outcome assessors, laboratory personnel, postoperative care staff, and the statistician remained blinded to group allocation whenever feasible.
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | Active comparator | Procedure: General AnesthesiaPatients 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. |
| Interscalene Block Group | Experimental | Procedure: Ultrasound-Guided Interscalene Brachial Plexus BlockPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Pregnancy or lactation
- Known coagulopathy
- Chronic renal insufficiency
- Chronic hepatic insufficiency
- Significant uncontrolled cardiopulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Interscalene Brachial Plexus BlockUltrasound-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. | Procedure or surgery | Interscalene Block Group |
| General AnesthesiaStandardized general anaesthesia using propofol, fentanyl, rocuronium, and sevoflurane in patients undergoing open rotator cuff repair. Additional intraoperative fentanyl was administered according to haemodynamic responses. | Procedure or surgery | General Anesthesia Group |
Primary outcome
Early postoperative wound-related symptom scores (TSAS-W)
Time frame: Postoperative day 5 and day 14
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.
6 secondary outcomes
Perioperative cytokine and growth factor levels
Time frame: Preoperative, 24 hours, and 48 hours postoperatively
Platelet count
Time frame: Preoperative, 24 hours, and 48 hours postoperatively
Postoperative pain scores
Time frame: Within 48 hours postoperatively
Postoperative tramadol consumption
Time frame: Within 48 hours postoperatively
Time to mobilisation
Time frame: Up to 48 hours after surgery
Postoperative nausea and vomiting
Time frame: Within 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arzu E Tekeli, MD principal investigator
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Interscalene Brachial Plexus Block and General Anesthesia in people with Rotator Cuff Tear and Shoulder Surgery, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative wound-related symptom scores (TSAS-W) (time frame: Postoperative day 5 and day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.