Rotator Cuff Tear RepairISB-ARCRNCT07689448
Preoperative Versus Postoperative Interscalene Block in Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tear Repair and Interscalene Blocks, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study is evaluating whether the timing of an interscalene nerve block affects pain control and recovery after arthroscopic rotator cuff repair surgery. An interscalene block is commonly used to reduce pain after shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear Repair, Interscalene Blocks, Rotator Cuff Tears
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2026to 20 Oct 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing primary arthroscopic rotator cuff repair for repairable rotator cuff tears at a single tertiary referral center. Participants received ultrasound-guided interscalene nerve block either before surgical incision or after completion of surgery according to routine perioperative practice.
Who may be able to join
- Adults aged 18 years or older.
- Patients undergoing primary arthroscopic rotator cuff repair.
- Presence of a repairable small-, medium-, or large-sized rotator cuff tear confirmed by clinical and imaging evaluation.
- Receipt of an ultrasound-guided interscalene nerve block as part of perioperative pain management.
- Ability to provide informed consent and comply with study follow-up requirements.
Who cannot join
- Irreparable rotator cuff tears.
- Partial-thickness rotator cuff tears not requiring repair.
- Revision rotator cuff repair procedures.
- Concomitant shoulder procedures that could substantially influence postoperative pain or functional outcomes (e.g., shoulder arthroplasty, fracture fixation).
- Previous surgery on the affected shoulder.
- Contraindications to interscalene nerve block, including local anesthetic allergy, infection at the injection site, or severe neurologic disease affecting the brachial plexus.
Show all 9Show fewer
- Chronic opioid use or opioid dependence before surgery.
- Inability to complete study questionnaires or follow the postoperative rehabilitation protocol.
- Missing baseline or follow-up data required for outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye University Bahcesehir Liv Research and Training Hospital
Istanbul
About this study
Official title: Pre-Procedure Versus Post-Procedure Administration of Interscalene Block in Arthroscopic Rotator Cuff Repair: Effects on Early Pain Control and Functional Outcomes
This study is evaluating whether the timing of an interscalene nerve block affects pain control and recovery after arthroscopic rotator cuff repair surgery.
An interscalene block is commonly used to reduce pain after shoulder surgery. However, it is not known whether administering the block before surgery or after surgery provides better outcomes. Participants undergoing arthroscopic rotator cuff repair are assigned to receive the interscalene block either before the surgical incision or after completion of the procedure.
Read more
The study compares postoperative pain levels, opioid medication use, length of hospital stay, and ultrasound imaging quality during block administration between the two groups. Functional recovery is also assessed using patient-reported outcome measures during follow-up.
The investigators hypothesize that administration of the interscalene block before surgery may provide superior early pain control and reduce postoperative opioid requirements while maintaining similar functional outcomes compared with administration after surgery.
Read the detailed description
Postoperative pain remains a major challenge following arthroscopic rotator cuff repair despite advances in multimodal analgesia protocols. Inadequate pain control may delay rehabilitation, increase opioid consumption, prolong hospitalization, and negatively affect patient satisfaction. Ultrasound-guided interscalene block has become a cornerstone of perioperative pain management for shoulder surgery because of its proven analgesic efficacy and favorable safety profile.
Although interscalene block is routinely used in clinical practice, the optimal timing of administration remains controversial. Administration before surgical incision may provide preemptive analgesic effects by attenuating central sensitization and reducing nociceptive input during surgery. In contrast, administration after completion of surgery has been proposed as a strategy to extend the duration of postoperative analgesia. Existing literature provides limited and inconsistent evidence regarding the comparative clinical benefits of these approaches in patients undergoing arthroscopic rotator cuff repair.
This study was designed to evaluate the impact of interscalene block timing within a contemporary shoulder surgery pathway. In addition to its potential influence on perioperative analgesia, the timing of block administration may affect procedural workflow and ultrasound visualization of relevant anatomical structures. Improved understanding of these factors may contribute to optimization of perioperative management strategies and support evidence-based recommendations for regional anesthesia practices in arthroscopic shoulder surgery.
- Keywords
- Rotator Cuff Tears, Arthroscopic Rotator Cuff Repair, Interscalene Nerve Block, Regional Anesthesia, Postoperative Pain, Preemptive Analgesia, Pain Management
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Procedure Interscalene Block | Participants undergoing arthroscopic rotator cuff repair who received an ultrasound-guided interscalene nerve block before surgical incision as part of the perioperative analgesia protocol. | |
| Post-Procedure Interscalene Block | Participants undergoing arthroscopic rotator cuff repair who received an ultrasound-guided interscalene nerve block after completion of surgery as part of the perioperative analgesia protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Pain Intensity
Patients' postoperative pain intensity measured using the Visual Analog Scale (VAS) following arthroscopic rotator cuff repair. Pain scores will be compared between pre-procedure and post-procedure interscalene block groups. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
Measured: Pre-procedure, postoperative 6th, 12th, 24th hours
Secondary outcomes (6)
Postoperative Opioid Consumption
Total opioid consumption recorded during the first postoperative 24 hours.
Measured: 24 hours after surgery
Patient-Controlled Analgesia Usage
Number of patient-controlled analgesia (PCA) bolus demands during the postoperative period.
Measured: 24 hours after surgery
Duration of hospitalization following arthroscopic rotator cuff repair.
Duration of hospitalization following arthroscopic rotator cuff repair.
Measured: From surgery until hospital discharge
Ultrasound Image Quality During Interscalene Block Administration
Quality of ultrasound visualization of the interscalene region assessed by the performing anesthesiologist using a 5-point Likert scale.
Measured: At the time of interscalene block administration
Oxford Shoulder Score
Functional shoulder outcome assessed using the Oxford Shoulder Score questionnaire. The Oxford Shoulder Score ranges from 0 to 48, with higher scores indicating better shoulder function.
Measured: Baseline, 3 months, and 6 months after surgery
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Upper extremity functional outcome assessed using the DASH questionnaire. The score ranges from 0 to 100, with higher scores indicating greater disability and worse upper extremity function.
Measured: Baseline, 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start13 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear RepairStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali S. Kavaklı, Professor, Study chair, Istinye UniversityOnur Senyurt, MD, Principal investigator, Istinye UniversityKaya Turan, MD, Assoc Prof, Study director, Istinye UniversityTaylan Sahin, MD, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689448
- Sponsor's protocol ID
- ISB-ARCR-2026
- Acronym
- ISB-ARCR
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because of institutional and ethical restrictions related to participant confidentiality and privacy protection.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Procedure Versus Post-Procedure Administration of Interscalene Block in Arthroscopic Rotator Cuff Repair: Effects on Early Pain Control and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07689448
- Acronym / sponsor ID
- ISB-ARCR / ISB-ARCR-2026
- Keywords
- Rotator Cuff Tears, Arthroscopic Rotator Cuff Repair, Interscalene Nerve Block, Regional Anesthesia, Postoperative Pain, Preemptive Analgesia, Pain Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 13 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 8 Jul 2026 (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 study is evaluating whether the timing of an interscalene nerve block affects pain control and recovery after arthroscopic rotator cuff repair surgery.
An interscalene block is commonly used to reduce pain after shoulder surgery. However, it is not known whether administering the block before surgery or after surgery provides better outcomes. Participants undergoing arthroscopic rotator cuff repair are assigned to receive the interscalene block either before the surgical incision or after completion of the procedure.
The study compares postoperative pain levels, opioid medication use, length of hospital stay, and ultrasound imaging quality during block administration between the two groups. Functional recovery is also assessed using patient-reported outcome measures during follow-up.
The investigators hypothesize that administration of the interscalene block before surgery may provide superior early pain control and reduce postoperative opioid requirements while maintaining similar functional outcomes compared with administration after surgery.
Detailed description
Postoperative pain remains a major challenge following arthroscopic rotator cuff repair despite advances in multimodal analgesia protocols. Inadequate pain control may delay rehabilitation, increase opioid consumption, prolong hospitalization, and negatively affect patient satisfaction. Ultrasound-guided interscalene block has become a cornerstone of perioperative pain management for shoulder surgery because of its proven analgesic efficacy and favorable safety profile.
Although interscalene block is routinely used in clinical practice, the optimal timing of administration remains controversial. Administration before surgical incision may provide preemptive analgesic effects by attenuating central sensitization and reducing nociceptive input during surgery. In contrast, administration after completion of surgery has been proposed as a strategy to extend the duration of postoperative analgesia. Existing literature provides limited and inconsistent evidence regarding the comparative clinical benefits of these approaches in patients undergoing arthroscopic rotator cuff repair.
This study was designed to evaluate the impact of interscalene block timing within a contemporary shoulder surgery pathway. In addition to its potential influence on perioperative analgesia, the timing of block administration may affect procedural workflow and ultrasound visualization of relevant anatomical structures. Improved understanding of these factors may contribute to optimization of perioperative management strategies and support evidence-based recommendations for regional anesthesia practices in arthroscopic shoulder surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Procedure Interscalene Block | – | –Participants undergoing arthroscopic rotator cuff repair who received an ultrasound-guided interscalene nerve block before surgical incision as part of the perioperative analgesia protocol. |
| Post-Procedure Interscalene Block | – | –Participants undergoing arthroscopic rotator cuff repair who received an ultrasound-guided interscalene nerve block after completion of surgery as part of the perioperative analgesia protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing primary arthroscopic rotator cuff repair for repairable rotator cuff tears at a single tertiary referral center. Participants received ultrasound-guided interscalene nerve block either before surgical incision or after completion of surgery according to routine perioperative practice.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Patients undergoing primary arthroscopic rotator cuff repair.
- Presence of a repairable small-, medium-, or large-sized rotator cuff tear confirmed by clinical and imaging evaluation.
- Receipt of an ultrasound-guided interscalene nerve block as part of perioperative pain management.
- Ability to provide informed consent and comply with study follow-up requirements.
Key exclusion criteria (9 listed)
- Irreparable rotator cuff tears.
- Partial-thickness rotator cuff tears not requiring repair.
- Revision rotator cuff repair procedures.
- Concomitant shoulder procedures that could substantially influence postoperative pain or functional outcomes (e.g., shoulder arthroplasty, fracture fixation).
- Previous surgery on the affected shoulder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Postoperative Pain Intensity
Time frame: Pre-procedure, postoperative 6th, 12th, 24th hours
Patients' postoperative pain intensity measured using the Visual Analog Scale (VAS) following arthroscopic rotator cuff repair. Pain scores will be compared between pre-procedure and post-procedure interscalene block groups. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
6 secondary outcomes
Postoperative Opioid Consumption
Time frame: 24 hours after surgery
Patient-Controlled Analgesia Usage
Time frame: 24 hours after surgery
Duration of hospitalization following arthroscopic rotator cuff repair.
Time frame: From surgery until hospital discharge
Ultrasound Image Quality During Interscalene Block Administration
Time frame: At the time of interscalene block administration
Oxford Shoulder Score
Time frame: Baseline, 3 months, and 6 months after surgery
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: Baseline, 3 months, and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because of institutional and ethical restrictions related to participant confidentiality and privacy protection.
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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.
Ali S. Kavaklı, Professor study chair
Istinye University
Onur Senyurt, MD principal investigator
Istinye University
Kaya Turan, MD, Assoc Prof study director
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear Repair and Interscalene Blocks, run by Istinye 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaya Turan, MD, FEBOT, Assoc Prof. (+905332937927, kaya.turan@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Postoperative Pain Intensity (time frame: Pre-procedure, postoperative 6th, 12th, 24th hours). 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 8 Jul 2026.