Regional Anesthesia Techniques in Shoulder SurgeryBLOCK-SHOULDERNCT07173894
Effectiveness of Field Block Compared With Interscalene Block in Shoulder Surgery
A study testing Shoulder Field Block by Orthopedic Surgeon and Interscalene brachial plexus block and superficial cervical plexus block in people with Regional Anesthesia Techniques in Shoulder Surgery, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This study will compare two different types of anesthesia used for shoulder surgery. The first method, called an interscalene block, is commonly performed by anesthesiologists and is effective for pain control but may cause side effects such as breathing problems, arm weakness, or discomfort. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Regional Anesthesia Techniques in Shoulder Surgery
- What is being tested?
- Shoulder Field Block by Orthopedic Surgeon and Interscalene brachial plexus block and superficial cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2024to 1 Jan 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Scheduled for arthroscopic or open shoulder surgery
Who cannot join
- Prior surgery or trauma to the shoulder
- Revision shoulder surgery
- Fibromyalgia
- Pregnancy
- Contraindications to regional anesthesia (e.g., allergy to local anesthetics, coagulopathy, local site infection)
- Preexisting neuropathy or myopathy of the surgical limb
- History of chronic opioid use
- Cognitive impairment or inability to understand pain scoring systems (e.g., dementia)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin medical center- Hasharon hospital
Petah Tikva, Central District, 49372
About this study
Official title: Randomized Control Study: The Effectiveness of Field Block (Local Anesthesia) Compared With Interscalene Block in Shoulder Surgery
This study will compare two different types of anesthesia used for shoulder surgery. The first method, called an interscalene block, is commonly performed by anesthesiologists and is effective for pain control but may cause side effects such as breathing problems, arm weakness, or discomfort. The second method, called a shoulder field block, is a newer technique performed by orthopedic surgeons that numbs the nerves around the shoulder without affecting breathing.
Patients scheduled for shoulder surgery will be randomly assigned to receive either the interscalene block or the shoulder field block. The main goal of the study is to find out whether the shoulder field block provides pain relief that is as effective as the interscalene block, but with fewer side effects.
Pain levels, patient satisfaction, length of hospital stay, need for pain medication, and any complications will be recorded and compared between the two groups. The results may help identify a safe and effective alternative anesthesia option for patients undergoing shoulder surgery.
Read the detailed description
Regional anesthesia is widely used for shoulder surgery, most commonly with an interscalene brachial plexus block (ISB). While ISB provides effective pain relief, it is associated with side effects such as hemidiaphragmatic paralysis, breathing difficulties, Horner's syndrome, nerve injury, and rebound pain. These risks limit its use in patients with respiratory conditions, obesity, or other contraindications.
A shoulder field block (FB) is a newer approach that targets the suprascapular, axillary, and lateral pectoral nerves, which supply most of the sensation to the shoulder joint. Unlike ISB, the field block does not affect the phrenic nerve, making it a potentially safer option. Cadaveric and early clinical studies suggest that field blocks may provide effective pain relief with fewer complications, but direct comparisons with ISB in surgical patients are limited.
This randomized controlled trial will enroll 64 adult patients undergoing arthroscopic or open shoulder surgery. Patients will be randomized into two groups:
Field Block Group: Local anesthesia field block performed by an orthopedic surgeon using anatomical landmarks.
Interscalene Block Group: Standard interscalene block performed by an anesthesiologist.
The primary outcome will be postoperative pain intensity measured by a numerical rating scale (0-10) at multiple time points during the first 48 hours. Secondary outcomes include patient satisfaction, hospital length of stay, opioid consumption, complications, and unplanned medical visits due to pain.
The study hypothesis is that a shoulder field block will provide pain relief that is non-inferior to an interscalene block, while reducing side effects and improving patient satisfaction. If effective, this technique could offer a practical alternative that can be safely performed by orthopedic surgeons, expanding anesthesia options for shoulder surgery patients.
- Being tested
- Shoulder Field Block by Orthopedic Surgeon, Interscalene brachial plexus block and superficial cervical plexus block
- Keywords
- Shoulder Surgery, Open Shoulder Surgery, Postoperative Pain, Pain Management, Regional Anesthesia, Interscalene Block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder Field Block by Orthopedic SurgeonProcedure or surgery
For Shoulder Field Block intervention:
This intervention involves a regional anesthesia technique targeting the sensory nerves of the shoulder surgical field: the suprascapular, axillary, and lateral pectoral nerves. The block is performed intraoperatively by the orthopedic surgeon using anatomical landmarks after induction of general anesthesia. A mixture of lidocaine with epinephrine, bupivacaine, and saline is injected into the shoulder area to provide local anesthesia and prolonged postoperative analgesia. This technique aims to spare the phrenic nerve, potentially reducing respiratory complications associated with traditional blocks.
Interscalene brachial plexus block and superficial cervical plexus blockProcedure or surgery
This intervention involves a standard interscalene brachial plexus block performed preoperatively by an anesthesiologist under ultrasound guidance. It anesthetizes the upper roots (C5-C7) of the brachial plexus to provide effective analgesia for shoulder surgery. While effective, it carries risks such as hemi-diaphragmatic paralysis, Horner's syndrome, and motor weakness of the ipsilateral arm due to spread to adjacent nerves.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Field Block by Orthopedic Surgeon | Experimental | Participants in this arm will receive a shoulder field block performed by the orthopedic surgeon using anatomical landmarks after induction of general anesthesia. The block targets the suprascapular, axillary, and lateral pectoral nerves using a tumescent local anesthetic mixture of lidocaine with epinephrine, bupivacaine, and saline to provide intraoperative and postoperative analgesia. This novel technique aims to provide effective pain relief with fewer side effects compared to the standard interscalene brachial plexus block. Receives: Procedure: Shoulder Field Block by Orthopedic Surgeon |
| Interscalene Block by Anesthesiologist | Active comparator | Participants in this arm will receive a standard interscalene brachial plexus block performed by an anesthesiologist under ultrasound guidance before surgery. This block anesthetizes the upper brachial plexus nerves to provide effective intraoperative and postoperative analgesia for shoulder surgery. It is the current standard of care but may be associated with side effects such as diaphragmatic paralysis and arm weakness. Receives: Procedure: Interscalene brachial plexus block and superficial cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured by Numerical Rating Scale (NRS)
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst pain imaginable. Measurements will be taken at 1 hour postoperatively in the Post-Anesthesia Care Unit (PACU), at discharge from PACU, and at 6, 12, 24, and 48 hours after surgery. This outcome evaluates the effectiveness of the Shoulder Field Block compared to the Interscalene Block in controlling postoperative pain.
Measured: From 1 hour postoperative until 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Aug 2024
- Primary completion1 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia Techniques in Shoulder SurgeryStudies 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 comparative study designed to evaluate the effectiveness and safety of a novel Shoulder Field Block (SFB) technique performed by an orthopedic surgeon versus the standard Interscalene Brachial Plexus Block (ISB) performed by an anesthesiologist in patients undergoing shoulder surgery. Patients will be randomized in a 1:1 ratio to receive either the SFB or ISB technique prior to surgery. The field block is performed intraoperatively after general anesthesia using anatomical landmarks, whereas ISB is performed preoperatively using ultrasound guidance. Both groups will receive the same general anesthetic protocol and standardized multimodal perioperative analgesia. Pain scores, opioid use, complications, and satisfaction will be assessed over a 48-hour postoperative period. The study aims to assess whether the field block is non-inferior to ISB in terms of pain control while offering potential advantages such as fewer complications
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERAS QAWASMI, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173894
- Sponsor's protocol ID
- HASH-ORTHO-FBvsISB-2025
- Acronym
- BLOCK-SHOULDER
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the article, including data tables, will be shared. This includes pain scores (NRS), opioid consumption, complication rates, and patient satisfaction scores.
Publications
Auyong DB, Hanson NA, Joseph RS, Schmidt BE, Slee AE, Yuan SC. Comparison of Anterior Suprascapular, Supraclavicular, and Interscalene Nerve Block Approaches for Major Outpatient Arthroscopic Shoulder Surgery: A Randomized, Double-blind, Noninferiority Trial. Anesthesiology. 2018 Jul;129(1):47-57. doi: 10.1097/ALN.0000000000002208.
PubMed 29634491
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study: The Effectiveness of Field Block (Local Anesthesia) Compared With Interscalene Block in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07173894
- Acronym / sponsor ID
- BLOCK-SHOULDER / HASH-ORTHO-FBvsISB-2025
- Keywords
- Shoulder Surgery, Open Shoulder Surgery, Postoperative Pain, Pain Management, Regional Anesthesia, Interscalene Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 15 Sep 2025 (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 will compare two different types of anesthesia used for shoulder surgery. The first method, called an interscalene block, is commonly performed by anesthesiologists and is effective for pain control but may cause side effects such as breathing problems, arm weakness, or discomfort. The second method, called a shoulder field block, is a newer technique performed by orthopedic surgeons that numbs the nerves around the shoulder without affecting breathing.
Patients scheduled for shoulder surgery will be randomly assigned to receive either the interscalene block or the shoulder field block. The main goal of the study is to find out whether the shoulder field block provides pain relief that is as effective as the interscalene block, but with fewer side effects.
Pain levels, patient satisfaction, length of hospital stay, need for pain medication, and any complications will be recorded and compared between the two groups. The results may help identify a safe and effective alternative anesthesia option for patients undergoing shoulder surgery.
Detailed description
Regional anesthesia is widely used for shoulder surgery, most commonly with an interscalene brachial plexus block (ISB). While ISB provides effective pain relief, it is associated with side effects such as hemidiaphragmatic paralysis, breathing difficulties, Horner's syndrome, nerve injury, and rebound pain. These risks limit its use in patients with respiratory conditions, obesity, or other contraindications.
A shoulder field block (FB) is a newer approach that targets the suprascapular, axillary, and lateral pectoral nerves, which supply most of the sensation to the shoulder joint. Unlike ISB, the field block does not affect the phrenic nerve, making it a potentially safer option. Cadaveric and early clinical studies suggest that field blocks may provide effective pain relief with fewer complications, but direct comparisons with ISB in surgical patients are limited.
This randomized controlled trial will enroll 64 adult patients undergoing arthroscopic or open shoulder surgery. Patients will be randomized into two groups:
Field Block Group: Local anesthesia field block performed by an orthopedic surgeon using anatomical landmarks.
Interscalene Block Group: Standard interscalene block performed by an anesthesiologist.
The primary outcome will be postoperative pain intensity measured by a numerical rating scale (0-10) at multiple time points during the first 48 hours. Secondary outcomes include patient satisfaction, hospital length of stay, opioid consumption, complications, and unplanned medical visits due to pain.
The study hypothesis is that a shoulder field block will provide pain relief that is non-inferior to an interscalene block, while reducing side effects and improving patient satisfaction. If effective, this technique could offer a practical alternative that can be safely performed by orthopedic surgeons, expanding anesthesia options for shoulder surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, parallel-group comparative study designed to evaluate the effectiveness and safety of a novel Shoulder Field Block (SFB) technique performed by an orthopedic surgeon versus the standard Interscalene Brachial Plexus Block (ISB) performed by an anesthesiologist in patients undergoing shoulder surgery. Patients will be randomized in a 1:1 ratio to receive either the SFB or ISB technique prior to surgery. The field block is performed intraoperatively after general anesthesia using anatomical landmarks, whereas ISB is performed preoperatively using ultrasound guidance. Both groups will receive the same general anesthetic protocol and standardized multimodal perioperative analgesia. Pain scores, opioid use, complications, and satisfaction will be assessed over a 48-hour postoperative period. The study aims to assess whether the field block is non-inferior to ISB in terms of pain control while offering potential advantages such as fewer complications
| Arm | Type | Receives |
|---|---|---|
| Shoulder Field Block by Orthopedic Surgeon | Experimental | Procedure: Shoulder Field Block by Orthopedic SurgeonParticipants in this arm will receive a shoulder field block performed by the orthopedic surgeon using anatomical landmarks after induction of general anesthesia. The block targets the suprascapular, axillary, and lateral pectoral nerves using a tumescent local anesthetic mixture of lidocaine with epinephrine, bupivacaine, and saline to provide intraoperative and postoperative analgesia. This novel technique aims to provide effective pain relief with fewer side effects compared to the standard interscalene brachial plexus block. |
| Interscalene Block by Anesthesiologist | Active comparator | Procedure: Interscalene brachial plexus block and superficial cervical plexus blockParticipants in this arm will receive a standard interscalene brachial plexus block performed by an anesthesiologist under ultrasound guidance before surgery. This block anesthetizes the upper brachial plexus nerves to provide effective intraoperative and postoperative analgesia for shoulder surgery. It is the current standard of care but may be associated with side effects such as diaphragmatic paralysis and arm weakness. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 75 years
- Scheduled for arthroscopic or open shoulder surgery
Key exclusion criteria (8 listed)
- Prior surgery or trauma to the shoulder
- Revision shoulder surgery
- Fibromyalgia
- Pregnancy
- Contraindications to regional anesthesia (e.g., allergy to local anesthetics, coagulopathy, local site infection)
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 |
|---|---|---|
| Shoulder Field Block by Orthopedic SurgeonFor Shoulder Field Block intervention: This intervention involves a regional anesthesia technique targeting the sensory nerves of the shoulder surgical field: the suprascapular, axillary, and lateral pectoral nerves. The block is performed intraoperatively by the orthopedic surgeon using anatomical landmarks after induction of general anesthesia. A mixture of lidocaine with epinephrine, bupivacaine, and saline is injected into the shoulder area to provide local anesthesia and prolonged postoperative analgesia. This technique aims to spare the phrenic nerve, potentially reducing respiratory complications associated with traditional blocks. | Procedure or surgery | Shoulder Field Block by Orthopedic Surgeon |
| Interscalene brachial plexus block and superficial cervical plexus blockThis intervention involves a standard interscalene brachial plexus block performed preoperatively by an anesthesiologist under ultrasound guidance. It anesthetizes the upper roots (C5-C7) of the brachial plexus to provide effective analgesia for shoulder surgery. While effective, it carries risks such as hemi-diaphragmatic paralysis, Horner's syndrome, and motor weakness of the ipsilateral arm due to spread to adjacent nerves. | Procedure or surgery | Interscalene Block by Anesthesiologist |
Primary outcome
Postoperative pain intensity measured by Numerical Rating Scale (NRS)
Time frame: From 1 hour postoperative until 48 hours after surgery
Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst pain imaginable. Measurements will be taken at 1 hour postoperatively in the Post-Anesthesia Care Unit (PACU), at discharge from PACU, and at 6, 12, 24, and 48 hours after surgery. This outcome evaluates the effectiveness of the Shoulder Field Block compared to the Interscalene Block in controlling postoperative pain.
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 17 Jun 2026.
- Background: PubMed 29634491Auyong DB, Hanson NA, Joseph RS, Schmidt BE, Slee AE, Yuan SC. Comparison of Anterior Suprascapular, Supraclavicular, and Interscalene Nerve Block Approaches for Major Outpatient Arthroscopic Shoulder Surgery: A Randomized, Double-blind, Noninferiority Trial. Anesthesiology. 2018 Jul;129(1):47-57. doi: 10.1097/ALN.0000000000002208.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the article, including data tables, will be shared. This includes pain scores (NRS), opioid consumption, complication rates, and patient satisfaction scores.
Related trials for Regional Anesthesia Techniques in Shoulder Surgery
RecruitingObservational study
The Effects of Regional Anaesthesia Techniques on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores
Regional Anaesthesia, Arthroscopic Shoulder Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Field Block by Orthopedic Surgeon and Interscalene brachial plexus block and superficial cervical plexus block in people with Regional Anesthesia Techniques in Shoulder Surgery, run by Rabin Medical Center at 1 site in Israel.
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 2 inclusion and 8 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 17 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 Israel. 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?
Postoperative pain intensity measured by Numerical Rating Scale (NRS) (time frame: From 1 hour postoperative until 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173894, which also lists 1 linked publication.
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 17 Jun 2026.