Effectiveness of Field Block Compared With Interscalene Block in Shoulder Surgery

NCT07173894 | Recruiting

• 1 other identifier: HASH-ORTHO-FBvsISB-2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Regional Anesthesia Techniques in Shoulder Surgery

Keywords

Shoulder Surgery, Open Shoulder Surgery, Postoperative Pain, Pain Management, Regional Anesthesia, Interscalene Block

Outcome Measures

Primary Outcomes (1)

• 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.

  From 1 hour postoperative until 48 hours after surgery

Study Arms (2)

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.

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.

Procedure: Interscalene brachial plexus block and superficial cervical plexus block

Interventions

Shoulder Field Block by Orthopedic Surgeon PROCEDURE

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.

Shoulder Field Block by Orthopedic Surgeon

Interscalene brachial plexus block and superficial cervical plexus block PROCEDURE

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.

Interscalene Block by Anesthesiologist

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Scheduled for arthroscopic or open shoulder surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin medical center- Hasharon hospital

Petah Tikva, Central District, 49372, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 29634491 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Feras Qawasmi, MD

CONTACT

+972546149298; ferasport@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon, Department of Orthopedic Surgery, Hasharon Hospital, Rabin Medical Center

Model Details: 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

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: August 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documentation will be available beginning 6 months after publication and will remain available for up to 3 years following the publication date.
• Access Criteria: Qualified researchers with a methodologically sound proposal may request access to the data. Requests should be submitted to the principal investigator via institutional email. Data will be provided through a secure data-sharing platform, after approval of a data use agreement.

Locations

IL (1)