Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery

NCT07699744 | Not Yet Recruiting Phase 4

• 1 other identifier: 2605-154-1749
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder surgery often causes severe pain after the operation. To control this pain, doctors commonly perform a nerve block (interscalene brachial plexus block), which numbs the shoulder area. However, when the effect of a single-injection nerve block wears off, many patients experience sudden, intense pain known as "rebound pain". One way to prevent rebound pain is to place a thin catheter near the nerves so that local anesthetic can be given continuously for a longer period (continuous nerve block). However, this method is technically demanding and can cause problems such as catheter dislodgement, infection, and inconvenience for patients. Another simpler option is to give a single-injection nerve block together with an intravenous (IV) injection of dexamethasone, a steroid medication known to prolong the effect of nerve blocks and reduce rebound pain. The purpose of this study is to determine whether a single-injection nerve block combined with IV dexamethasone (5 mg) is not inferior to a continuous nerve block in preventing rebound pain after shoulder surgery. A total of 92 adult patients scheduled for elective shoulder surgery will be randomly assigned to one of the two groups. The main outcome is the rebound pain score, defined as the difference between the last pain score recorded in the recovery room (while the nerve block is still working) and the highest pain score reported within the first 24 hours after the nerve block. The investigators expect that the simpler single-injection method with IV dexamethasone will provide comparable pain control while avoiding the complications and inconvenience of catheter-based continuous nerve blocks.

Conditions

Pain, Postoperative; Rebound Pain; Shoulder Injuries; Rotator Cuff Injuries

Keywords

Rebound pain; Interscalene brachial plexus block; Single-shot nerve block; Continuous peripheral nerve block; Perineural catheter; Dexamethasone; Intravenous dexamethasone; Shoulder surgery; Rotator cuff repair; Regional anesthesia; Postoperative analgesia; Multimodal analgesia; Non-inferiority trial; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• Rebound Pain Score (RPS)

  Difference between the last pain score recorded in the post-anesthesia care unit (PACU) while the nerve block is still effective and the highest pain score reported within the first 24 hours after the nerve block, measured on an 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Higher scores indicate more severe rebound pain. Non-inferiority margin: 1.5.

  Within 24 hours after the nerve block

Secondary Outcomes (19)

• Postoperative pain score (NRS)

  4, 8, 12, 24, and 48 hours after surgery

• Peak NRS pain score

  0-24 hours and 24-48 hours after surgery

• Incidence of severe rebound pain

  Within 24 hours after the nerve block

• Block duration

  Up to 48 hours after the nerve block

• Time to first rescue analgesic

  Up to 48 hours after surgery

Study Arms (2)

Single-shot block with IV dexamethasone

EXPERIMENTAL

Participants receive a single-shot ultrasound-guided interscalene brachial plexus block with 0.75% ropivacaine 15-20 mL, followed by intravenous dexamethasone 5 mg administered after confirmation of successful block on arrival in the operating room. Postoperatively, an intravenous patient-controlled analgesia (PCA) pump with fentanyl (10 mcg/mL, bolus 1 mL, lockout 6 min, no basal rate) is connected. All participants receive standard multimodal analgesia (intravenous acetaminophen 1000 mg plus ibuprofen 300 mg every 8 hours).

Drug: Dexamethasone (IV); Procedure: Single-shot interscalene brachial plexus block

Continuous interscalene brachial plexus block

ACTIVE COMPARATOR

Participants receive an ultrasound-guided continuous interscalene brachial plexus block: 0.75% ropivacaine 15-20 mL is injected at the interscalene level, and a perineural catheter is placed with the tip adjacent to the superior trunk. Postoperatively, a nerve block PCA (0.2% ropivacaine, basal rate 5 mL/h, bolus 3 mL, lockout 30 min) is connected via the catheter. All participants receive the same standard multimodal analgesia as the experimental arm.

Procedure: Continuous interscalene brachial plexus block

Interventions

Dexamethasone (IV) DRUG

Intravenous dexamethasone 5 mg, administered as a single dose after confirmation of adequate sensory and motor block on arrival in the operating room.

Single-shot block with IV dexamethasone

Single-shot interscalene brachial plexus block PROCEDURE

Ultrasound-guided single-shot interscalene brachial plexus block performed with a 50 mm needle. 0.75% ropivacaine 15-20 mL is injected at the interscalene level. No perineural catheter is placed.

Single-shot block with IV dexamethasone

Continuous interscalene brachial plexus block PROCEDURE

Ultrasound-guided interscalene brachial plexus block with 0.75% ropivacaine 15-20 mL, followed by placement of a perineural catheter adjacent to the superior trunk. Continuous postoperative analgesia is provided through the catheter using 0.2% ropivacaine (basal rate 5 mL/h, bolus 3 mL, lockout time 30 min) via a patient-controlled analgesia pump.

Continuous interscalene brachial plexus block

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 19 to 79 years scheduled for elective shoulder surgery under brachial plexus block and monitored anesthesia care (MAC)

You may not qualify if:

• Pre-existing neurological deficit of the brachial plexus
• Emergency surgery
• American Society of Anesthesiologists (ASA) physical status classification IV or higher
• Contraindication or history of hypersensitivity to local anesthetics or dexamethasone
• Severe pulmonary disease (e.g., chronic obstructive pulmonary disease)
• Body mass index (BMI) ≥ 35 kg/m²
• Long-term use of steroids
• Long-term use of analgesics
• Inability to cooperate or communicate
• Pregnancy

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Injuries; Rotator Cuff Injuries

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries; Rupture; Tendon Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Hansol Kim, M.D.

CONTACT

+82-2-2072-2467; hansolfrkr@gmail.com

Hwan Suk Jang, M.D.

CONTACT

+82-2-2072-2467; j4n6h5@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention (presence or absence of a perineural catheter), participants, care providers, and outcomes assessors are not masked. The statistician performing the analysis will remain blinded to group allocation until the analysis is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Participants are randomly assigned in a 1:1 ratio to either single-shot interscalene brachial plexus block with intravenous dexamethasone 5 mg or continuous interscalene brachial plexus block. This is a non-inferiority trial.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 13, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)