Ireland
--:--IST
Recruiting Phase 4

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

NCT07699744 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2026-08-25
Last updated
2026-09-29

Condition(s) studied

Pain, PostoperativeRebound PainShoulder InjuriesRotator Cuff Injuries

Investigational drug(s) / intervention(s)

Dexamethasone (IV) →Single-shot interscalene brachial plexus blockContinuous interscalene brachial plexus block

Dexamethasone (IV): 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 interscalene brachial plexus block: 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.

Continuous interscalene brachial plexus block: 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.

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: * Adult patients aged 19 to 79 years scheduled for elective shoulder surgery under brachial plexus block and monitored anesthesia care (MAC) Exclusion Criteria: * 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

Primary outcome measure(s)

  • Rebound Pain Score (RPS) — Within 24 hours after the nerve block
    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.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Jongno-gu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07699744 on ClinicalTrials.gov ↗ ← All trials in South Korea