Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone (IV), Single-shot interscalene brachial plexus block, Continuous interscalene brachial plexus block.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Rebound Pain, Shoulder Injuries, Rotator Cuff Injuries. Basic parameters: 19 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pain Management Protocol Optimization for Rebound Pain Prevention and Enhanced Recovery After Shoulder Surgery: A Randomized Noninferiority Trial of Intravenous Dexamethasone Combined With Single-Shot Versus Continuous Brachial Plexus Block
Overview
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.
Interventions
- Drug 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. - Procedure 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. - Procedure 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.
Primary outcome measures
- Rebound Pain Score (RPS) [Time frame: Within 24 hours after the nerve block]
Secondary outcome measures (12)
- Postoperative pain score (NRS) [Time frame: 4, 8, 12, 24, and 48 hours after surgery]
- Peak NRS pain score [Time frame: 0-24 hours and 24-48 hours after surgery]
- Incidence of severe rebound pain [Time frame: Within 24 hours after the nerve block]
- Block duration [Time frame: Up to 48 hours after the nerve block]
- Time to first rescue analgesic [Time frame: Up to 48 hours after surgery]
- Cumulative opioid consumption [Time frame: 24 and 48 hours after surgery]
- Block performance time [Time frame: During the block procedure (day of surgery)]
- Block failure rate [Time frame: From block completion to start of surgery (day of surgery)]
- Rescue block administration [Time frame: Day of surgery]
- Intraoperative rescue analgesic use [Time frame: During surgery]
- Conversion to general anesthesia [Time frame: During surgery]
- Intraoperative sedative consumption [Time frame: During surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07699744 · 2605-154-1749