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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Rebound Pain Score (RPS) [Срок оценки: Within 24 hours after the nerve block]

Вторичные конечные точки (12)

• Postoperative pain score (NRS) [Срок оценки: 4, 8, 12, 24, and 48 hours after surgery]
• Peak NRS pain score [Срок оценки: 0-24 hours and 24-48 hours after surgery]
• Incidence of severe rebound pain [Срок оценки: Within 24 hours after the nerve block]
• Block duration [Срок оценки: Up to 48 hours after the nerve block]
• Time to first rescue analgesic [Срок оценки: Up to 48 hours after surgery]
• Cumulative opioid consumption [Срок оценки: 24 and 48 hours after surgery]
• Block performance time [Срок оценки: During the block procedure (day of surgery)]
• Block failure rate [Срок оценки: From block completion to start of surgery (day of surgery)]
• Rescue block administration [Срок оценки: Day of surgery]
• Intraoperative rescue analgesic use [Срок оценки: During surgery]
• Conversion to general anesthesia [Срок оценки: During surgery]
• Intraoperative sedative consumption [Срок оценки: During surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT07699744 · 2605-154-1749

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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