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

2026년 7월 9일 업데이트: Hansol Kim, MD, Seoul National University Hospital

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

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.

연구 개요

상태

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정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

92

단계

  • 4단계

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연구 연락처

연구 연락처 백업

  • 이름: Hwan Suk Jang, M.D.
  • 전화번호: +82-2-2072-2467
  • 이메일: j4n6h5@gmail.com

연구 장소

  • 대한민국
    • Jongno-gu
      • Seoul, Jongno-gu, 대한민국, 03080
        • Seoul National University Hospital
        • 연락하다:
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참여기준

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자격 기준

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설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Single-shot block with IV dexamethasone
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).
의약품: 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.
절차: 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.
활성 비교기: Continuous interscalene brachial plexus block
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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Rebound Pain Score (RPS)
기간: 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.
Within 24 hours after the nerve block

2차 결과 측정

결과 측정
측정값 설명
기간
Postoperative pain score (NRS)
기간: 4, 8, 12, 24, and 48 hours after surgery
Pain intensity at rest and during movement, measured on an 11-point NRS (0 = no pain, 10 = worst pain imaginable).
4, 8, 12, 24, and 48 hours after surgery
Peak NRS pain score
기간: 0-24 hours and 24-48 hours after surgery
Highest pain score reported during each period, on an 11-point NRS.
0-24 hours and 24-48 hours after surgery
Incidence of severe rebound pain
기간: Within 24 hours after the nerve block
Proportion of participants experiencing rebound pain with NRS ≥ 7.
Within 24 hours after the nerve block
Block duration
기간: Up to 48 hours after the nerve block
Time from completion of the nerve block to the first onset of pain.
Up to 48 hours after the nerve block
Time to first rescue analgesic
기간: Up to 48 hours after surgery
Time from the end of surgery to the first administration of rescue analgesics.
Up to 48 hours after surgery
Cumulative opioid consumption
기간: 24 and 48 hours after surgery
Cumulative opioid consumption converted to oral morphine equivalents (OME), including PCA use and rescue opioids.
24 and 48 hours after surgery
Block performance time
기간: During the block procedure (day of surgery)
Single-shot group: time from donning gloves to needle removal. Continuous group: time from donning gloves to completion of aseptic dressing.
During the block procedure (day of surgery)
Block failure rate
기간: From block completion to start of surgery (day of surgery)
Proportion of participants with inadequate sensory/motor block on arrival in the operating room requiring rescue block.
From block completion to start of surgery (day of surgery)
Rescue block administration
기간: Day of surgery
Proportion of participants requiring an additional rescue block (0.75% ropivacaine 5-10 mL).
Day of surgery
Intraoperative rescue analgesic use
기간: During surgery
Proportion of participants requiring intraoperative rescue analgesics (IV fentanyl 50-100 μg).
During surgery
Conversion to general anesthesia
기간: During surgery
Proportion of participants requiring conversion to general anesthesia due to inadequate block or uncontrolled pain.
During surgery
Intraoperative sedative consumption
기간: During surgery
Total dose of propofol administered for sedation during surgery.
During surgery
Quality of Recovery-15 Korean version (QoR-15K) score
기간: Baseline (day before surgery) and 24 hours after surgery
Quality of recovery assessed using the QoR-15K questionnaire (score range 0-150; higher scores indicate better recovery).
Baseline (day before surgery) and 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
기간: 4, 8, 12, 24, and 48 hours after surgery
Proportion of participants experiencing PONV and requiring antiemetics.
4, 8, 12, 24, and 48 hours after surgery
Length of hospital stay
기간: From surgery to discharge, up to 30 days
Duration of hospitalization from surgery to discharge.
From surgery to discharge, up to 30 days
Patient satisfaction
기간: 48 hours after surgery
Numerical rating scale satisfaction score. 0, not satisfied; 10, absolutely satisfied.
48 hours after surgery
Incidence of hemidiaphragmatic paralysis
기간: Within 24 hours after the nerve block
Proportion of participants with phrenic nerve palsy after the block.
Within 24 hours after the nerve block
Postoperative blood glucose change
기간: Postoperative day 1
Change in blood glucose level on postoperative day 1 compared with baseline.
Postoperative day 1
Incidence of surgical and anesthetic complications
기간: Up to 30 days after surgery
Surgical complications (surgical site infection, delayed wound healing) and anesthesia-related complications (nerve injury, local anesthetic systemic toxicity, catheter-related problems such as dislodgement, leakage, or infection).
Up to 30 days after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Seoul National University Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 15일

기본 완료 (추정된)

2027년 6월 15일

연구 완료 (추정된)

2027년 7월 15일

연구 등록 날짜

최초 제출

2026년 7월 5일

QC 기준을 충족하는 최초 제출

2026년 7월 9일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 9일

마지막으로 확인됨

2026년 7월 1일

추가 정보

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2605-154-1749

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Individual participant data will not be shared because the informed consent obtained from participants does not include provisions for data sharing with third parties.

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