このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年7月9日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

92

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Hwan Suk Jang, M.D.
  • 電話番号：+82-2-2072-2467
  • メール：j4n6h5@gmail.com

研究場所

  • 韓国
    • Jongno-gu
      • Seoul、Jongno-gu、韓国、03080
        • Seoul National University Hospital
        • コンタクト：
        • コンタクト：
          • Hwan Suk Jang, M.D.
          • 電話番号：+82-2-2072-2467
          • メール：j4n6h5@gmail.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：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.
手順：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.
アクティブコンパレータ：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.
手順：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Rebound Pain Score (RPS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Postoperative pain score (NRS)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Day of surgery
Proportion of participants requiring an additional rescue block (0.75% ropivacaine 5-10 mL).
Day of surgery
Intraoperative rescue analgesic use
時間枠：During surgery
Proportion of participants requiring intraoperative rescue analgesics (IV fentanyl 50-100 μg).
During surgery
Conversion to general anesthesia
時間枠：During surgery
Proportion of participants requiring conversion to general anesthesia due to inadequate block or uncontrolled pain.
During surgery
Intraoperative sedative consumption
時間枠：During surgery
Total dose of propofol administered for sedation during surgery.
During surgery
Quality of Recovery-15 Korean version (QoR-15K) score
時間枠：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)
時間枠：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
時間枠：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
時間枠：48 hours after surgery
Numerical rating scale satisfaction score. 0, not satisfied; 10, absolutely satisfied.
48 hours after surgery
Incidence of hemidiaphragmatic paralysis
時間枠：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
時間枠：Postoperative day 1
Change in blood glucose level on postoperative day 1 compared with baseline.
Postoperative day 1
Incidence of surgical and anesthetic complications
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Seoul National University Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月15日

一次修了 (推定)

2027年6月15日

研究の完了 (推定)

2027年7月15日

試験登録日

最初に提出

2026年7月5日

QC基準を満たした最初の提出物

2026年7月9日

最初の投稿 (実際)

2026年7月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月9日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2605-154-1749

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する