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

9 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

92

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Hwan Suk Jang, M.D.
  • Numero di telefono: +82-2-2072-2467
  • Email: j4n6h5@gmail.com

Luoghi di studio

  • Corea del Sud
    • Jongno-gu
      • Seoul, Jongno-gu, Corea del Sud, 03080
        • Seoul National University Hospital
        • Contatto:
        • Contatto:
          • Hwan Suk Jang, M.D.
          • Numero di telefono: +82-2-2072-2467
          • Email: j4n6h5@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Droga: 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.
Procedura: 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.
Comparatore attivo: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rebound Pain Score (RPS)
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Seoul National University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

15 giugno 2027

Completamento dello studio (Stimato)

15 luglio 2027

Date di iscrizione allo studio

Primo inviato

5 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2605-154-1749

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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