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

9. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

92

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Hwan Suk Jang, M.D.
  • Telefonnummer: +82-2-2072-2467
  • E-post: j4n6h5@gmail.com

Studiesteder

  • Sør -Korea
    • Jongno-gu
      • Seoul, Jongno-gu, Sør -Korea, 03080
        • Seoul National University Hospital
        • Ta kontakt med:
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: 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.
Fremgangsmåte: 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.
Aktiv komparator: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rebound Pain Score (RPS)
Tidsramme: 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

Sekundære resultatmål

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

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Sponsor

Seoul National University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juli 2026

Primær fullføring (Antatt)

15. juni 2027

Studiet fullført (Antatt)

15. juli 2027

Datoer for studieregistrering

Først innsendt

5. juli 2026

Først innsendt som oppfylte QC-kriteriene

9. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2605-154-1749

Plan for individuelle deltakerdata (IPD)

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NEI

IPD-planbeskrivelse

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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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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