Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

9 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

92

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Hwan Suk Jang, M.D.
  • Telefoonnummer: +82-2-2072-2467
  • E-mail: j4n6h5@gmail.com

Studie Locaties

  • Zuid -Korea
    • Jongno-gu
      • Seoul, Jongno-gu, Zuid -Korea, 03080
        • Seoul National University Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Geneesmiddel: 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.
Procedure: 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.
Actieve vergelijker: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rebound Pain Score (RPS)
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seoul National University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juli 2026

Primaire voltooiing (Geschat)

15 juni 2027

Studie voltooiing (Geschat)

15 juli 2027

Studieregistratiedata

Eerst ingediend

5 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2605-154-1749

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren