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The Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block.

19. maj 2026 opdateret af: Tao Xu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Liposomal Bupivacaine Combined With Plain Bupivacaine for Peripheral Nerve Block to Reduce Rebound Pain After Orthopedic Extremity Surgery: A Multicenter Randomized Controlled Trial

This study will prospectively compare the preventive effect of liposomal bupivacaine combined with plain bupivacaine versus plain bupivacaine alone on rebound pain after nerve block in patients undergoing orthopedic extremity surgery. The primary aim is to assess whether the combination reduces the incidence or severity of rebound pain (i.e., more effectively covers the postoperative inflammatory peak on days 2-3 and provides a smoother regression curve of sensory blockade). Secondary aims include evaluation of upper limb functional scores, occurrence of chronic pain, and health-related quality of life. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Rebound pain (RP) after nerve block occurs in up to 50% of patients, presenting as acute severe pain that impairs recovery and is associated with chronic pain. Risk factors include female sex, younger age, orthopedic surgery, and lack of perioperative dexamethasone use. Even with dexamethasone, approximately one-third of patients show a poor response, suggesting the limitations of a single-agent anti-inflammatory strategy.

RP is associated with an imbalance in perioperative inflammation management. The postoperative inflammatory peak occurs on days 2-3 and is accompanied by central sensitization, with pain rebounding after block resolution. Prolonged sensory blockade may reduce RP; however, continuous nerve block techniques are complex and associated with higher complication rates, which limits their clinical application.

Liposomal bupivacaine provides up to 72 hours of analgesia with a single injection, prolongs sensory blockade, and may theoretically reduce RP. Nevertheless, existing evidence is inconsistent: some studies support its efficacy, whereas others fail to demonstrate clinically important differences. Moreover, one animal study suggests that it may only delay, rather than eliminate, RP, albeit with limited evidence quality. This study aims to evaluate the preventive effect of liposomal bupivacaine combined with plain bupivacaine on RP after nerve block in orthopedic extremity surgery, thereby providing evidence to inform clinical strategies.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

668

Fase

  • Fase 4

Kontakter og lokationer

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Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200233
        • Shanghai Sixth People's Hospital

Deltagelseskriterier

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  • Ældre voksen

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Beskrivelse

Inclusion Criteria:

18-80 years old; ASA Physical Status 1-3; Scheduled for elective unilateral orthopedic surgery of the upper or lower extremity.

Exclusion Criteria:

Women who are pregnant or breastfeeding; Bupivacaine sensitivity or known allergy; Contraindication for nerve blocks; Enrollment in another clinical trial that could confound pain evaluation; Other conditions.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: liposomal bupivacaine
10 ml of plain bupivacaine 0.75% will be mixed with 10 ml liposomal bupivacaine (133mg)
Medicin: liposomal bupivacaine
Prepare a local anesthetic by combining liposomal bupivacaine (133 mg/10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 1:1 volume ratio.
Placebo komparator: normal saline
10 ml of plain bupivacaine 0.75% will be combined with 10 ml of normal saline
Medicin: Normal Saline
placebo (normal saline)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
incidence of rebound pain
Tidsramme: the first 24 hours after surgery
Rebound pain was defined as initial mild pain (<4/ 10) when the patient left the recovery room, progressing to severe pain (>7/10) (NRS, 0-10) occurring within the first 24 hours after the procedure.
the first 24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Return of Sensation
Tidsramme: 72 hours
Sensory recovery time is defined as the time (in hours) until ≥75% of the initially blocked test locations regain cold and pinprick sensation. Sensory recovery will be assessed using a combined patient-reported and investigator-verified approach. Every 2 hours, patients will self-report their sensory status using a three-point scale: 0 = completely numb, 1 = abnormal sensation, 2 = normal sensation. Investigators will verify patient reports twice daily (at 7:00 and 19:00) using ice and pinprick testing. This outcome, time to sensory recovery, will be defined as the first hour at which the patient reports a score of 2 (normal sensation).
72 hours
Area under the pain intensity-time curve
Tidsramme: up to 72 hours
Area under the pain intensity-time curve (0-72 hours) at rest / with movement
up to 72 hours
Total postoperative opioid consumption
Tidsramme: 24, 48, 72 hours
Total postoperative opioid consumption (IV morphine mg equivalents) at 24, 48, and 72 hours
24, 48, 72 hours

Samarbejdspartnere og efterforskere

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Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • in process
  • Grant No. 20240814 (Andet bevillings-/finansieringsnummer: the Shanghai Jiao Tong University School of Medicine Double Hundred Talent Program)
  • Grant No. 82525022 (Andet bevillings-/finansieringsnummer: National Natural Science Foundation of China (NSFC) Project)

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