Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery.
Liposomal Bupivacaine Combined With Plain Bupivacaine for Peripheral Nerve Block to Reduce Rebound Pain After Orthopedic Extremity Surgery: A Multicenter Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200233
- Shanghai Sixth People's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 18-65 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 that preclude study participation.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: liposomal bupivacaine
5 ml of plain bupivacaine 0.75% will be mixed with 10 ml liposomal bupivacaine (133mg)
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Prepare a local anesthetic by combining liposomal bupivacaine (133 mg/10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.
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Placebo komparator: normal saline
5 ml of plain bupivacaine 0.75% will be combined with 10 ml of normal saline
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Prepare a local anesthetic by combining normal saline (10 mL) and bupivacaine hydrochloride (75 mg/10 mL) in a 2:1 volume ratio.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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incidence of rebound pain
Tidsramme: the first 24 hours after surgery
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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.
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the first 24 hours after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Area under the pain intensity-time curve
Tidsramme: up to 72 hours
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Area under the pain intensity-time curve (0-72 hours) at rest / with movement
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up to 72 hours
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Total postoperative opioid consumption
Tidsramme: 24, 48, 72 hours
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Total postoperative opioid consumption (IV morphine mg equivalents) at 24, 48, and 72 hours
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24, 48, 72 hours
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BLOC trial
- Grant No. 20240814 (Annet stipend/finansieringsnummer: the Shanghai Jiao Tong University School of Medicine Double Hundred Talent Program)
- Grant No. 82525022 (Annet stipend/finansieringsnummer: National Natural Science Foundation of China (NSFC) Project)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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