Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
27. august 2026 oppdatert av: Qing-he Zhou, Affiliated Hospital of Jiaxing University
This study aims to evaluate whether 15ml/75mg low-dose bupivacaine liposome is non-inferior to 15ml/133mg standard-dose bupivacaine liposome for postoperative analgesia in interscalene brachial plexus block during arthroscopic shoulder surgery, through a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial.
It will also assess whether 15ml/75mg low-dose bupivacaine liposome is superior to 15ml/133mg standard-dose bupivacaine liposome in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions during interscalene brachial plexus block.
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Detaljert beskrivelse
This study is designed as a single-center, prospective, double-blind, non-inferiority randomized controlled clinical trial, to evaluate and compare whether the postoperative analgesic efficacy of 15 mL/75 mg low-dose liposomal bupivacaine for interscalene brachial plexus block in patients undergoing shoulder arthroscopy is non-inferior to that of 15 mL/133 mg standard-dose liposomal bupivacaine, and to further assess whether the low-dose regimen demonstrates advantages over the standard-dose counterpart in terms of diaphragmatic excursion, pulmonary function, duration of block effect, and nerve block-related adverse reactions.
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Zhejiang
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Jiaxing, Zhejiang, Kina, 314000
- Jiaxing University Affiliated Hospital
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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:
- Patients aged 18 years or older.
- ASA classification I-III.
- Arthroscopic shoulder rotator cuff repair, capsular plication, acromioplasty, synovectomy, etc.
Exclusion Criteria:
- Have a history of lung disease.
- Coagulation dysfunction or coagulopathy.
- History of allergy to local anesthetics.
- infection or lesions at the block site; or history of cervical spine disease.
- pregnancy.
- Refusal to participate in the study or inability to communicate.
- Long-term use of opioids.
- Body mass index >35 kg/m2
- Previous history of nerve injury, paralysis, or paresis;
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: OBV bupivacaine liposome group
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg.
This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
|
Following our preliminary study protocol, 13 mL of liposomal bupivacaine (derived from the 20 mL/266 mg commercial formulation) is aspirated and further diluted with 0.9% sodium chloride injection to a final total volume of 53 mL while maintaining the fixed total dose of 266 mg.
This diluted preparation is then combined with 2 mL of 0.5% conventional bupivacaine, and the resultant 55 mL mixture is administered to perform interscalene brachial plexus block prior to surgical incision.
|
|
Eksperimentell: Standard dose bupivacaine liposome group
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene brachial plexus block prior to surgical incision.
|
Following the recommendations in published literature and the approved product labeling, 10 mL of liposomal bupivacaine (20 mL/266 mg formulation) is aspirated, combined with 2 mL of 0.5% conventional bupivacaine, diluted to a final total volume of 15 mL with 0.9% sodium chloride injection, and administered to perform ultrasound-guided interscalene
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in numeric rating scale scores for resting pain at 24 hours after surgery
Tidsramme: postoperative 24 hours
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Difference in numeric rating scale scores(0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) for resting pain at 24 hours after surgery.
Postoperatively, the NRS scale was used to evaluate pain scores.
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postoperative 24 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total consumption of morphine milligram equivalents within 72 hours postoperatively
Tidsramme: within 72 hours postoperatively
|
Record opioid analgesics within 72 hours postoperatively, convert to morphine equivalent dose, and calculate the total amount.
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within 72 hours postoperatively
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Differences in numeric rating scale pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Tidsramme: postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
|
Differences in numeric rating scale (0 = no pain, 10 = worst pain; higher numbers indicate greater pain intensity) pain scores at rest and during activity within 0.5 hours, 6 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Postoperatively, the NRS scoring scale was used to assess pain scores.
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postoperative 0.5 hours, 6 hours, 24 hours, 48 hours, 72 hours
|
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Complete unilateral HDP during quiet breathing at 0.5 hours 6 hours, and 24 hours after completion of block
Tidsramme: postoperative 0.5 hours, 6 hours and 24 hours
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A diaphragm excursion of >75% on the blocked side measured under ultrasound is defined as complete unilateral hemidiaphragmatic paralysis (HDP).
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postoperative 0.5 hours, 6 hours and 24 hours
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Pulmonary function
Tidsramme: postoperative 0.5 hours, 6 hours and 24 hours
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Use a portable respiratory function tester for bedside testing; have the patient blow three times and take the average.
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postoperative 0.5 hours, 6 hours and 24 hours
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All adverse events related to surgery and anesthesia occurring within 72 hours postoperatively
Tidsramme: within 72 hours postoperatively
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Adverse events associated with nerve blocks within 72 hours postoperatively, including pneumothorax, intravascular injection, local anesthetic toxicity, and Horner syndrome, were recorded.
|
within 72 hours postoperatively
|
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The number of rescue analgesic interventions required within 72 hours postoperatively
Tidsramme: within 72 hours postoperatively
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The number of analgesic administrations within the first 72 hours postoperatively was recorded.
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within 72 hours postoperatively
|
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sensorimotor score
Tidsramme: postoperative 0.5 hours, 6 hours and 24 hours
|
After completion of the block, the simplified sensorimotor assessment scale (3-point method) is used for evaluation, and a total sensorimotor score ≥12 points with a total sensory score ≥3 points is defined as successful brachial plexus block.
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postoperative 0.5 hours, 6 hours and 24 hours
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2028
Datoer for studieregistrering
Først innsendt
23. august 2026
Først innsendt som oppfylte QC-kriteriene
27. august 2026
Først lagt ut (Faktiske)
28. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-LP-402
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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