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Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia

23. maj 2026 opdateret af: Hongwei Shi, Nanjing First Hospital, Nanjing Medical University

Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study

To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

184

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, Kina
        • Nanjing Gaochun People's Hospital
      • Suzhou, Jiangsu, Kina
        • the First Affiliated Hospital of Soochow University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients scheduled for elective unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
  • Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
  • Patient provides informed consent;
  • Age 18-80 years, any gender;
  • ASA physical status I-III;
  • 18 kg/m² ≤ BMI ≤ 30 kg/m².

Exclusion Criteria:

  • Coagulopathy;
  • Allergy to local anesthetics;
  • Infection at the puncture site;
  • History of chronic pain or opioid use;
  • Severe respiratory disease;
  • Pregnancy;
  • Diabetes and peripheral neuropathy;
  • Inability to understand assessment scales.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Liposomal Bupivacaine
When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
Medicin: Liposomal bupivacaine
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 1.33% Liposomal bupivacaine 10ml was injected.
Aktiv komparator: Bupivacaine Hydrochloride
When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.
Medicin: Bupivacaine Hydrochloride
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 0.375% Bupivacaine Hydrochloride 10ml was injected.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
Tidsramme: Before block 、before leaving the PACU after surgery and 24 hours after surgery
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of >75% is defined as complete diaphragmatic paralysis.
Before block 、before leaving the PACU after surgery and 24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numeric Rating Scale (NRS) scores during activity and at rest
Tidsramme: Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
Pain intensity at the surgical site will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Patients will self-report their pain intensity at rest (Resting NRS) and during active movement (Dynamic NRS)
Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
The area under the pain intensity-time curve (PI-AUC)
Tidsramme: Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
The Pain Intensity-Area Under the Curve (PI-AUC) will be calculated as a summary measure of overall pain burden over time. The AUC for each patient will be computed for three consecutive postoperative periods based on the serial NRS scores (both resting and dynamic) collected during those intervals. A smaller AUC indicates better overall analgesic control during the specified period.
Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
Postoperative recovery quality (QoR-15 score)
Tidsramme: Postoperative days 1, 2, and 3
Patient-reported recovery quality will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. This validated tool evaluates physical comfort, physical independence, psychological support, emotional state, and pain. Scores range from 0 (extremely poor recovery) to 150 (excellent recovery). The upward trend of the QoR-15 score signifies a progressive and comprehensive improvement in a patient's postoperative recovery experience across physical, emotional, and functional domains.
Postoperative days 1, 2, and 3
Analgesia satisfaction (OBAS score)
Tidsramme: Postoperative days 1, 2, and 3
Patient satisfaction with analgesia and its associated side effects will be evaluated using the Overall Benefit of Analgesia Score (OBAS). The OBAS is a composite score (range 0-28, lower is better) incorporating assessments of pain intensity, nausea/vomiting, dizziness, sedation, itching, and patient satisfaction. The downward trend of the OBAS score indicates a progressively more favorable balance between analgesic efficacy and the burden of treatment-related side effects, representing an increasing net benefit of the analgesia regimen.
Postoperative days 1, 2, and 3
Morphine equivalent consumption
Tidsramme: Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The total consumption of all opioid analgesics administered to the patient (including patient-controlled analgesia and rescue doses). All opioid doses will be converted to intravenous morphine milligram equivalents (MME) using standard conversion ratios for summation and comparison. A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
Tidsramme: 0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
This refers specifically to the summed dose of supplemental (rescue) opioid analgesics administered upon patient request for breakthrough pain. The cumulative dose for each period will be calculated and expressed in intravenous morphine milligram equivalents (MME). A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
Telephone follow-up for pain NRS score
Tidsramme: Postoperative 3 months
Patients will be contacted by telephone at 3 months after surgery. They will be asked to self-report their current average pain intensity over the past 24 hours at the surgical site using the 11-point Numeric Rating Scale (NRS, 0-10), where 0 represents "no pain" and 10 represents "the worst pain imaginable." This assesses the potential long-term impact of the analgesic intervention on persistent postoperative pain.
Postoperative 3 months
Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
Tidsramme: Postoperative 72 hours

Vascular injury: Evidence of hematoma or vascular puncture during needle placement.

Hoarseness: Patient-reported or clinician-identified voice change suggestive of recurrent laryngeal nerve involvement.

Horner's syndrome: Presence of ptosis, miosis, and/or anhidrosis on the blocked side.

Diaphragmatic paralysis: defined by a reduction in diaphragmatic excursion amplitude >25% from baseline on ultrasound assessment performed post-block.

SpO2 <90% on room air after PACU discharge: Oxygen saturation falling below 90% while breathing room air, occurring after the patient has been discharged from the PACU, and not related to other obvious causes.

Dyspnea: Subjective sensation of shortness of breath or labored breathing. Finger numbness: Persistent numbness or loss of sensation in the fingers of the blocked upper limb.

Motor difficulty: Persistent weakness or inability to perform specific voluntary movements in the blocked upper limb.
Postoperative 72 hours

Samarbejdspartnere og efterforskere

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Sponsor

Nanjing First Hospital, Nanjing Medical University

Publikationer og nyttige links

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Generelle publikationer

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)

6. maj 2026

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20260402-03

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