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Analgesic Effect of Liposomal Bupivacaine

NCT05118399 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-16

No results posted yet for this study

Summary

Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery, and is usually associated with moderate postoperative pain. Poor postoperative pain control can impair rehabilitation, delay recovery and negatively impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. Liposomal bupivacaine can provide longer analgesia for up to 72 hours, and may therefore achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics. A number of clinical trials have studied the effect liposomal bupivacaine given as local infiltration. However, there is little evidence on liposomal bupivacaine for regional nerve blocks, and the use of liposomal bupivacaine for supraclavicular brachial plexus block - which is used for regional anaesthesia for distal radial fracture surgery - have not been studied before. This project is a randomized controlled trial to determine whether adding liposomal bupivacaine to long-acting local anaesthetics for supraclavicular BPB will improve and prolong postoperative analgesia in patients undergoing distal radial fracture surgery. Longer term secondary outcomes would be accessed including upper limb functional scores, chronic pain, and health related quality of life.

Conditions

  • Acute Pain

Interventions

DRUG

Bupivacaine Injection [Marcaine]

Bupivacaine injection \[Marcaine\] is the standard treatment used in our hospital.

DRUG

Bupivacaine Liposome 13.3 MG/ML [Exparel]

Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-12-08
Completion
2023-03-08

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118399 on ClinicalTrials.gov