Analgesic Effect of Liposomal Bupivacaine

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

American Society of Anesthesiologist (ASA) status I-III
Age 18-90 years old
Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)
Patients with informed consent to participate in the study

Exclusion criteria

Ulnar shaft/ neck physis fracture
Revision surgery
Previous fractures or surgery in the affected distal radius
Surgery involving more than the affected arm
Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
Cases with painful conditions affecting the upper limb prior to surgery such as cervical spine, shoulder, elbow, other hand and wrist problems
Cases with baseline (pre-injury) QuickDASH score worse than 10 out of 100
Respiratory compromise (requires long term oxygen)
History of seizures
Pre-existing neurological disorder/deficit
Chronic opioid user (use for 3 months or more)
Presence of chronic pain condition (pain duration over 3 months)
Alcohol or substance abuse
Psychiatric illness
Impaired mental state
Local infection
Allergy to analgesic drugs: local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids
Impaired renal function (defined as effective glomerular filtration rate less than 30ml/min/1.73m2
Impaired liver function (defined as plasma bilirubin over 34micromol/L; international normalized ratio [INR] 》／=1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
Coagulopathy (platelet count 《100,000/ml and/or INR 》／=1.5) or the use of anticoagulants (not including aspirin) that precludes the use of supraclavicular BPB
Pregnancy
Patient refusal for regional nerve blocks
Patient refusal to join the clinical trial
Patient unable/unwilling to attend post-op rehabilitation programme
Injury on duty

Treatment and study plan

Bupivacaine Injection [Marcaine]

Drug

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

Bupivacaine Liposome 13.3 MG/ML [Exparel]

Drug

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

Primary outcomes

postoperative AUC pain score at rest

Time frame: First 48 hours after surgery

Pain severity would be rated at rest after surgery using numerical rating scale with 0 to 10 where 0=no pain and 10=the worst possible pain

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Addition of Liposomal Bupivacaine to Standard Bupivacaine Versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: a Randomized Controlled Trial

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Nov 12, 2021
Registry last updated: Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed