Pain, PostoperativePhase 3NCT07665762
Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain
A Phase 3 study testing 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine and 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone in people with Pain, Postoperative and Liposomal Bupivacaine, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The supraclavicular brachial plexus block (BPB) is a frequently used anaesthetic method for upper limb surgeries, including distal radial fracture surgery. Adding liposomal bupivacaine to BPB has shown promise in enhancing postoperative pain control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Postoperative, Liposomal Bupivacaine, Dexamethasone
- What is being tested?
- 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine and 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Aug 2026to 1 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Informed consent obtained
- Patients identified to be at an elevated risk of suffering from poor postoperative pain control. Patients with one or more of the following risk factors:
- Severe preoperative pain: defined as worse numerical rating scale (NRS) pain score equal or higher than 6/10 with arm movements at day before surgery.
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- Preoperative use of opioid: use of strong opioids such as morphine, oxycodone
- Depressive symptoms: Patient health questionnaire (PHQ-9) score of 10 or above
- Anxiety symptoms: General Anxiety Disorder (GAD-7) score of 10 or above
- 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
Who cannot join
- Revision surgery
- Previous fractures or surgery in the affected distal radius
- Surgery involving more than the affected arm
- Cases with baseline (pre-injury) QuickDASH score worse (higher) than 10 out of 100
- Respiratory compromise (requires long term oxygen)
- History of seizures
Show all 18Show fewer
- Pre-existing neurological disorder/deficit
- Alcohol or substance abuse
- 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 < 30ml/min/1.73m2
- Impaired liver function (defined as plasma bilirubin over 34μmol/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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Stanley S.C. Wong, (852) 2255 3303, wongstan@hku.hk
About this study
Official title: Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain: a Randomized Controlled Trial
The supraclavicular brachial plexus block (BPB) is a frequently used anaesthetic method for upper limb surgeries, including distal radial fracture surgery. Adding liposomal bupivacaine to BPB has shown promise in enhancing postoperative pain control. A previous randomized controlled trial demonstrated that it reduced pain scores and OBAS compared to plain bupivacaine alone, especially on postoperative day (POD) 1. Adding adjuncts to non-liposomal local anaesthetics can also enhance and prolong postoperative pain relief. The effectiveness of liposomal bupivacaine compared to adjuncts like dexamethasone and dexmedetomidine remains unclear. Since liposomal bupivacaine is more expensive, it is crucial to compare its analgesic efficacy with these alternatives. A randomized controlled trial comparing liposomal bupivacaine versus dexamethasone in the interscalene BPB for shoulder surgery found that liposomal bupivacaine resulted in statistically significantly lower pain scores and less pain interference in the Brief Pain Inventory, although the reduction was not considered clinically relevant. Its high cost may therefore limit its routine use unless specific clinical contexts where its efficacy is maximized are identified. Notably, patients with risk factors like psychological factors, preoperative pain, and prior analgesic use may benefit most from its application.
A randomized controlled trial to compare the analgesic efficacy of liposomal bupivacaine plus plain bupivacaine versus dexamethasone plus plain bupivacaine in supraclavicular BPB for patients at higher risk of poor acute pain control post distal radial fracture surgery will be conducted. Patients with severe preoperative pain, opioid use, depressive symptoms, anxiety symptoms, and/or higher energy and high-grade fracture cases will be selected. The primary outcome measured is the intensity of acute postoperative pain with movement in the first 48 hours after surgery. Important secondary outcomes include pain intensity at rest, opioid consumption, OBAS scores, chronic pain, and upper limb functionality.
- Conditions
- Pain, Postoperative, Liposomal Bupivacaine, Dexamethasone, Supraclavicular Brachial Plexus Block, High Risk Factors, Distal Radial Fracture
- Being tested
- 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine, 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone
- Keywords
- supraclavicular brachial plexus block, liposomal bupivacaine, dexamethasone, distal radial fracture, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaineDrug
10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine (133mg)
19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasoneDrug
19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB) | Active comparator | Supraclavicular brachial plexus block with 10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine Receives: Drug: 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine |
| SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB) | Experimental | Supraclavicular brachial plexus block using 19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone Receives: Drug: 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted area under curve (AUC) pain score with movement
The weighted area under curve (AUC) numerical rating scale (NRS) pain score with movement (active wrist flexion and extension) from 0-48 hours after distal radial fracture surgery.
Measured: The first 48 hours after surgery
Secondary outcomes (12)
NRS pain scores
NRS pain scores both at rest and with movement will be assessed from after surgery to POD 7. (NRS scale 0-10, where 0 is no pain, and 10 is the worst possible pain)
Measured: Postoperative day 0-7
Overall Benefit of Analgesic Score (OBAS)
Overall Benefit of Analgesic Score (OBAS) will be assessed once a day until POD 7 (range, 0 [best] to 28 [worst]).
Measured: Postoperative day 0-7
Acute postoperative opioid consumption
The daily consumption of oxycodone in the ward and after discharge will be recorded. The dose of rescue intravenous morphine consumption in the PACU will also be recorded.
Measured: Postoperative day0-7
Sleep disturbance
Sleep disturbance due to pain will be evaluated once a day till POD 7 (0-10, where 0 represents no disturbance and 10 represents the most disturbance possible).
Measured: Postoperative day0-7
Quality of recovery (QoR)
This will be accessed using the Quality of recovery (QoR) questionnaire. (range from 0 to 18, where 0 represent the worst quality of recovery and 18 represent the best quality of recovery)
Measured: Postoperative day0-7
Adverse effects related to supraclavicular BPB
The potential side effects related to the supraclavicular BPB will be recorded.
Measured: postoperative day0-2
Opioid related side effects
Opioid related side effects will be recorded.
Measured: postoperative day0-7
Analgesic block duration.
Time to return of pain, time to sensory resolution, time to motor resolution will be recorded on POD 1.
Measured: On postoperative day1
Sensory and motor assessment of the affected upper limb
Sensation to pin prick will be tested over the following areas: C5 (lateral shoulder), C6 (thumb), C7 (3rd finger), and C8 (4th finger) dermatomes. Motor assessment will be done by recording grip strength and bicep contraction. Sensation will be rated as 0-10 , where 0 represent no sensation and 10 represent normal sensation. Motor function will be rated as 0 (paralysis), 1 (paresis), 2 (normal power).
Measured: Postoperative day0-1
Health related quality of life
Health related quality of life will be assessed using the SF-12v2. Baseline scores will be obtained before surgery. The SF-12v2 will produce two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both summary scores range from 0 to 100, where higher scores always indicate better physical and mental health.
Measured: Baseline and at 3, 6 and 12 weeks after surgery
Upper limb functional scores.
The validated Chinese versions of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) will be used to assess upper limb functional scores. Baseline scores will be obtained before surgery. (Range from 0 to 100, a lower score indicates a better outcome)
Measured: Baseline and at 3, 6 and 12 weeks after surgery
Hand grip power of normal and injured side
Hand grip power of normal and injured side will be assessed (both hands).
Measured: At 3, 6 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start4 Aug 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665762
- Sponsor's protocol ID
- UW 25-516
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07665762
- Acronym / sponsor ID
- UW 25-516
- Conditions
- Pain, Postoperative, Liposomal Bupivacaine, Dexamethasone, Supraclavicular Brachial Plexus Block, High Risk Factors, Distal Radial Fracture
- Keywords
- supraclavicular brachial plexus block, liposomal bupivacaine, dexamethasone, distal radial fracture, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The supraclavicular brachial plexus block (BPB) is a frequently used anaesthetic method for upper limb surgeries, including distal radial fracture surgery. Adding liposomal bupivacaine to BPB has shown promise in enhancing postoperative pain control. A previous randomized controlled trial demonstrated that it reduced pain scores and OBAS compared to plain bupivacaine alone, especially on postoperative day (POD) 1. Adding adjuncts to non-liposomal local anaesthetics can also enhance and prolong postoperative pain relief. The effectiveness of liposomal bupivacaine compared to adjuncts like dexamethasone and dexmedetomidine remains unclear. Since liposomal bupivacaine is more expensive, it is crucial to compare its analgesic efficacy with these alternatives. A randomized controlled trial comparing liposomal bupivacaine versus dexamethasone in the interscalene BPB for shoulder surgery found that liposomal bupivacaine resulted in statistically significantly lower pain scores and less pain interference in the Brief Pain Inventory, although the reduction was not considered clinically relevant. Its high cost may therefore limit its routine use unless specific clinical contexts where its efficacy is maximized are identified. Notably, patients with risk factors like psychological factors, preoperative pain, and prior analgesic use may benefit most from its application.
A randomized controlled trial to compare the analgesic efficacy of liposomal bupivacaine plus plain bupivacaine versus dexamethasone plus plain bupivacaine in supraclavicular BPB for patients at higher risk of poor acute pain control post distal radial fracture surgery will be conducted. Patients with severe preoperative pain, opioid use, depressive symptoms, anxiety symptoms, and/or higher energy and high-grade fracture cases will be selected. The primary outcome measured is the intensity of acute postoperative pain with movement in the first 48 hours after surgery. Important secondary outcomes include pain intensity at rest, opioid consumption, OBAS scores, chronic pain, and upper limb functionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB) | Active comparator | Drug: 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaineSupraclavicular brachial plexus block with 10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine |
| SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB) | Experimental | Drug: 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasoneSupraclavicular brachial plexus block using 19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- Informed consent obtained
- Patients identified to be at an elevated risk of suffering from poor postoperative pain control. Patients with one or more of the following risk factors:
Key exclusion criteria (18 listed)
- Revision surgery
- Previous fractures or surgery in the affected distal radius
- Surgery involving more than the affected arm
- Cases with baseline (pre-injury) QuickDASH score worse (higher) than 10 out of 100
- Respiratory compromise (requires long term oxygen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine (133mg) | Drug | SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB) |
| 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone | Drug | SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB) |
Primary outcome
Weighted area under curve (AUC) pain score with movement
Time frame: The first 48 hours after surgery
The weighted area under curve (AUC) numerical rating scale (NRS) pain score with movement (active wrist flexion and extension) from 0-48 hours after distal radial fracture surgery.
12 secondary outcomes
NRS pain scores
Time frame: Postoperative day 0-7
Overall Benefit of Analgesic Score (OBAS)
Time frame: Postoperative day 0-7
Acute postoperative opioid consumption
Time frame: Postoperative day0-7
Sleep disturbance
Time frame: Postoperative day0-7
Quality of recovery (QoR)
Time frame: Postoperative day0-7
Adverse effects related to supraclavicular BPB
Time frame: postoperative day0-2
Opioid related side effects
Time frame: postoperative day0-7
Analgesic block duration.
Time frame: On postoperative day1
Sensory and motor assessment of the affected upper limb
Time frame: Postoperative day0-1
Health related quality of life
Time frame: Baseline and at 3, 6 and 12 weeks after surgery
Upper limb functional scores.
Time frame: Baseline and at 3, 6 and 12 weeks after surgery
Hand grip power of normal and injured side
Time frame: At 3, 6 and 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine and 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone in people with Pain, Postoperative and Liposomal Bupivacaine, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanley S.C. Wong ((852) 2255 3303, wongstan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weighted area under curve (AUC) pain score with movement (time frame: The first 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.