Shoulder FracturesPhase 4NCT04928664
Continuous vs Liposomal Bupivacaine Interscalene Block for Proximal Humeral Fracture (CLIP)
A Phase 4 study testing Liposomal bupivacaine and Standard bupivacaine in people with Shoulder Fractures, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Restricted range of shoulder motion following ORIF is a potential complication that severely affects the patients' functional outcome and should be actively avoided by means of adequate pain control in addition to early mobilization and physiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- Liposomal bupivacaine and Standard bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesHong Kong
- Study dates
- 9 Sep 2020to 5 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age between 18 and 80
- Proximal humeral fracture
Who cannot join
- Surgical exclusion criteria:
- Revision surgery
- Pathological fracture
- 4-part or shaft fracture
- Multiple fractures
- Unable to attend rehabilitation
Show all 22Show fewer
- Preexisting shoulder problems
- Abbreviated Mental Test Score (AMT score) < 8
- Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids
- Respiratory Disease with limited respiratory reserve
- Cardiac Disease: Any degree of Heart Block, Heart Failure
- Neurological: Any Seizure Disorder
- Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder
- Alcohol or substance abuse
- Chronic Pain, other than chronic knee pain
- Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, diamorphine, oxycodone, or meperidine) before operation
- Impaired Renal Function (defined as preoperative eGFR < 30ml /min /1.73 m2)
- Impaired Hepatic Function
- Pregnancy
- Inability to use PCA
- Patient refusal to ISB
- Patient refusal to study
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
The University of Hong Kong
Hong Kong
About this study
Official title: Continuous Standard Bupivacaine Versus Single Liposomal Bupivacaine Injection for Interscalene Brachial Plexus Block for Pain Management After Proximal Humerus Fracture Fixation
Restricted range of shoulder motion following ORIF is a potential complication that severely affects the patients' functional outcome and should be actively avoided by means of adequate pain control in addition to early mobilization and physiotherapy.
Peripheral nerve blocks, which can be given as a single injection or continuous infusion via an indwelling catheter, are analgesic options to be considered. Interscalene Block (ISB) is the regional analgesia of choice for the shoulder and proximal humerus region. While continuous infusion (aka continuous nerve block) offers the advantage of a longer duration of analgesia compared to a single injection of standard local anaesthetic, it is associated with an inherent risk of catheter displacement, dislodgement, obstruction, and infection.
Compared to Standard Bupivacaine (SB), Liposomal Bupivacaine (LB) is a formulation designed to prolong the duration of action to up to 72 hours by slow release of bupivacaine from the multi-vesicular liposomes. Several studies have demonstrated satisfactory analgesic effects of liposomal bupivacaine given as local surgical site infiltration over placebo. However, the effects of single injection of liposomal bupivacaine given via local surgical site infiltration compared to continuous nerve block have been inconsistent. Administrating liposomal bupivacaine directly to peripheral nerve blocks is a potentially effective approach that has not been extensively studied. ISB with single shot liposomal bupivacaine has been shown to provide superior postoperative analgesia compared to ISB with injection of standard bupivacaine or placebo. ISB with liposomal bupivacaine could perhaps prolong and improve postoperative analgesia without the potential problems with continuous nerve blocks. The analgesic effect of ISB with single shot liposomal bupivacaine versus continuous ISB with standard bupivacaine has not been previously investigated. The aim of this study is to compare the analgesic effect of these two analgesic modalities for plate fixation of proximal humerus fractures.
Read the detailed description
CONDUCT OF ISB:
Side effects and potential complications will be explained and informed consent will be obtained from all subjects.
Time-out will be performed before the start of ISB in accordance with the WHO checklist, confirming the side of surgery with the subject.
Standard monitoring will be placed and an intravenous catheter will be established.
All ISB will be performed by anaesthetists experienced in ultrasound-guided ISB.
An aseptic technique will be applied. ISB will be performed under ultrasound guidance in an in-plane manner. Catheter-over-needle set with a 50mm short-bevel insulated needle will be used.
Placement of needle will be confirmed with sonoanatomy, absence of persistent paraesthesia, negative aspiration of air and blood, real-time visualisation of the spread of drug and low resistance upon injection. The catheter will be left in-situ and sutured to the skin after injection of the drug and withdrawal of the needle.
Neither the supraclavicular nerve nor the suprascapular nerve will be blocked.
The use of a peripheral nerve stimulator and administration of sedation will be at the discretion of the attending anaesthetist.
A successful ISB is defined as loss of cold sensation to ice in the C5 dermatome, which will be tested by the attending anaesthetist in addition to assessing the presence of aforementioned complications before induction of general anaesthesia.
ANAESTHESIA \& ANALGESIA:
(I) PRE-OPERATIVE:
Routine preoperative assessment will be taken at the pre-admission clinic or at the general ward, followed by these orders:
ECG and chest x-ray Standard fasting times (6 hours for solid food and 2 hours for clear liquid) No analgesics or sedatives as premeditation
(II) INTRA-OPERATIVE: ISB will be performed as described above before induction of General Anaesthesia (GA).
For Induction of GA:
IV Fentanyl 1-2mcg/kg IV Propofol 2-4 mg/kg IV Rocuronium 0.6-1mg/kg
For Maintenance of GA:
Target controlled infusion of propofol at an effect site concentration of 0-1.5 mcg/ml Air/O2/desflurane, target MAC: 0.6 -1.0 IV Morphine 3mg before skin incision IV Remifentanil 0.1-0.2 mcg/kg/min, target SBP not more than 20% increase from baseline Choice of muscle relaxant and IV fluid at the discretion of the attending anaesthetist Vasopressors, anti-hypertensive medications, anti-arrhythmia medications may be given as necessary No Paracetamol / NSAID / Ketamine / Dexmedetomidine / IV Lidocaine infusion / Magnesium No LA infiltration
For Emergence from GA:
IV Ondansetron 4mg 30 minutes before the end of surgery Reversal will be achieved with 2.5 mg of neostigmine and 1.2 mg of atropine and patients will be extubated when ventilation and consciousness is adequate
(III) POST-OPERATIVE (RECOVERY IN PACU): All subjects will be transferred to PACU for further monitoring for at least 30 minutes.
The indwelling catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse.
Pain at rest will be evaluated every 5 mins using NRS. If the score is greater than 4/10, 2mg morphine will be given intravenously every 5 mins provided the subject has a respiratory rate of > 12/min and a sedation score of <1 until a NRS of < 4/10 is achieved.
The presence of complications will be assessed by the attending anaesthetist before discharge from PACU.
(IV) POST-OPERATIVE (IN WARD): BP, heart rate, SpO2, and sedation score will be monitored at 1-hour intervals while on PCA morphine; BP and heart rate will be monitored at 4-hour intervals once PCA morphine is terminated.
Diet will be resumed on Post-Operative Day 0. All subjects will undergo standard institutional rehabilitation program, which consists of supervised passive forward flexion and external rotation exercise for 3 weeks, followed by assisted active movements till 6 weeks.
Standardized analgesic regime will be prescribed:
IV PCA morphine for 2 days PO paracetamol 500mg QID for 2 weeks PO celecoxib 200mg daily for 3 days IMI morphine 0.1mg/kg Q4H prn as rescue analgesic for 3 days IV ondansetron 0.1mg/kg Q8H prn for 3 days PO Dihydrocodeine 30mg TDS prn from POD3 to PO7
Signs and symptoms of complications will be assessed by the pain team daily until postoperative day 2 when the pump and catheter will be removed. Pain assessment and side effects related to analgesic will be assessed by the pain team daily until postoperative day 2, followed by phone follow-up until postoperative day 7
For phone follow-up, patients will be received a phone call in the afternoon at around 3 pm for both pain score and Overall Benefit of Analgesic Scale (OBAS)
- Conditions
- Shoulder Fractures
- Being tested
- Liposomal bupivacaine, Standard bupivacaine
- Keywords
- liposomal bupivacaine, interscalene block
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Single shot injection of 10ml 1.33% LB; Due to the milky colour of LB, syringe containing the LB will be covered; Followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml NS; The default fixed rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by an aluminium foil; Catheter and pump will be removed on post-operative day 2
Standard bupivacaineDrug
Single shot injection of 10 ml 0.25% SB in ISB; In order to have blinding to the drug injected, syringe containing SB will be covered; followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml 0.2% SB; The default fixed-rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by an aluminium foil; Catheter and pump will be removed on post-operative day 2
| Study group | Role | What they receive |
|---|---|---|
| Liposoaml Bupivacaine (LB) Group | Active comparator | Intervention group Receives: Drug: Liposomal bupivacaine |
| Standard Bupivacaine (SB) Group | Experimental | Control group Receives: Drug: Standard bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted area under curve (AUC) pain score at rest
Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain
Measured: 0-48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start9 Sep 2020
- Primary completion13 Dec 2025
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A separate anaesthetist will then prepare 10 ml of LB or SB, and a covered elastomeric pump that is either filled with 300ml NS or with 300ml 0.2% SB according to the group assigned for the attending anaesthetist.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Chi-Wing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928664
- Sponsor's protocol ID
- UW 20-247
- Status last verified
- May 2026
- First submitted
- 1 Jun 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Standard Bupivacaine Versus Single Liposomal Bupivacaine Injection for Interscalene Brachial Plexus Block for Pain Management After Proximal Humerus Fracture Fixation
- ClinicalTrials.gov ID
- NCT04928664
- Acronym / sponsor ID
- UW 20-247
- Conditions
- Shoulder Fractures
- Keywords
- liposomal bupivacaine, interscalene block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 13 Dec 2025 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 16 Jun 2021 (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.
Restricted range of shoulder motion following ORIF is a potential complication that severely affects the patients' functional outcome and should be actively avoided by means of adequate pain control in addition to early mobilization and physiotherapy.
Peripheral nerve blocks, which can be given as a single injection or continuous infusion via an indwelling catheter, are analgesic options to be considered. Interscalene Block (ISB) is the regional analgesia of choice for the shoulder and proximal humerus region. While continuous infusion (aka continuous nerve block) offers the advantage of a longer duration of analgesia compared to a single injection of standard local anaesthetic, it is associated with an inherent risk of catheter displacement, dislodgement, obstruction, and infection.
Compared to Standard Bupivacaine (SB), Liposomal Bupivacaine (LB) is a formulation designed to prolong the duration of action to up to 72 hours by slow release of bupivacaine from the multi-vesicular liposomes. Several studies have demonstrated satisfactory analgesic effects of liposomal bupivacaine given as local surgical site infiltration over placebo. However, the effects of single injection of liposomal bupivacaine given via local surgical site infiltration compared to continuous nerve block have been inconsistent. Administrating liposomal bupivacaine directly to peripheral nerve blocks is a potentially effective approach that has not been extensively studied. ISB with single shot liposomal bupivacaine has been shown to provide superior postoperative analgesia compared to ISB with injection of standard bupivacaine or placebo. ISB with liposomal bupivacaine could perhaps prolong and improve postoperative analgesia without the potential problems with continuous nerve blocks. The analgesic effect of ISB with single shot liposomal bupivacaine versus continuous ISB with standard bupivacaine has not been previously investigated. The aim of this study is to compare the analgesic effect of these two analgesic modalities for plate fixation of proximal humerus fractures.
Detailed description
CONDUCT OF ISB:
Side effects and potential complications will be explained and informed consent will be obtained from all subjects.
Time-out will be performed before the start of ISB in accordance with the WHO checklist, confirming the side of surgery with the subject.
Standard monitoring will be placed and an intravenous catheter will be established.
All ISB will be performed by anaesthetists experienced in ultrasound-guided ISB.
An aseptic technique will be applied. ISB will be performed under ultrasound guidance in an in-plane manner. Catheter-over-needle set with a 50mm short-bevel insulated needle will be used.
Placement of needle will be confirmed with sonoanatomy, absence of persistent paraesthesia, negative aspiration of air and blood, real-time visualisation of the spread of drug and low resistance upon injection. The catheter will be left in-situ and sutured to the skin after injection of the drug and withdrawal of the needle.
Neither the supraclavicular nerve nor the suprascapular nerve will be blocked.
The use of a peripheral nerve stimulator and administration of sedation will be at the discretion of the attending anaesthetist.
A successful ISB is defined as loss of cold sensation to ice in the C5 dermatome, which will be tested by the attending anaesthetist in addition to assessing the presence of aforementioned complications before induction of general anaesthesia.
ANAESTHESIA \& ANALGESIA:
(I) PRE-OPERATIVE:
Routine preoperative assessment will be taken at the pre-admission clinic or at the general ward, followed by these orders:
ECG and chest x-ray Standard fasting times (6 hours for solid food and 2 hours for clear liquid) No analgesics or sedatives as premeditation
(II) INTRA-OPERATIVE: ISB will be performed as described above before induction of General Anaesthesia (GA).
For Induction of GA:
IV Fentanyl 1-2mcg/kg IV Propofol 2-4 mg/kg IV Rocuronium 0.6-1mg/kg
For Maintenance of GA:
Target controlled infusion of propofol at an effect site concentration of 0-1.5 mcg/ml Air/O2/desflurane, target MAC: 0.6 -1.0 IV Morphine 3mg before skin incision IV Remifentanil 0.1-0.2 mcg/kg/min, target SBP not more than 20% increase from baseline Choice of muscle relaxant and IV fluid at the discretion of the attending anaesthetist Vasopressors, anti-hypertensive medications, anti-arrhythmia medications may be given as necessary No Paracetamol / NSAID / Ketamine / Dexmedetomidine / IV Lidocaine infusion / Magnesium No LA infiltration
For Emergence from GA:
IV Ondansetron 4mg 30 minutes before the end of surgery Reversal will be achieved with 2.5 mg of neostigmine and 1.2 mg of atropine and patients will be extubated when ventilation and consciousness is adequate
(III) POST-OPERATIVE (RECOVERY IN PACU): All subjects will be transferred to PACU for further monitoring for at least 30 minutes.
The indwelling catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse.
Pain at rest will be evaluated every 5 mins using NRS. If the score is greater than 4/10, 2mg morphine will be given intravenously every 5 mins provided the subject has a respiratory rate of > 12/min and a sedation score of <1 until a NRS of < 4/10 is achieved.
The presence of complications will be assessed by the attending anaesthetist before discharge from PACU.
(IV) POST-OPERATIVE (IN WARD): BP, heart rate, SpO2, and sedation score will be monitored at 1-hour intervals while on PCA morphine; BP and heart rate will be monitored at 4-hour intervals once PCA morphine is terminated.
Diet will be resumed on Post-Operative Day 0. All subjects will undergo standard institutional rehabilitation program, which consists of supervised passive forward flexion and external rotation exercise for 3 weeks, followed by assisted active movements till 6 weeks.
Standardized analgesic regime will be prescribed:
IV PCA morphine for 2 days PO paracetamol 500mg QID for 2 weeks PO celecoxib 200mg daily for 3 days IMI morphine 0.1mg/kg Q4H prn as rescue analgesic for 3 days IV ondansetron 0.1mg/kg Q8H prn for 3 days PO Dihydrocodeine 30mg TDS prn from POD3 to PO7
Signs and symptoms of complications will be assessed by the pain team daily until postoperative day 2 when the pump and catheter will be removed. Pain assessment and side effects related to analgesic will be assessed by the pain team daily until postoperative day 2, followed by phone follow-up until postoperative day 7
For phone follow-up, patients will be received a phone call in the afternoon at around 3 pm for both pain score and Overall Benefit of Analgesic Scale (OBAS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A separate anaesthetist will then prepare 10 ml of LB or SB, and a covered elastomeric pump that is either filled with 300ml NS or with 300ml 0.2% SB according to the group assigned for the attending anaesthetist.
| Arm | Type | Receives |
|---|---|---|
| Liposoaml Bupivacaine (LB) Group | Active comparator | Drug: Liposomal bupivacaineIntervention group |
| Standard Bupivacaine (SB) Group | Experimental | Drug: Standard bupivacaineControl group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Age between 18 and 80
- Proximal humeral fracture
Key exclusion criteria (22 listed)
- Surgical exclusion criteria:
- Revision surgery
- Pathological fracture
- 4-part or shaft fracture
- Multiple fractures
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 |
|---|---|---|
| Liposomal bupivacaineSingle shot injection of 10ml 1.33% LB; Due to the milky colour of LB, syringe containing the LB will be covered; Followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml NS; The default fixed rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by an aluminium foil; Catheter and pump will be removed on post-operative day 2 | Drug | Liposoaml Bupivacaine (LB) Group |
| Standard bupivacaineSingle shot injection of 10 ml 0.25% SB in ISB; In order to have blinding to the drug injected, syringe containing SB will be covered; followed by placement of indwelling catheter in ISB; Catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse; The pump will be filled with 300ml 0.2% SB; The default fixed-rate of infusion will be 5ml/hr; Both the pump and the clamp will be covered by an aluminium foil; Catheter and pump will be removed on post-operative day 2 | Drug | Standard Bupivacaine (SB) Group |
Primary outcome
Weighted area under curve (AUC) pain score at rest
Time frame: 0-48 hours after surgery
Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and Standard bupivacaine in people with Shoulder Fractures, run by The University of Hong Kong at 2 sites 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 3 inclusion and 22 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weighted area under curve (AUC) pain score at rest (time frame: 0-48 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 18 May 2026.