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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in 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)

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 groups in NCT04928664
Study groupRoleWhat they receive
Liposoaml Bupivacaine (LB) GroupActive comparatorIntervention group
Receives: Drug: Liposomal bupivacaine
Standard Bupivacaine (SB) GroupExperimentalControl group
Receives: Drug: Standard bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted16 Jun 2021
  2. Study start9 Sep 2020
  3. Primary completion13 Dec 2025
  4. Study completion5 Mar 2026

Resources

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)
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

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.

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