Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery
NCT ID: NCT05084573
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
92 participants
INTERVENTIONAL
2020-08-01
2023-03-31
Brief Summary
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Detailed Description
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Interscalene block (ISB) is one of the most effective and widely used regional analgesic options shoulder surgeries. ISB can be delivered as a single injection or by continuous infusion via an indwelling catheter. While continuous interscalene block (CISB) offers a longer duration of analgesia as compared to a single injection of the same anaesthetic, it carries an inherent risk of catheter malposition, dislodgement, and infection.
As compared to standard bupivacaine (SB), liposomal bupivacaine (LB) is a formulation designed to prolong the duration of analgesia up to 72 hours via a single injection. While this could avoid the need for an indwelling catheter, results of studies comparing LB to CISB have been inconsistent.
The purpose of this is non-inferiority trial is to compare the effectiveness of a single injection of LB versus CISB with SB on pain control following ORIF of proximal humerus fractures. The study hypothesis is that LB is not unacceptably worse than CISB with regard to pain control in the first two postoperative days.
Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and investigator) and a 1:1 ratio to receive either LB or CISB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Liposomal bupivacaine
Patients will receive a single bolus interscalene injection of 10mL 1.33% LB followed by placement of indwelling (sham) catheter in the interscalene region. Upon arrival in the recovery room, a nurse will connect the catheter to a fixed-rate portable elastometric pump (Easypump®, B Braun, Germany) filled with 300mL normal saline (NS) at a default fixed rate of infusion of 5mL/hr. The syringe, catheter, pump and clamp will be covered by opaque black bags to conceal the milky appearance of LB. The catheter will be removed on postoperative day 2.
Liposomal bupivacaine
Single bolus injection 10mL 1.33% LB
Standard bupivacaine CISB
Patients will receive a single bolus interscalene injection of 10mL 0.25% SB followed by placement of indwelling (sham) catheter in the interscalene region. Upon arrival in the recovery room, a nurse will connect the catheter to a fixed-rate portable elastometric pump (Easypump®, B Braun, Germany) filled with 300mL 0.2% SB at a default fixed rate of infusion of 5mL/hr. The syringe, catheter, pump and clamp will be covered by opaque black bags to conceal the drug appearance. The catheter will be removed on postoperative day 2.
Standard bupivacaine
Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr
Interventions
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Liposomal bupivacaine
Single bolus injection 10mL 1.33% LB
Standard bupivacaine
Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 80
* Isolated Proximal humeral fracture (AO Types 31.A1-3 and B1-3 or Neer 2/3 part or greater tuberosity fracture equivalent)
* Locking Plate fixation
* Split deltoid minimal invasive approach
Exclusion Criteria
* Impaired cognitive function (Abbreviated Mental Test Score (AMT score) \< 8)
* 4 part fractures
* Poor surgical reduction quality
* Unable to attend rehabilitation
* Preexisting shoulder problems
* Fracture fixation stability unable to tolerate early passive motion exercise
* Use of implants other than a locking plate for fracture fixation
* Activity of daily living is dependent on others
* Polytrauma
* Use of deltopectoral approach
* Patient unable to follow post-operative rehabilitation protocol with early mobilization
* 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, nicomorphine, oxycodone, or meperidine)
* 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
* Patients do not understand Cantonese
18 Years
80 Years
ALL
Yes
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Chan Chi-Wing
Honorary Clinical Associate Professor
Principal Investigators
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Chi Wing Chan
Role: PRINCIPAL_INVESTIGATOR
Queen Mary Hospital, Hong Kong
Christian Xinshuo Fang
Role: PRINCIPAL_INVESTIGATOR
Queen Mary Hospital, Hong Kong
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Hodgson SA, Mawson SJ, Stanley D. Rehabilitation after two-part fractures of the neck of the humerus. J Bone Joint Surg Br. 2003 Apr;85(3):419-22. doi: 10.1302/0301-620x.85b3.13458.
Vorobeichik L, Brull R, Bowry R, Laffey JG, Abdallah FW. Should continuous rather than single-injection interscalene block be routinely offered for major shoulder surgery? A meta-analysis of the analgesic and side-effects profiles. Br J Anaesth. 2018 Apr;120(4):679-692. doi: 10.1016/j.bja.2017.11.104. Epub 2018 Feb 13.
Malik O, Kaye AD, Kaye A, Belani K, Urman RD. Emerging roles of liposomal bupivacaine in anesthesia practice. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):151-156. doi: 10.4103/joacp.JOACP_375_15.
Sabesan VJ, Shahriar R, Petersen-Fitts GR, Whaley JD, Bou-Akl T, Sweet M, Milia M. A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. J Shoulder Elbow Surg. 2017 Oct;26(10):1810-1817. doi: 10.1016/j.jse.2017.06.044. Epub 2017 Aug 24.
Budge M, Orvets N, Shields E. Single-shot liposomal bupivacaine interscalene nerve block provides equivalent pain relief compared to continuous catheter interscalene nerve block in total shoulder arthroplasty. Seminars in Arthroplasty: JSES. 2020;30(4):285-90.
Marino J, Scuderi G, Dowling O, Farquhar R, Freycinet B, Overdyk F. Periarticular Knee Injection With Liposomal Bupivacaine and Continuous Femoral Nerve Block for Postoperative Pain Management After Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):495-500. doi: 10.1016/j.arth.2018.11.025. Epub 2018 Nov 23.
Weller WJ, Azzam MG, Smith RA, Azar FM, Throckmorton TW. Liposomal Bupivacaine Mixture Has Similar Pain Relief and Significantly Fewer Complications at Less Cost Compared to Indwelling Interscalene Catheter in Total Shoulder Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3557-3562. doi: 10.1016/j.arth.2017.03.017. Epub 2017 Mar 16.
Other Identifiers
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UW 20-247
Identifier Type: -
Identifier Source: org_study_id