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The purpose of this study is to compare the efficacy of continuous interscalene block (CISB) using standard bupivacaine versus a single interscalene injection of liposomal bupivacaine (LB) on pain control following surgical fixation of proximal humerus fractures.
Restricted range of motion following open reduction and internal fixation (ORIF) of proximal humerus fractures is a potential complication that severely limits functional outcomes . It must therefore be avoided by adequate pain control in order to allow for early mobilisation in addition to physiotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine | Experimental | 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. |
|
| Standard bupivacaine CISB | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Single bolus injection 10mL 1.33% LB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain on movement as measured by Numerical Rating Scale (NRS) | Numerical rating scale (NRS) during attempted passive forward shoulder flexion to 90 degrees; 0 points (no pain) to 11 points (worst pain imaginable). | At each post-op day 1-7 |
| Pain at rest as measured by Numerical Rating Scale (NRS) | Numerical rating scale (NRS) at rest; 0 points (no pain) to 11 points (worst pain imaginable). | At each post-op day 1-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative opioid consumption | Intraoperative IV remifentanil consumption (mcg/kg/min) | Intraoperative |
| Incidence of ISB related complications | Complications related to interscalene block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Wing Chan | Contact | 22551740 | timmychancw@gmail.com | |
| Christian Xinshuo Fang | Contact | 22554581 | fangcx@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chi Wing Chan | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Christian Xinshuo Fang | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12729121 | Background | 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. | |
| 29576109 | Background | 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. |
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De-identified dataset underlying results to be published as an appendix in final publication.
Aim to publish protocol and analysis plan in a peer-reviewed journal prior to recruitment completion
Additional information available upon reasonable request of the corresponding author.
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Patients will be allocated to receive either continuous interscalene nerve block (CISB) using standard bupivacaine OR a single interscalene injection of liposomal bupivacaine (LB).
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Subjects, investigators, and all parties involved in patient management or data collection will be blinded throughout the study period.
| Standard bupivacaine | Drug | Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr |
|
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| Intraoperative to post-op day 3 |
| PCA morphine consumption | Amount of patient-controlled analgesia (PCA) morphine consumed (mg) | From immediately post-operation to post-op day 2 |
| Number of patients with side effects effects of PCA using morphine | Side effects related to opioid use (Nausea/Vomiting, Dizziness, Constipation) | From immediately post-operation to post-op day 2 |
| Rescue morphine consumption | Additional opioid used in addition to PCA morphine | From immediately post-operation to post-op day 2 |
| Total length of stay | Duration of hospital stay (days) | Through study completion, an average of 1 year |
| Analgesic consumption after discharge | Total analgesic consumption (dihydrocodeine) after hospital discharge (pill count) | From post-op day 3 to day 7 |
| Overall Benefit of Analgesia Score (OBAS) | Patient-reported measure of pain, side effects, and satisfaction of post-operative analgesia; 7 questions rated from 0 (worst outcome) to 4 (best outcome) | Immediate post-operation to post-op day 3 |
| Presence of chronic pain at follow-up | Presence of chronic pain by self-report | At 2 weeks, 6 weeks and 3 months post-op |
| Presence of neuropathic pain at follow-up | Presence of neuropathic pain by physical examination and neuropathic pain questionnaire, a 10-item mixed self-report/observer rated physical exam measure ranging from 0 (no pain) to 10, with a score of 4 or greater diagnostic of neuropathic pain | At post-op 2 weeks, 6 weeks and 3 months |
| Region-specific physical functioning and symptoms | Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability). | At post-op 2 weeks, 6 weeks and 3 months |
| Health-related quality of life (HRQOL) | 12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome). | At post-op 2 weeks, 6 weeks and 3 months |
| Patient satisfaction as measured by the Patient Satisfaction Questionnaire General Satisfaction Subscale | Patient satisfaction with healthcare provision as measured by the Patient Satisfaction Questionnaire General Satisfaction subscale (PSQ18-GS), a two-item subscale with a final score ranging from 0 (lowest satisfaction) to 10 (highest satisfaction) | At post-op 2 weeks, 6 weeks and 3 months |
| 28781438 | Background | 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. |
| 28844420 | Background | 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. |
| Background | 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. |
| 30583813 | Background | 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. |
| 28390888 | Background | 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. |
| D000588 |
| Amines |