Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery

Shoulder Fractures Clinical Trial

— CLIP-H  

Official title:

Continuous Standard Bupivacaine Interscalene Block Versus Single Injection Liposomal Bupivacaine Following Surgical Fixation of Proximal Humerus Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084573
• Other study ID #: UW 20-247
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2021
• Source: The University of Hong Kong
• Contact: Chi Wing Chan
• Phone: 22551740
• Email: timmychancw[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: March 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA I-III

• 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:

• Revision surgery

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fractures

Intervention

Drug:
• Liposomal bupivacaine
Single bolus injection 10mL 1.33% LB
• Standard bupivacaine
Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

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.

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Intraoperative opioid consumption	Intraoperative IV remifentanil consumption (mcg/kg/min)	Intraoperative
Secondary	Incidence of ISB related complications	Complications related to interscalene block	Intraoperative to post-op day 3
Secondary	PCA morphine consumption	Amount of patient-controlled analgesia (PCA) morphine consumed (mg)	From immediately post-operation to post-op day 2
Secondary	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
Secondary	Rescue morphine consumption	Additional opioid used in addition to PCA morphine	From immediately post-operation to post-op day 2
Secondary	Total length of stay	Duration of hospital stay (days)	Through study completion, an average of 1 year
Secondary	Analgesic consumption after discharge	Total analgesic consumption (dihydrocodeine) after hospital discharge (pill count)	From post-op day 3 to day 7
Secondary	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
Secondary	Presence of chronic pain at follow-up	Presence of chronic pain by self-report	At 2 weeks, 6 weeks and 3 months post-op
Secondary	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
Secondary	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
Secondary	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
Secondary	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