Clinical trial NCT05084573: Continuous Interscalene Block vs Liposomal Bupivacaine After Proximal Humerus Fracture Surgery
Official title: Continuous Standard Bupivacaine Interscalene Block Versus Single Injection Liposomal Bupivacaine Following Surgical Fixation of Proximal Humerus Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Shoulder Fractures
Keywords: interscalene nerve block
shoulder surgery
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be allocated to receive either continuous interscalene nerve block (CISB) using standard bupivacaine OR a single interscalene injection of liposomal bupivacaine (LB).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain on movement as measured by Numerical Rating Scale (NRS)
timeFrame: At each post-op day 1-7
measure: Pain at rest as measured by Numerical Rating Scale (NRS)
timeFrame: At each post-op day 1-7
Secondary outcomes:
measure: Intraoperative opioid consumption
timeFrame: Intraoperative
measure: Incidence of ISB related complications
timeFrame: Intraoperative to post-op day 3
measure: PCA morphine consumption
timeFrame: From immediately post-operation to post-op day 2
measure: Number of patients with side effects effects of PCA using morphine
timeFrame: From immediately post-operation to post-op day 2
measure: Rescue morphine consumption
timeFrame: From immediately post-operation to post-op day 2
measure: Total length of stay
timeFrame: Through study completion, an average of 1 year
measure: Analgesic consumption after discharge
timeFrame: From post-op day 3 to day 7
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: Immediate post-operation to post-op day 3
measure: Presence of chronic pain at follow-up
timeFrame: At 2 weeks, 6 weeks and 3 months post-op
measure: Presence of neuropathic pain at follow-up
timeFrame: At post-op 2 weeks, 6 weeks and 3 months
measure: Region-specific physical functioning and symptoms
timeFrame: At post-op 2 weeks, 6 weeks and 3 months
measure: Health-related quality of life (HRQOL)
timeFrame: At post-op 2 weeks, 6 weeks and 3 months
measure: Patient satisfaction as measured by the Patient Satisfaction Questionnaire General Satisfaction Subscale
timeFrame: At post-op 2 weeks, 6 weeks and 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Chi Wing Chan
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary Hospital, Hong Kong
name: Christian Xinshuo Fang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
citation: 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.
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.
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.