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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
92
Single bolus injection 10mL 1.33% LB
Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr
Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGPain 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).
Time frame: 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).
Time frame: At each post-op day 1-7
Intraoperative opioid consumption
Intraoperative IV remifentanil consumption (mcg/kg/min)
Time frame: Intraoperative
Incidence of ISB related complications
Complications related to interscalene block
Time frame: Intraoperative to post-op day 3
PCA morphine consumption
Amount of patient-controlled analgesia (PCA) morphine consumed (mg)
Time frame: 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)
Time frame: From immediately post-operation to post-op day 2
Rescue morphine consumption
Additional opioid used in addition to PCA morphine
Time frame: From immediately post-operation to post-op day 2
Total length of stay
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Duration of hospital stay (days)
Time frame: Through study completion, an average of 1 year
Analgesic consumption after discharge
Total analgesic consumption (dihydrocodeine) after hospital discharge (pill count)
Time frame: 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)
Time frame: Immediate post-operation to post-op day 3
Presence of chronic pain at follow-up
Presence of chronic pain by self-report
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: At post-op 2 weeks, 6 weeks and 3 months