Shoulder Fractures
Conditions
Keywords
interscalene nerve block, shoulder surgery
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.
Interventions
DRUGLiposomal bupivacaine
Single bolus injection 10mL 1.33% LB
Single bolus 10mL 0.25% SB + continuous 300mL 0.2% SB @5mL/hr
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Subjects, investigators, and all parties involved in patient management or data collection will be blinded throughout the study period.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on movement as measured by Numerical Rating Scale (NRS) | At each post-op day 1-7 | Numerical rating scale (NRS) during attempted passive forward shoulder flexion to 90 degrees; 0 points (no pain) to 11 points (worst pain imaginable). |
| Pain at rest as measured by Numerical Rating Scale (NRS) | At each post-op day 1-7 | Numerical rating scale (NRS) at rest; 0 points (no pain) to 11 points (worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCA morphine consumption | From immediately post-operation to post-op day 2 | Amount of patient-controlled analgesia (PCA) morphine consumed (mg) |
| Number of patients with side effects effects of PCA using morphine | From immediately post-operation to post-op day 2 | Side effects related to opioid use (Nausea/Vomiting, Dizziness, Constipation) |
| Rescue morphine consumption | From immediately post-operation to post-op day 2 | Additional opioid used in addition to PCA morphine |
| Total length of stay | Through study completion, an average of 1 year | Duration of hospital stay (days) |
| Analgesic consumption after discharge | From post-op day 3 to day 7 | Total analgesic consumption (dihydrocodeine) after hospital discharge (pill count) |
| Intraoperative opioid consumption | Intraoperative | Intraoperative IV remifentanil consumption (mcg/kg/min) |
| Presence of chronic pain at follow-up | At 2 weeks, 6 weeks and 3 months post-op | Presence of chronic pain by self-report |
| Presence of neuropathic pain at follow-up | At post-op 2 weeks, 6 weeks and 3 months | 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 |
| Region-specific physical functioning and symptoms | At post-op 2 weeks, 6 weeks and 3 months | 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). |
| Health-related quality of life (HRQOL) | At post-op 2 weeks, 6 weeks and 3 months | 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). |
| Patient satisfaction as measured by the Patient Satisfaction Questionnaire General Satisfaction Subscale | At post-op 2 weeks, 6 weeks and 3 months | 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) |
| Overall Benefit of Analgesia Score (OBAS) | Immediate post-operation to post-op day 3 | Patient-reported measure of pain, side effects, and satisfaction of post-operative analgesia; 7 questions rated from 0 (worst outcome) to 4 (best outcome) |
| Incidence of ISB related complications | Intraoperative to post-op day 3 | Complications related to interscalene block |
Countries
Hong Kong
Contacts
Primary ContactChi Wing Chan
Backup ContactChristian Xinshuo Fang
Outcome results
None listed