Continuous Standard Bupivacaine Interscalene Block Versus Single Injection Liposomal Bupivacaine Following Surgical Fixation of Proximal Humerus Fractures
试验速览
- 阶段
- 3 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Pain on movement as measured by Numerical Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Subjects, investigators, and all parties involved in patient management or data collection will be blinded throughout the study period.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard bupivacaine CISB
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.
干预措施: Standard bupivacaine (Drug)
Liposomal bupivacaine
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.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Pain on movement as measured by Numerical Rating Scale (NRS)
时间窗: 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)
时间窗: At each post-op day 1-7
Numerical rating scale (NRS) at rest; 0 points (no pain) to 11 points (worst pain imaginable).
次要结局
- Intraoperative opioid consumption(Intraoperative)
- Incidence of ISB related complications(Intraoperative to post-op day 3)
- PCA morphine consumption(From immediately post-operation to post-op day 2)
- Presence of neuropathic pain at follow-up(At post-op 2 weeks, 6 weeks and 3 months)
- Region-specific physical functioning and symptoms(At post-op 2 weeks, 6 weeks and 3 months)
- Number of patients with side effects effects of PCA using morphine(From immediately post-operation to post-op day 2)
- Rescue morphine consumption(From immediately post-operation to post-op day 2)
- Total length of stay(Through study completion, an average of 1 year)
- Analgesic consumption after discharge(From post-op day 3 to day 7)
- Overall Benefit of Analgesia Score (OBAS)(Immediate post-operation to post-op day 3)
- Health-related quality of life (HRQOL)(At post-op 2 weeks, 6 weeks and 3 months)
- Presence of chronic pain at follow-up(At 2 weeks, 6 weeks and 3 months post-op)
- Patient satisfaction as measured by the Patient Satisfaction Questionnaire General Satisfaction Subscale(At post-op 2 weeks, 6 weeks and 3 months)
研究者
Dr. Chan Chi-Wing
Honorary Clinical Associate Professor
The University of Hong Kong