Continuous Standard Bupivacaine Versus Single Liposomal Bupivacaine Injection for Interscalene Brachial Plexus Block for Pain Management After Proximal Humerus Fracture Fixation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Weighted area under curve (AUC) pain score at rest
Study Overview
Brief Summary
Restricted range of shoulder motion following ORIF is a potential complication that severely affects the patients' functional outcome and should be actively avoided by means of adequate pain control in addition to early mobilization and physiotherapy.
Peripheral nerve blocks, which can be given as a single injection or continuous infusion via an indwelling catheter, are analgesic options to be considered. Interscalene Block (ISB) is the regional analgesia of choice for the shoulder and proximal humerus region. While continuous infusion (aka continuous nerve block) offers the advantage of a longer duration of analgesia compared to a single injection of standard local anaesthetic, it is associated with an inherent risk of catheter displacement, dislodgement, obstruction, and infection.
Compared to Standard Bupivacaine (SB), Liposomal Bupivacaine (LB) is a formulation designed to prolong the duration of action to up to 72 hours by slow release of bupivacaine from the multi-vesicular liposomes. Several studies have demonstrated satisfactory analgesic effects of liposomal bupivacaine given as local surgical site infiltration over placebo. However, the effects of single injection of liposomal bupivacaine given via local surgical site infiltration compared to continuous nerve block have been inconsistent. Administrating liposomal bupivacaine directly to peripheral nerve blocks is a potentially effective approach that has not been extensively studied. ISB with single shot liposomal bupivacaine has been shown to provide superior postoperative analgesia compared to ISB with injection of standard bupivacaine or placebo. ISB with liposomal bupivacaine could perhaps prolong and improve postoperative analgesia without the potential problems with continuous nerve blocks. The analgesic effect of ISB with single shot liposomal bupivacaine versus continuous ISB with standard bupivacaine has not been previously investigated. The aim of this study is to compare the analgesic effect of these two analgesic modalities for plate fixation of proximal humerus fractures.
Detailed Description
CONDUCT OF ISB:
Side effects and potential complications will be explained and informed consent will be obtained from all subjects.
Time-out will be performed before the start of ISB in accordance with the WHO checklist, confirming the side of surgery with the subject.
Standard monitoring will be placed and an intravenous catheter will be established.
All ISB will be performed by anaesthetists experienced in ultrasound-guided ISB.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
The subjects, the investigators, and all the parties involved in patient management or data collection will be blinded throughout the study period.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA I-III
- •Age between 18 and 80
- •Proximal humeral fracture
Exclusion Criteria
- •Surgical exclusion criteria:
- •Revision surgery
- •Pathological fracture
- •4-part or shaft fracture
- •Multiple fractures
- •Unable to attend rehabilitation
- •Preexisting shoulder problems
- •Abbreviated Mental Test Score (AMT score) < 8
- •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, diamorphine, oxycodone, or meperidine) before operation
- •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
Arms & Interventions
Liposoaml Bupivacaine (LB) Group
Intervention group
Intervention: Liposomal bupivacaine (Drug)
Standard Bupivacaine (SB) Group
Control group
Intervention: Standard bupivacaine (Drug)
Outcomes
Primary Outcomes
Weighted area under curve (AUC) pain score at rest
Time Frame: 0-48 hours after surgery
Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Chan Chi-Wing
Honorary Clinical Associate Professor
The University of Hong Kong