Continuous vs Liposomal Bupivacaine Interscalene Block for Proximal Humeral Fracture (CLIP)
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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. Although prolonged analgesic effects of LB over Normal Saline (NS)
have long been demonstrated in numerous studies, the effectiveness of LB infiltration
compared to SB cannot be consistently demonstrated in general surgery. Similar inferior
analgesia of infiltrated LB has been documented in RCTs involving knee and shoulder surgery
for both single-injection and continuous nerve blocks.
In contrast, adding LB to SB in ISB lowered the worst pain scores in the first postoperative
week with major shoulder surgery compared to using SB alone. To date, no studies have
examined the effectiveness of LB in ISB compared to continuous nerve block for shoulder
surgery or ORIF of proximal humeral fractures.