Continuous vs Liposomal Bupivacaine Interscalene Block for Proximal Humeral Fracture (CLIP)

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• ASA I-III

• Age between 18 and 80

• Proximal humeral fracture

Exclusion Criteria:

• Surgical exclusion criteria:

• Revision surgery

• 4 parts 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, dicomorphine, 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

• Patients do not understand Cantonese or Mandarin