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

  • STATUS
    Recruiting
  • participants needed
    78
  • sponsor
    The University of Hong Kong
Updated on 9 August 2022
analgesia
humeral fracture

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.

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.

An aseptic technique will be applied. ISB will be performed under ultrasound guidance in an in-plane manner. Catheter-over-needle set with a 50mm short-bevel insulated needle will be used.

Placement of needle will be confirmed with sonoanatomy, absence of persistent paraesthesia, negative aspiration of air and blood, real-time visualisation of the spread of drug and low resistance upon injection. The catheter will be left in-situ and sutured to the skin after injection of the drug and withdrawal of the needle.

Neither the supraclavicular nerve nor the suprascapular nerve will be blocked.

The use of a peripheral nerve stimulator and administration of sedation will be at the discretion of the attending anaesthetist.

A successful ISB is defined as loss of cold sensation to ice in the C5 dermatome, which will be tested by the attending anaesthetist in addition to assessing the presence of aforementioned complications before induction of general anaesthesia.

ANAESTHESIA & ANALGESIA:

(I) PRE-OPERATIVE:

Routine preoperative assessment will be taken at the pre-admission clinic or at the general ward, followed by these orders:

ECG and chest x-ray Standard fasting times (6 hours for solid food and 2 hours for clear liquid) No analgesics or sedatives as premedication

(II) INTRA-OPERATIVE: ISB will be performed as described above before induction of General Anaesthesia (GA).

For Induction of GA:

IV Fentanyl 2mcg/kg IV Propofol 2-4 mg/kg Choice of muscle relaxant at the discretion of the attending anaesthetist

For Maintenance of GA:

Air/O2/desflurane, target MAC: 0.6 -1.0 IV Morphine 3mg before skin incision IV Remifentanil 0.1-0.2 mcg/kg/min, target SBP not more than 20% increase from baseline Choice of muscle relaxant and IV fluid at the discretion of the attending anaesthetist Vasopressors, anti-hypertensive medications, anti-arrhythmia medications may be given as necessary No Paracetamol / NSAID / Ketamine / Dexmedetomidine / IV Lidocaine infusion / Magnesium No LA infiltration

For Emergence from GA:

IV Ondansetron 4mg Reversal agents may be given

(III) POST-OPERATIVE (PHASE I RECOVERY IN PACU): All subjects will be transferred to PACU for further monitoring for at least 30 minutes.

The indwelling catheter will be connected to a fixed-rate portable elastometric pump ( Easy pump, ®) upon arrival in the recovery room by the nurse.

Pain at rest will be evaluated every 5 mins using NRS. If the score is greater than 4/10, 2mg morphine will be given intravenously every 5 mins provided the subject has a respiratory rate of > 12/min and a sedation score of <1 until a NRS of < 4/10 is achieved.

The presence of complications will be assessed by the attending anaesthetist before discharge from PACU.

(IV) POST-OPERATIVE (PHASE II IN WARD): BP, heart rate, SpO2, and sedation score will be monitored at 1-hour intervals while on PCA morphine; BP and heart rate will be monitored at 4-hour intervals once PCA morphine is terminated.

Diet will be resumed on Post-Operative Day 0. All subjects will undergo standard institutional rehabilitation program, which consists of supervised passive forward flexion and external rotation exercise for 3 weeks, followed by assisted active movements till 6 weeks.

Standardized analgesic regime will be prescribed:

IV PCA morphine for 2 days PO paracetamol 500mg QID for 1 week PO celecoxib 200mg daily for 1 week IMI morphine 0.1mg/kg Q4H prn as rescue analgesic for 5 days IV ondansetron 0.1mg/kg Q8H prn for 5 days PO Dihydroxycodeine 30mg QID prn for 1 week upon discharge

Signs and symptoms of complications will be assessed by the pain team daily until postoperative day 2 when the pump and catheter will be removed. Pain assessment and side effects related to analgesic will be assessed by the pain team daily until postoperative day 2, followed by phone follow-up until postoperative day 7

For phone follow-up, patients will be received a phone call in the afternoon at around 3 pm for both pain score and Overall Benefit of Analgesic Scale (OBAS)

Details
Condition Shoulder Fractures
Treatment Liposomal bupivacaine, Standard Bupivacaine
Clinical Study IdentifierNCT04928664
SponsorThe University of Hong Kong
Last Modified on9 August 2022

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