Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe University of Hong Kong

About this trial

The supraclavicular brachial plexus block (BPB) is a frequently used anaesthetic method for upper limb surgeries, including distal radial fracture surgery. Adding liposomal bupivacaine to BPB has shown promise in enhancing postoperative pain control. A previous randomized controlled trial demonstrated that it reduced pain scores and OBAS compared to plain bupivacaine alone, especially on postoperative day (POD) 1. Adding adjuncts to non-liposomal local anaesthetics can also enhance and prolong postoperative pain relief. The effectiveness of liposomal bupivacaine compared to adjuncts like dexamethasone and dexmedetomidine remains unclear. Since liposomal bupivacaine is more expensive, it is crucial to compare its analgesic efficacy with these alternatives. A randomized controlled trial comparing liposomal bupivacaine versus dexamethasone in the interscalene BPB for shoulder surgery found that liposomal bupivacaine resulted in statistically significantly lower pain scores and less pain interference in the Brief Pain Inventory, although the reduction was not considered clinically relevant. Its high cost may therefore limit its routine use unless specific clinical contexts where its efficacy is maximized are identified. Notably, patients with risk factors like psychological factors, preoperative pain, and prior analgesic use may benefit most from its application.

A randomized controlled trial to compare the analgesic efficacy of liposomal bupivacaine plus plain bupivacaine versus dexamethasone plus plain bupivacaine in supraclavicular BPB for patients at higher risk of poor acute pain control post distal radial fracture surgery will be conducted. Patients with severe preoperative pain, opioid use, depressive symptoms, anxiety symptoms, and/or higher energy and high-grade fracture cases will be selected. The primary outcome measured is the intensity of acute postoperative pain with movement in the first 48 hours after surgery. Important secondary outcomes include pain intensity at rest, opioid consumption, OBAS scores, chronic pain, and upper limb functionality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologist (ASA) status I-III

Age 18-90 years old

Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)

Informed consent obtained

Disqualifiers

Revision surgery

Previous fractures or surgery in the affected distal radius

Surgery involving more than the affected arm

Cases with baseline (pre-injury) QuickDASH score worse (higher) than 10 out of 100

Trial design

Design model

Parallel

Treatments tested in this trial

  • 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine

    Drug

    10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine (133mg)

  • 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone

    Drug

    19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB)Active comparator 1 intervention
Group B: SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weighted area under curve (AUC) pain score with movement

The weighted area under curve (AUC) numerical rating scale (NRS) pain score with movement (active wrist flexion and extension) from 0-48 hours after distal radial fracture surgery.

Time frame
The first 48 hours after surgery

Secondary outcomes

1

NRS pain scores

NRS pain scores both at rest and with movement will be assessed from after surgery to POD 7. (NRS scale 0-10, where 0 is no pain, and 10 is the worst possible pain)

Time frame
Postoperative day 0-7
2

Overall Benefit of Analgesic Score (OBAS)

Overall Benefit of Analgesic Score (OBAS) will be assessed once a day until POD 7 (range, 0 \[best\] to 28 \[worst\]).

Time frame
Postoperative day 0-7
3

Acute postoperative opioid consumption

The daily consumption of oxycodone in the ward and after discharge will be recorded. The dose of rescue intravenous morphine consumption in the PACU will also be recorded.

Time frame
Postoperative day0-7
4

Sleep disturbance

Sleep disturbance due to pain will be evaluated once a day till POD 7 (0-10, where 0 represents no disturbance and 10 represents the most disturbance possible).

Time frame
Postoperative day0-7

Other outcomes

Sponsors and contacts

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