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
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: a Randomized Controlled 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Stanley S.C. Wong
- Telefonnummer: (852) 2255 3303
- E-mail: wongstan@hku.hk
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- Queen Mary Hospital
-
Kontakt:
- Stanley S.C. Wong
- Telefonnummer: (852) 2255 3303
- E-mail: wongstan@hku.hk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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
Patients identified to be at an elevated risk of suffering from poor postoperative pain control. Patients with one or more of the following risk factors:
- Severe preoperative pain: defined as worse numerical rating scale (NRS) pain score equal or higher than 6/10 with arm movements at day before surgery.
- Preoperative use of opioid: use of strong opioids such as morphine, oxycodone
- Depressive symptoms: Patient health questionnaire (PHQ-9) score of 10 or above
- Anxiety symptoms: General Anxiety Disorder (GAD-7) score of 10 or above
- Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
Exclusion Criteria:
- 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
- Respiratory compromise (requires long term oxygen)
- History of seizures
- Pre-existing neurological disorder/deficit
- Alcohol or substance abuse
- Impaired mental state
- Local infection
- Allergy to analgesic drugs: local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids
- Impaired renal function (defined as effective glomerular filtration rate < 30ml/min/1.73m2
- Impaired liver function (defined as plasma bilirubin over 34μmol/L; international normalized ratio [INR] ≥1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
- Coagulopathy (platelet count <100,000/ml and/or INR ≥ 1.5) or the use of anticoagulants (not including aspirin) that precludes the use of supraclavicular BPB
- Pregnancy
- Patient refusal for regional nerve blocks
- Patient refusal to join the clinical trial
- Patient unable/unwilling to attend post-op rehabilitation programme
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: SBPB using 10ml 0.5% plain bupivacaine with 10ml 1.33% liposomal bupivacaine (LP-BPB)
Supraclavicular brachial plexus block with 10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine
|
10ml 0.5% plain bupivacaine plus 10ml 1.33% liposomal bupivacaine (133mg)
|
|
Eksperimentel: SBPB using 19ml 0.5% plain bupivacaine with 1ml (4mg) dexamethasone (D-BPB)
Supraclavicular brachial plexus block using 19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone
|
19ml 0.5% plain bupivacaine plus 1ml (4mg) dexamethasone
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weighted area under curve (AUC) pain score with movement
Tidsramme: The first 48 hours after surgery
|
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.
|
The first 48 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
NRS pain scores
Tidsramme: Postoperative day 0-7
|
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)
|
Postoperative day 0-7
|
|
Overall Benefit of Analgesic Score (OBAS)
Tidsramme: Postoperative day 0-7
|
Overall Benefit of Analgesic Score (OBAS) will be assessed once a day until POD 7 (range, 0 [best] to 28 [worst]).
|
Postoperative day 0-7
|
|
Acute postoperative opioid consumption
Tidsramme: Postoperative day0-7
|
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.
|
Postoperative day0-7
|
|
Sleep disturbance
Tidsramme: Postoperative day0-7
|
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).
|
Postoperative day0-7
|
|
Quality of recovery (QoR)
Tidsramme: Postoperative day0-7
|
This will be accessed using the Quality of recovery (QoR) questionnaire.
(range from 0 to 18, where 0 represent the worst quality of recovery and 18 represent the best quality of recovery)
|
Postoperative day0-7
|
|
Adverse effects related to supraclavicular BPB
Tidsramme: postoperative day0-2
|
The potential side effects related to the supraclavicular BPB will be recorded.
|
postoperative day0-2
|
|
Opioid related side effects
Tidsramme: postoperative day0-7
|
Opioid related side effects will be recorded.
|
postoperative day0-7
|
|
Analgesic block duration.
Tidsramme: On postoperative day1
|
Time to return of pain, time to sensory resolution, time to motor resolution will be recorded on POD 1.
|
On postoperative day1
|
|
Sensory and motor assessment of the affected upper limb
Tidsramme: Postoperative day0-1
|
Sensation to pin prick will be tested over the following areas: C5 (lateral shoulder), C6 (thumb), C7 (3rd finger), and C8 (4th finger) dermatomes.
Motor assessment will be done by recording grip strength and bicep contraction.
Sensation will be rated as 0-10 , where 0 represent no sensation and 10 represent normal sensation.
Motor function will be rated as 0 (paralysis), 1 (paresis), 2 (normal power).
|
Postoperative day0-1
|
|
Health related quality of life
Tidsramme: Baseline and at 3, 6 and 12 weeks after surgery
|
Health related quality of life will be assessed using the SF-12v2.
Baseline scores will be obtained before surgery.
The SF-12v2 will produce two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Both summary scores range from 0 to 100, where higher scores always indicate better physical and mental health.
|
Baseline and at 3, 6 and 12 weeks after surgery
|
|
Upper limb functional scores.
Tidsramme: Baseline and at 3, 6 and 12 weeks after surgery
|
The validated Chinese versions of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) will be used to assess upper limb functional scores.
Baseline scores will be obtained before surgery.
(Range from 0 to 100, a lower score indicates a better outcome)
|
Baseline and at 3, 6 and 12 weeks after surgery
|
|
Hand grip power of normal and injured side
Tidsramme: At 3, 6 and 12 weeks after surgery
|
Hand grip power of normal and injured side will be assessed (both hands).
|
At 3, 6 and 12 weeks after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Postoperative komplikationer
- Patologiske processer
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerte
- Smerter, postoperativ
- Polycykliske forbindelser
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Dexamethason
Andre undersøgelses-id-numre
- UW 25-516
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .