Clinical trial NCT05359731: Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
Official title: Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Acute Pain
Upper Extremity Injury
Keywords: Dexamethasone
Nerve Block
Adjuvant
Pharmacokinetic Analysis
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone.

The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD).

Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification 1-2
* Real weight between 80 and 100 kg
* Body mass index between 20 and 30

Exclusion Criteria:

* Adults who are not capable of giving their own consent
* Medical history or physical findings of pre-existing neuropathy
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs)
* Pregnancy
* Previous surgery in the axillary region of the surgical side

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of bupivacaine
timeFrame: 0 to 90 minutes after the ending time of local anesthetic injection
Secondary outcomes:
measure: Plasmatic concentration of bupivacaine at 15 minutes
timeFrame: 15 minutes after the ending time of local anesthetic injection
measure: Plasmatic concentration of bupivacaine at 30 minutes
timeFrame: 30 minutes after the ending time of local anesthetic injection
measure: Plasmatic concentration of bupivacaine at 45 minutes
timeFrame: 45 minutes after the ending time of local anesthetic injection
measure: Plasmatic concentration of bupivacaine at 60 minutes
timeFrame: 60 minutes after the ending time of local anesthetic injection
measure: Plasmatic concentration of bupivacaine at 90 minutes
timeFrame: 90 minutes after the ending time of local anesthetic injection
measure: Time to obtain the maximum plasma concentration of bupivacaine (Tmax)
timeFrame: 0 to 90 minutes after the ending time of local anesthetic injection
measure: Area under the curve of plasma concentration versus time at 90 minutes (AUC90)
timeFrame: 0 to 90 minutes after the ending time of local anesthetic injection
measure: Sensory and motor block score
timeFrame: 30 minutes after the ending time of local anesthetic injection
measure: Block onset time
timeFrame: 30 minutes after the ending time of local anesthetic injection
measure: Incidence of successful block
timeFrame: 30 minutes after the ending time of local anesthetic injection
measure: Motor block duration
timeFrame: 48 hours after the ending time of local anesthetic injection
measure: Sensory block duration
timeFrame: 48 hours after the ending time of local anesthetic injection
measure: Analgesic block duration
timeFrame: 48 hours after the ending time of local anesthetic injection
measure: Intensity of pain during block procedure
timeFrame: During the execution of the nerve blockade
measure: Block performance time
timeFrame: From the skin anesthesia to the end of local anesthetic injection
measure: Incidence of nerve block side effects
timeFrame: From the skin anesthesia to the end of local anesthetic injection
measure: Persistent neurologic deficit
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitan
Study officials:
References:
citation: Desai N, Albrecht E, El-Boghdadly K. Perineural adjuncts for peripheral nerve block. BJA Educ. 2019 Sep;19(9):276-282. doi: 10.1016/j.bjae.2019.05.001. Epub 2019 Jul 6. No abstract available.
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citation: Kirkham KR, Jacot-Guillarmod A, Albrecht E. Optimal Dose of Perineural Dexamethasone to Prolong Analgesia After Brachial Plexus Blockade: A Systematic Review and Meta-analysis. Anesth Analg. 2018 Jan;126(1):270-279. doi: 10.1213/ANE.0000000000002488.
citation: Souza MCO, Marques MP, Duarte G, Lanchote VL. Analysis of bupivacaine enantiomers in plasma as total and unbound concentrations using LC-MS/MS: Application in a pharmacokinetic study of a parturient with placental transfer. J Pharm Biomed Anal. 2019 Feb 5;164:268-275. doi: 10.1016/j.jpba.2018.10.040. Epub 2018 Oct 23.
citation: Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.
citation: Bravo D, Aliste J, Layera S, Fernandez D, Leurcharusmee P, Samerchua A, Tangjitbampenbun A, Watanitanon A, Arnuntasupakul V, Tunprasit C, Gordon A, Finlayson RJ, Tran DQ. A multicenter, randomized comparison between 2, 5, and 8 mg of perineural dexamethasone for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2019 Jan;44(1):46-51. doi: 10.1136/rapm-2018-000032.
citation: Ferraro LHC, Takeda A, Barreto CN, Faria B, Assuncao NA. [Pharmacokinetic and clinical effects of two bupivacaine concentrations on axillary brachial plexus block]. Braz J Anesthesiol. 2018 Mar-Apr;68(2):115-121. doi: 10.1016/j.bjan.2017.09.001. Epub 2017 Oct 16.