Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade

University of Chile

Status and phase: Completed; Phase 4

Conditions: Analgesia; Acute Pain; Upper Extremity Injury

Treatments: Drug: Bupivacaine Hydrochloride; Drug: Bupivacaine Hydrochloride with Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05359731

OAIC 1249/22

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Perineural Bupivacaine

Active Comparator group

Description:

Bupivacaine without Dexamethasone in axillary brachial plexus blockade

Treatment:

Drug: Bupivacaine Hydrochloride

Perineural Bupivacaine plus Dexamethasone

Experimental group

Description:

Bupivacaine with Dexamethasone in axillary brachial plexus blockade

Treatment:

Drug: Bupivacaine Hydrochloride with Dexamethasone