NCT05359731

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

Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Analgesia
• Acute Pain
• Upper Extremity Injury

Interventions

Type	Name	Description
DRUG	Bupivacaine Hydrochloride	Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.
DRUG	Bupivacaine Hydrochloride with Dexamethasone	Patients will receive a total volume of 30 ml of bupivacaine 0.5% with Dexamethasone 4 mg in an axillary block with a double puncture.

Timeline

• Start date: 2022-06-28
• Primary completion: 2023-04-17
• Completion: 2023-04-24
• First posted: 2022-05-04
• Last updated: 2023-10-17

Locations

1 site across 1 country: Chile