CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Bupivacaine Hydrochloride +1 moredrug
Likely dose
Bupivacaine Hydrochloride 30 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05359731
NCT05359731Phase 4Completed

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

University of Chile·interventional·Posted May 4, 2022·Updated Oct 17, 2023

In Brief

A Phase 4 clinical trial evaluating Bupivacaine Hydrochloride and Bupivacaine Hydrochloride with Dexamethasone for Analgesia and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMay 4, 2022
Enrollment StartJun 28, 2022
Primary CompletionApr 17, 2023
Study CompletionApr 24, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.2 years ago

Interventions

Bupivacaine Hydrochloridedrug

Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.

Bupivacaine Hydrochloride with Dexamethasonedrug

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.