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Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone After a Single-injection Interscalene Nerve Block.

Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone Following a Single-injection Interscalene Nerve Block: A Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07324499
Enrollment
40
Registered
2026-01-07
Start date
2026-05-19
Completion date
2027-12-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bupivacaine, Dexamethasone, Interscalene Blocks, Pain

Keywords

Dexamethasone, Bupivacaine, Pain, Interscalene blocks

Brief summary

Recent studies have highlighted the comparative advantages of perineural dexamethasone, particularly regarding its safety profile and its ability to prolong analgesia in various peripheral nerve blocks. A recent systematic review demonstrated that perineural administration of dexamethasone significantly extends the duration of analgesia compared to intravenous administration. The mechanism of action of perineural dexamethasone remains unclear. Moreover, there is a lack of research comparing the systemic absorption of local anesthetics administered perineurally with or without dexamethasone, and the systemic absorption and bioavailability of dexamethasone when used as a perineural adjuvant have not been studied. Objective: This study aims to compare plasma concentrations of bupivacaine following a single-shot interscalene block with dexamethasone administered either perineurally or intravenously. Methodology: A prospective, randomized, double-blind trial will be conducted involving 40 patients undergoing shoulder surgery requiring a single-shot interscalene block. Each patient will receive 20 mL of 0.25% bupivacaine combined with 8 mg of dexamethasone administered either perineurally or intravenously. Venous blood samples (5 mL) will be collected at 5, 10, 20, 40, 80, 120, and 240 minutes post-block, and one sample at discharge, to measure plasma concentrations of both enantiomers of bupivacaine (D(+)-bupivacaine and L(-)-bupivacaine) and dexamethasone. Outcomes: The study will compare plasma levels of bupivacaine between groups, characterize the pharmacokinetics of bupivacaine and dexamethasone, and assess block duration and opioid consumption.

Interventions

DRUGadministration of dexamethasone intravenously

IV dexamethasone administration will be added to the interscalene block. In the control group, dexamethasone will be applied perineurally.

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

\- ASA I-II patients, with a body mass index (BMI) between 20 and 34 kg/m2 scheduled for shoulder surgery requiring single-needle interscalene block

Exclusion criteria

\- Chronic opioid use, liver failure, kidney failure, allergy to protocol drugs

Design outcomes

Primary

MeasureTime frameDescription
plasma levels of bupivacaine between groups4 hoursPlasma levels of bupivacaine after a single-shot interscalene block combined with dexamethasone administration ev or perineurally

Countries

Chile

Contacts

CONTACTAndrea Araneda, MD
andreaaraneda10@gmail.com56955043270
CONTACTRicardo Fuentes, MD
rsfuente@uc.cl56955043270

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026