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Clinical Trials/NCT07324499
NCT07324499RecruitingNot Applicable

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

Pontificia Universidad Catolica de Chile1 site in 1 country40 target enrollmentStarted: May 19, 2026Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
plasma levels of bupivacaine between groups

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Intravenous dexamethasone

Active Comparator

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Intervention: administration of dexamethasone intravenously (Drug)

Local dexamethasone

No Intervention

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Outcomes

Primary Outcomes

plasma levels of bupivacaine between groups

Time Frame: 4 hours

Plasma levels of bupivacaine after a single-shot interscalene block combined with dexamethasone administration ev or perineurally

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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