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

NCT07324499 | Not Yet Recruiting DMC

• 1 other identifier: 250429018
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Interscalene Blocks; Dexamethasone; Bupivacaine

Keywords

Dexamethasone; Bupivacaine; Pain; Interscalene blocks

Outcome Measures

Primary Outcomes (1)

• plasma levels of bupivacaine between groups

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

  4 hours

Study Arms (2)

Intravenous dexamethasone

ACTIVE COMPARATOR

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Drug: administration of dexamethasone intravenously

Local dexamethasone

NO INTERVENTION

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Interventions

administration of dexamethasone intravenously DRUG

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

Intravenous dexamethasone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 7, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-09