PainNCT07324499
Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone After a Single-injection Interscalene Nerve Block.
A study testing administration of dexamethasone intravenously in people with Pain and Interscalene Blocks, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Interscalene Blocks, Dexamethasone
- What is being tested?
- administration of dexamethasone intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 19 May 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic opioid use, liver failure, kidney failure, allergy to protocol drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Red Salud UCChristus
Santiago
Victor Contreras, MSN, 56981895232, vecontre@uc.cl
About this study
Official title: Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone Following a Single-injection Interscalene Nerve Block: A Randomized Controlled Study
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.
Read more
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
- Being tested
- administration of dexamethasone intravenously
- Keywords
- Dexamethasone, Bupivacaine, Pain, Interscalene blocks
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of dexamethasone intravenouslyDrug
IV dexamethasone administration will be added to the interscalene block. In the control group, dexamethasone will be applied perineurally.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dexamethasone | Active comparator | cccc Receives: Drug: administration of dexamethasone intravenously |
| Local dexamethasone | No intervention | ccc |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma levels of bupivacaine between groups
Plasma levels of bupivacaine after a single-shot interscalene block combined with dexamethasone administration ev or perineurally
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start19 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324499
- Sponsor's protocol ID
- 250429018
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Plasma Levels of Bupivacaine and Dexamethasone Following a Single-injection Interscalene Nerve Block: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07324499
- Acronym / sponsor ID
- 250429018
- Conditions
- Pain, Interscalene Blocks, Dexamethasone, Bupivacaine
- Keywords
- Dexamethasone, Bupivacaine, Pain, Interscalene blocks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexamethasone | Active comparator | Drug: administration of dexamethasone intravenouslycccc |
| Local dexamethasone | No intervention | –ccc |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic opioid use, liver failure, kidney failure, allergy to protocol drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration of dexamethasone intravenouslyIV dexamethasone administration will be added to the interscalene block. In the control group, dexamethasone will be applied perineurally. | Drug | Intravenous dexamethasone |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of dexamethasone intravenously in people with Pain and Interscalene Blocks, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Araneda, MD (56955043270, andreaaraneda10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma levels of bupivacaine between groups (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.