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A study of the effect of different doses of dexamethasone on the duration of an single shot interscalene block for shoulder surgery.

The effect of low dose intravenous dexamethasone on the analgesic duration of single shot interscalene block with ropivacaine for shoulder surgery. A prospective, double blind, randomized, placebo controlled trial. (LDD trial, Low dose dexamethasone trial) - LDD Trial (Low Dose Dexamethasone Trial)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005565-12-BE
Enrollment
240
Registered
2013-01-07
Start date
2013-02-18
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Postoperative pain

Interventions

Trade Name: Aacidexam Pharmaceutical Form: Concentrate for solution for injection/infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous

Sponsors

AZ Groeninge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients >18 years for arthroscopic shoulder surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Exclusion criteria are: age <18 years, brachial plexus neuropathies, severe bronchopulmonary disease, coagulopathies, systemic glucocorticoid use, pregnancy, intolerance to the study medication and diabetes.

Design outcomes

Secondary

MeasureTime frame
Secondary end point(s): pains scores analgesic use motor block scores sleep disturbance patient satisfaction;Timepoint(s) of evaluation of this end point: 48 hours

Primary

MeasureTime frame
Main Objective: What is the effect of different doses of intravenous dexamethasone on postoperative analgesia after interscalene plexus block for shoulder surgery.;Secondary Objective: What is the effect of different doses of dexamethasone on postoperative painscores, analgesic use, patient satisfaction, duration and quality of motor block and sleep disturbance.;Primary end point(s): time to first analgesic request;Timepoint(s) of evaluation of this end point: 48h

Countries

Belgium

Contacts

Public ContactMAtthias Desmet

AZ Groeninge

matthias.Desmet@azgroeninge.be00325656633050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026