The effect of different doses of dexamethasone in the duration of analgesia when used as an adjuvant in brachial plexus blocks

The dose response of Dexamethasone as perineural adjuvant in Brachial Plexus Block. - DXMPN2017

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002815-32-BE

Enrollment

Registered

2017-07-20

Start date

2017-10-05

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: Solution for injection Pharmaceutical form of the placebo: Solution for solution for infusion Route of administration of the placebo: Perineural use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients presenting for elective arthroscopic shoulder surgery (incl. decompression and cuff repairs), aged 18-85 years willing to sign informed consent. 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 75 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Contraindications for brachial plexus blocks: coagulopathies, severe bronchopulmonary disease, intolerance to the study medication, pre-existing neuropathies, infection in the region of the interscalene groove. • Weight 30 • Impossibility to understand and sign the informed consent • Refusal of the patient

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the effect of different doses of perineural 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: 48 hours	—

Measure

Time frame

Main Objective: What is the effect of different doses of perineural 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: 48 hours

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Secondary

Measure	Time frame
Secondary end point(s): • Onset of sensory block: time from injection to complete sensory block • Onset of motor block: time from injection to complete motor block • Duration of motor block: time from injection to start of recovery of the motor block • Postoperative analgesic drug consumption • Pain scores at different endpoints (PACU admission, PACU discharge, Hospital discharge, 24 hours, 48 hours post block) expressed on a numeric rating scale (NRS 0-10, 0= no pain, 10= worst pain imaginable) • Incidence of postoperative nausea and vomiting • Incidence of pruritus • Patient satisfaction score expressed in a numeric rating scale (NRS 0-10, 0= totally dissatisfied, 10= complete satisfaction) • Incidence of hematoma formation at 48 hours • Incidence of infections at 48 hours and after 7 days • Incidence of neuropathic pain at 7 days and at 3 months postoperatively • Incidence of paresthesias at 7 days and at 3 months postoperatively • Incidence of muscle weakness at 7 days and at 3 months postoperatively ;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Secondary end point(s): • Onset of sensory block: time from injection to complete sensory block • Onset of motor block: time from injection to complete motor block • Duration of motor block: time from injection to start of recovery of the motor block • Postoperative analgesic drug consumption • Pain scores at different endpoints (PACU admission, PACU discharge, Hospital discharge, 24 hours, 48 hours post block) expressed on a numeric rating scale (NRS 0-10, 0= no pain, 10= worst pain imaginable) • Incidence of postoperative nausea and vomiting • Incidence of pruritus • Patient satisfaction score expressed in a numeric rating scale (NRS 0-10, 0= totally dissatisfied, 10= complete satisfaction) • Incidence of hematoma formation at 48 hours • Incidence of infections at 48 hours and after 7 days • Incidence of neuropathic pain at 7 days and at 3 months postoperatively • Incidence of paresthesias at 7 days and at 3 months postoperatively • Incidence of muscle weakness at 7 days and at 3 months postoperatively ;Timepoint(s) of evaluation of this end point: 48 hours

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Countries

Belgium

Contacts

Public ContactMatthias Desmet

AZ Groeninge

matthias.desmet@azgroeninge.be003256633050

Outcome results

None listed

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