Does adding dexamethason to a local anesathetic prolong duration of nerve block?

Does perineural dexamethason prolong duration of an adductor canal block when controlling for a systemic effect? A randomized, blinded, crossover study in healthy volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004879-23-DK

Enrollment

Unknown

Registered

2014-11-25

Start date

2015-01-09

Completion date

Unknown

Last updated

2016-08-16

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

Conditions

Healthy volunteers (intended for postoperative pain treatment in patients after knee surgery) MedDRA version: 17.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Dexamethason KrKa Product Name: Dexamethason Krka Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone CAS Number: 312-93-6 Other descriptive name: DEXAMETHASONE

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Age 18-30 years Men ASA 1 BMI 18-30 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy to study medication Earlier trauma or surgery to lower limb Diabetes Mellitus

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether dexamethason as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect. ;Secondary Objective: To investigate dexamethasons effect on maximum pain scores during a tonic heat stimulation test and the potential effect on rebound pain.;Primary end point(s): Difference in duration of sensory block between dexamethason and placebo assessed as cold sensation with an alcohol swab.;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed).	—

Measure

Time frame

Main Objective: To investigate whether dexamethason as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect. ;Secondary Objective: To investigate dexamethasons effect on maximum pain scores during a tonic heat stimulation test and the potential effect on rebound pain.;Primary end point(s): Difference in duration of sensory block between dexamethason and placebo assessed as cold sensation with an alcohol swab.;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed).

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Secondary

Measure	Time frame
Secondary end point(s): Diffference between dexamethason and placebo in the duration of a sensory block assessed by: - pin-prick - maximum pain during tonic heat stimulation test - warmth detection thereshold - heat pain detection threshold Diffference in maximum pain scores between dexamethason and placebo during block and after recovery of normal sensation. ;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except warmth- and heat pain detection thresholds, which are only assessed if pain scores during tonic heat stimulation is above 0 and at 2 and 3 hours post block where there will be a break and no assessments will be performed). Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value for the tonic heat stimulation test, and detection thresholds of ± 2 degrees C of the pre-block value for the warmth detection thereshold and the heat pain detection threshold. Diffference in maximum pain scores will be assessed at 4 h post block and 1 h after pain scores have returned to the pre-block values.	—

Measure

Time frame

Secondary end point(s): Diffference between dexamethason and placebo in the duration of a sensory block assessed by: - pin-prick - maximum pain during tonic heat stimulation test - warmth detection thereshold - heat pain detection threshold Diffference in maximum pain scores between dexamethason and placebo during block and after recovery of normal sensation. ;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except warmth- and heat pain detection thresholds, which are only assessed if pain scores during tonic heat stimulation is above 0 and at 2 and 3 hours post block where there will be a break and no assessments will be performed). Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value for the tonic heat stimulation test, and detection thresholds of ± 2 degrees C of the pre-block value for the warmth detection thereshold and the heat pain detection threshold. Diffference in maximum pain scores will be assessed at 4 h post block and 1 h after pain scores have returned to the pre-block values.

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Countries

Denmark

Contacts

Public ContactClinical trials information

Rigshospitalet, Department of Anaesthesia

pia.therese.jaeger@regionh.dk00453545 3478

Outcome results

None listed

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