Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Ropivacaine + placebo; Drug: Ropivacaine + dexamethasone

• Registration Number: NCT02351804
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.

The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Study Start: 2015-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• American Society of Anesthesiologists class 1
• Body Mass Index 18-30

Exclusion Criteria

• Allergy to study medication
• Earlier trauma or surgery to lower limb
• Diabetes Mellitus
• Alcohol or drug abuse
• Daily intake of opioids or steroids last 4 weeks
• Daily intake of any analgesics last 48 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ropivacaine + placebo	Ropivacaine + placebo	20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad
Ropivacaine + dexamethasone	Ropivacaine + dexamethasone	20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml

Primary Outcome Measures

Name	Time	Method
Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab	0-36 hours	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.

Secondary Outcome Measures

Name	Time	Method
Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold	0-36 hours	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).; Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation	0-36 hours	Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.
Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick	0-36 hours	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).
Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test	0-36 hours	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except 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.
Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold	0-36 hours	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).; Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.

Trial Locations

Locations (1)

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark