Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

Healthy Volunteers Clinical Trial

Official title:

Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351804
• Other study ID #: SM2-PJ-14
• Secondary ID: 2014-004879-23
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2015
• Last updated: August 31, 2015
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Ropivacaine + dexamethasone
Adductor canal block, single bolus
• Ropivacaine + placebo
Adductor canal block, single bolus

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital	Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab	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.	0-36 hours	No
Secondary	Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick	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).	0-36 hours	No
Secondary	Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test	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.	0-36 hours	No
Secondary	Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold	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.	0-36 hours	No
Secondary	Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold	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.	0-36 hours	No
Secondary	Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation	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.	0-36 hours	No