Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Ropivacaine + dexamethasone (Drug); Ropivacaine + placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s): Pia Jæger, MD, PhD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
Overall contact: Pia Jæger, MD, PhD, Phone: 0045 3545 3478, Email: pia.therese.jaeger@regionh.dk
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab
Secondary outcome: Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prickDifference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Pia Jæger, MD, PhD, Phone: 0045 3545 3478, Email: pia.therese.jaeger@regionh.dk
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital, Gentofte, Hellerup 2900, Denmark; Recruiting Ulrik Grevstad, MD, Phone: 0045 3977 3892, Email: ulrik.grevstad@hotmail.com Bo Gottschau, MD, Phone: 0045 3977 5263, Email: bogo@geh.regionh.dk Ulrik Grevstad, MD, Principal Investigator
Additional Information
Starting date: February 2015
Last updated: March 2, 2015
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