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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-prick

Difference 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

Page last updated: August 23, 2015

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