Postoperative Pain Clinical Trial
— ADEXAOfficial title:
Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial
Verified date | October 2017 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block
Status | Completed |
Enrollment | 99 |
Est. completion date | September 16, 2017 |
Est. primary completion date | March 16, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ASA 1,2 et 3 - surgery under axillary brachial plexus block - aged >18 years - signed information consent Exclusion Criteria: - impaired coagulation - contraindication to regional anesthesia or technical impossibility - opioids or pain killers abuse or addiction - steroids consumption in the past 6 months - dementia or under administrative supervision - delay of surgery to short to allow regional anesthesia - pregnancy and breastfeeding - allergy and contraindication to dexamethasone or ropivacaine - anticipated bad observation of treatment - patient enrolled in another trial |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Besancon | Besancon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analgesia duration after axillary brachial plexus block | time to first pain at surgical site, an average of 24 hours | ||
Secondary | Motor block duration after axillary brachial plexus block Safety | up to block recovery, an average of 24 hours | ||
Secondary | Sensory block duration after axillary brachial plexus block | up to block recovery, an average of 24 hours | ||
Secondary | incidence of adverse event | 6 month |
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