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Does the stellate ganglion block improve postoperative analgesia following upper limb trauma?

Conditions
We propose that the sympathetic nervous system contributes to acute pain and that a sympathetic nerve block, the stellate ganglion block, will improve postoperative pain in patients presenting for surgery for upper limb trauma.
MedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Registration Number
EUCTR2009-010708-28-IE
Lead Sponsor
Department of Anaesthesia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Adults 18-80 years
Traumatic upper limb surgery involving forearm fracture requiring internal fixation
ASA 1 to 3
Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient refusal
Local infection at the site of injection
Allergy to amide local anaesthetics, fentanyl, propofol, volatile anaesthetics, morphine, diclofenac or paracetamol
Concurrent use of MAOIs, or use within 2 weeks of anaesthesia
Recent myocardial infarct
Glaucoma
Pathological bradycardia
Sepsis
Anatomic abnormalities of the neck and upper limb
Difficult airway
Systemic anticoagulation or coagulopathy
Severe liver or cardiac disease
Inability to comprehend or participate in pain scoring system
Inability to use intravenous patient controlled analgesia

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Objective: Secondary measures: Nausea or vomiting<br>Sedation<br>Itch<br>Duration of Horners syndrome or other nerve block<br>Block complications<br>Patient satisfaction<br>;Main Objective: We hypothesise that blockade of the stellate ganglion will provide effective analgesia in patients presenting for upper limb surgery compared to placebo block and propose to test this hypothesis in a randomized, controlled, double blinded, clinical trial.<br>Primary Measures: Severity of postoperative pain via visual analogue pain scale <br>Total opiate used in the first 48 hours after surgery<br>;Primary end point(s): THe primary endpoint is postoperative pain, assessed via the Visual Analogue Scale, score.
Secondary Outcome Measures
NameTimeMethod
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