A comparison of post operative pain relief after surgery to the upper arm. An interscalene block involves an injection of local anaesthetic in the neck tothe nerves that supply the sensation to the arm. A stellate ganglion block involves ain injection of local anaesthetic in the neck to the sympathetic nerves to the arm.

• Conditions: We propose that an interscalene brachial plexus block combined with stellate ganglion block will give superior postoperative analgesia compared to interscalene brachial plexus block alone in major orthopaedic surgery of the upper limb.; MedDRA version: 14.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-003523-35-IE
• Lead Sponsor: Department of Anaesthesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adults 18-80 years
Major orthopaedic surgery of the upper limb.
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 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

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
Contralateral phrenic nerve palsy
Patients unable to withstand a 25% decrease in pulmonary function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We hypothesise that blockade of the stellate ganglion combined with the interscalene block will provide more effective analgesia in patients presenting for upper limb surgery compared with interscalene brachial plexus block alone .<br>Primary outcomes:<br>Severity of postoperative pain via visual analogue pain scale <br>Total opiate used in the first 48 hours after surgery<br>;Secondary Objective: Nausea or vomiting<br>Sedation<br>Itch<br>Duration of Horners syndrome<br>Duration of interscalene nerve block<br>Block complications<br>Patient satisfaction<br>Physiotherapy assessments<br>;Primary end point(s): Severity of postoperative pain via visual analogue pain scale <br>Total opiate used in the first 48 hours after surgery<br>;Timepoint(s) of evaluation of this end point: 48 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Nausea or vomiting<br>Sedation<br>Itch<br>Duration of Horners syndrome<br>Duration of interscalene nerve block<br>Block complications<br>Patient satisfaction<br>Physiotherapy assessments<br>;Timepoint(s) of evaluation of this end point: 48 hours