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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.

A comparison of interscalene brachial plexus block combined with stellate ganglion block versus interscalene brachial plexus block for postoperative analgesia in major orthopaedic surgery of the upper limb.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-003523-35-IE
Enrollment
74
Registered
2011-08-05
Start date
2011-10-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: naropin Product Name: ropivacaine Product Code: N01BB09 Pharmaceutical Form: Solution for injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml millig

Sponsors

Department of Anaesthesia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 . Primary outcomes: Severity of postoperative pain via visual analogue pain scale Total opiate used in the first 48 hours after surgery ;Secondary Objective: Nausea or vomiting Sedation Itch Duration of Horners syndrome Duration of interscalene nerve block Block complications Patient satisfaction Physiotherapy assessments ;Primary end point(s): Severity of postoperative pain via visual analogue pain scale Total opiate used in the first 48 hours after surgery ;Timepoint(s) of evaluation of this end point: 48 hours

Secondary

MeasureTime frame
Secondary end point(s): Nausea or vomiting Sedation Itch Duration of Horners syndrome Duration of interscalene nerve block Block complications Patient satisfaction Physiotherapy assessments ;Timepoint(s) of evaluation of this end point: 48 hours

Countries

Ireland

Contacts

Public ContactJohn McDonnell

Department of Anaesthesia

johngmcdonnell@gmail.com+35391544074

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026