The use of a supraclavicular nerve catheter for local anesthetic block of the shoulder - an explorative study in healthy volunteers.

Supraclavicular catheter for regional anesthesia of the shoulder - an explorative study in healthy volunteers.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002835-14-DK

Enrollment

Unknown

Registered

2016-08-17

Start date

2016-10-07

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

MedDRA version: 19.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Ropivacain Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacain Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers aged 18 or above 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: - Congenital or acquired sensory, motor or other neurologic damage to shoulder or upper extremity. - BMI above 30 - Allergy to ropivacain - Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trial is to place a supraclavicular catheter in 32 healthy volunteers and examine: 1: If the largest shoulder nerves are affected 2: which other nerves are affected after injection with a low (5ml) or a high (20 ml) volume of ropivacain 5 mg/ml.;Secondary Objective: Not applicable;Primary end point(s): Succesfull shoulder block (yes/no) defined as sensory affection of the axillary nerve combined with motor affection of the suprascapular nerve.;Timepoint(s) of evaluation of this end point: TB: Baseline measurement after placement of nerve catheter. T1: 45 minutes after injection of ropivacain.	—

Measure

Time frame

Main Objective: The objective of the trial is to place a supraclavicular catheter in 32 healthy volunteers and examine: 1: If the largest shoulder nerves are affected 2: which other nerves are affected after injection with a low (5ml) or a high (20 ml) volume of ropivacain 5 mg/ml.;Secondary Objective: Not applicable;Primary end point(s): Succesfull shoulder block (yes/no) defined as sensory affection of the axillary nerve combined with motor affection of the suprascapular nerve.;Timepoint(s) of evaluation of this end point: TB: Baseline measurement after placement of nerve catheter. T1: 45 minutes after injection of ropivacain.

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Secondary

Measure	Time frame
Secondary end point(s): - Change in lung function (PEF(Peak Expiratoric Flow Rate in l/min), FEV1(Forced Expiratory Volume in first second in litres), FVC(Forced Vital Capacity in litres) og VC (Vital Capacity in litres)) measured with a spirometer at TB and T1. - Horners syndrom present (yes/no). - Hoarseness present (yes/no) - Sensory affection (yes/no) of the following nerves: axillary nerve, musculocutaneus nerve, radial nerve, median nerve, ulnar nerve. - Motor affection (yes/no) of the following nerves: suprascapular nerve, axillary nerve, musculocutaneus nerve, radial nerve, median nerve, ulnar nerve. - Displacement of catheter after physical exercise (yes/no). - Duration of anesthesia (hours). - Change in muscle strengt (lbs) measured with a handheld dynamometer at TB and T1 during maximum voluntary contraction of the following muscles: infraspinatus muscle, deltoid muscle. - Subjectiv feeling of dyspnea (yes/no);Timepoint(s) of evaluation of this end point: TB: Baseline measurement after placement of nerve catheter. T1: 45 minutes after injection of ropivacain. T2: Immediately after physical exercise. T3: Telephone interview 24 hours after T1.	—

Measure

Time frame

Secondary end point(s): - Change in lung function (PEF(Peak Expiratoric Flow Rate in l/min), FEV1(Forced Expiratory Volume in first second in litres), FVC(Forced Vital Capacity in litres) og VC (Vital Capacity in litres)) measured with a spirometer at TB and T1. - Horners syndrom present (yes/no). - Hoarseness present (yes/no) - Sensory affection (yes/no) of the following nerves: axillary nerve, musculocutaneus nerve, radial nerve, median nerve, ulnar nerve. - Motor affection (yes/no) of the following nerves: suprascapular nerve, axillary nerve, musculocutaneus nerve, radial nerve, median nerve, ulnar nerve. - Displacement of catheter after physical exercise (yes/no). - Duration of anesthesia (hours). - Change in muscle strengt (lbs) measured with a handheld dynamometer at TB and T1 during maximum voluntary contraction of the following muscles: infraspinatus muscle, deltoid muscle. - Subjectiv feeling of dyspnea (yes/no);Timepoint(s) of evaluation of this end point: TB: Baseline measurement after placement of nerve catheter. T1: 45 minutes after injection of ropivacain. T2: Immediately after physical exercise. T3: Telephone interview 24 hours after T1.

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Countries

Denmark

Contacts

Public ContactDepartment of anesthesiology

Nordsjællands Hospital Hillerød

christian@steen-hansen.dk

Outcome results

None listed

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