Local anesthetic block of the suprascapular nerve after shoulder surgery - a randomized, blinded, placebo controlled trial.

Suprascapular nerve block as postoperative analgesia after artroscopic shoulder surgery - a randomized, blinded, placebo controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002391-24-DK

Enrollment

Registered

2015-06-12

Start date

2015-08-19

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

MedDRA version: 19.0 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: Patients planned for artroscopic shoulder surgery. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Patients with a VAS (Visual Analog Scale) never equal to or exceeding 5 during the first hour after arrival to the PACU (post anesthesia care unit).

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to examine the reduction in postoperative pain after arthroscopic shoulder surgery in patients treated with a suprascapular nerve block.;Secondary Objective: Not applicable;Primary end point(s): Change in VAS (Visual Analog Scale) at rest from TR (time of randomization) to T½ (30 minutes after injection of local anesthetic or placebo).;Timepoint(s) of evaluation of this end point: TR (time of randomization) T½ (30 minutes after injection of local anesthetic or placebo)	—

Measure

Time frame

Main Objective: The objective of this study is to examine the reduction in postoperative pain after arthroscopic shoulder surgery in patients treated with a suprascapular nerve block.;Secondary Objective: Not applicable;Primary end point(s): Change in VAS (Visual Analog Scale) at rest from TR (time of randomization) to T½ (30 minutes after injection of local anesthetic or placebo).;Timepoint(s) of evaluation of this end point: TR (time of randomization) T½ (30 minutes after injection of local anesthetic or placebo)

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Secondary

Measure	Time frame
Secondary end point(s): - Painscores (VAS) at maximum active abduction of the shoulder ½-6 hours after injection of local anesthetic or placebo described as area under the curve (AUC) - Painscores (VAS) at rest ½-6 hours after injection of local anesthetic or placebo described as area under the curve (AUC) - Total use of morphin measured in milligrams (mg) 6 hours after injection of local anesthetic og placebo. - Change in activity of the infraspinatus muscle from TR to T½ measured with surface electromyography (sEMG). - Change in strength of the infraspinatus muscle (external rotation of the shoulder) and the supraspinatus and deltoid muscles (abduction of the shoulder) from TR to T½ measured with a handheld dynamometer.;Timepoint(s) of evaluation of this end point: T½, T1, T2, T3, T4, T5, T6 (½-6 hours after injection of either local anesthetic or placebo)	—

Measure

Time frame

Secondary end point(s): - Painscores (VAS) at maximum active abduction of the shoulder ½-6 hours after injection of local anesthetic or placebo described as area under the curve (AUC) - Painscores (VAS) at rest ½-6 hours after injection of local anesthetic or placebo described as area under the curve (AUC) - Total use of morphin measured in milligrams (mg) 6 hours after injection of local anesthetic og placebo. - Change in activity of the infraspinatus muscle from TR to T½ measured with surface electromyography (sEMG). - Change in strength of the infraspinatus muscle (external rotation of the shoulder) and the supraspinatus and deltoid muscles (abduction of the shoulder) from TR to T½ measured with a handheld dynamometer.;Timepoint(s) of evaluation of this end point: T½, T1, T2, T3, T4, T5, T6 (½-6 hours after injection of either local anesthetic or placebo)

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Countries

Denmark

Contacts

Public ContactDepartment of anesthesiology

Nordsjaellands Hospital

christian@steen-hansen.dk

Outcome results

None listed

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