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

Phase 1

• Conditions: MedDRA version: 19.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002391-24-DK
• Lead Sponsor: ordsjaellands Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-12
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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)<br>T½ (30 minutes after injection of local anesthetic or placebo)

Secondary Outcome Measures

Name	Time	Method
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)<br><br>- Painscores (VAS) at rest ½-6 hours after injection of local anesthetic or placebo described as area under the curve (AUC)<br><br>- Total use of morphin measured in milligrams (mg) 6 hours after injection of local anesthetic og placebo.<br><br>- Change in activity of the infraspinatus muscle from TR to T½ measured with surface electromyography (sEMG).<br><br>- 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)