Ropivacain 0,2% plus Dexamethason versus Ropivacain 0,2% plus Placebo in modified pectoral block - A randomized, double-blind, prospective trial

Phase 1

• Conditions: women scheduled for elective breast surgery; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2018-003001-26-AT
• Lead Sponsor: Medizinische Universität Innsbruck, Universitätsklinik für Anästhesie und Allgemeine Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-07
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

°female
°ASA 1-2
°age 18-80 years
°BMI 18-35
°informed consent
°elective unilateral breast 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

°bleeding disorders
°known allergy to the administered drugs
°diabetes
°any disease that leads to an alteration in corticosteroid physiology
°drug abuse (esp. Opioids)
°systemic inflammation
°psychiatric disorders that lead to an alteration in perception and evaluation of pain
°tumor spread in the area of injection
°Inflammation in the area of injection
°pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to find out if dexamethason added to modified pectoral block (Pecs II) with ropivacain 0,2% prolongs analgetic effect;Secondary Objective: time to first opioid administration, VAS-score;Primary end point(s): total opioid consumption in the first 72h;Timepoint(s) of evaluation of this end point: after 72 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): time to first opioid administration, VAS-score (after 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours);Timepoint(s) of evaluation of this end point: time to first opioid administration, VAS-score (after 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours)