Comparison of different treatment modalities in peripheral nerve block catheter-based pain treatment after orthopaedic surgery.

Phase 1

• Conditions: Postoperative pain, after orthopaedic surgery.; MedDRA version: 20.0 Level: PT Classification code 10029173 Term: Nerve block System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-002280-18-DK
• Lead Sponsor: ordsjællands Hospital Hillerød

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

Substudy one:
1.=18 years of age
2.Scheduled for elective shoulder arthroplasty, rotator cuff repair, or Bankart operation
3.ASA classification24 = III
4.Agreement to the trial protocol

Substudy two:
1) Age = 18 years
2) American Society of Anesthesiologists Classification I-III
3) Normal cognitive function in order to sign written, informed consent
and to understand trial protocol
4) Agreement to the trial protocol, including the randomized manner

Substudy three:
1) Age = 18 years
2) American Society of Anesthesiologists Classification I-III
3) Normal cognitive function in order to sign written, informed consent
and to understand trial protocol
4) Agreement to the trial protocol, including the randomized manner
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Substudy one:
1.Body weight = 50 kg
2.Allergy to local anaesthetics
3.Mental or cognitive disease that impede compliance
4.Contraindication of interscalene brachial plexus nerve block (i.e. pneumothorax, severe pulmonary disease)
5.Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion.
6.Pregnancy or breastfeeding

Substudy two and three:
1) Allergy to LA
2) Infection in or near insertion site of the peripheral nerve catheter
3) Habitual use of opioids
4) Pregnancy or breastfeeding

Study & Design

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