Quality of pain management with a nerve block applied for muscle sparing total hip arthroplasty

Phase 1

• Conditions: Total hip arthroplasty through minimal invasive muscle sparing surgery technique; MedDRA version: 20.0Level: PTClassification code 10020096Term: Hip arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003695-31-BE
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

?Male or female, at least 18 years of age at screening.
?Scheduled to undergo unilateral DAA THA
?American Society of Anesthesiologists (ASA) physical status 1, 2 or 3
?Able to demonstrate sensory function by exhibiting sensitivity to light touch
?Able to ambulate
?Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

?Previous open hip surgery
?History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
Contraindication to bupivacaine or morphine

Study & Design

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