A study investigating the effects on pain and morphine consumption - using 3 different administration modes of local anesthetic for an adductor canal block

Phase 1

Conditions: Primary total knee arthroplasty
MedDRA version: 19.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2016-005069-30-DK

Lead Sponsor: Pia Jæger

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 153

Inclusion Criteria

•Age > 18 years old
•Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia
•Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
•ASA 1-3
•Ability to perform a TUG test preoperatively

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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 83

Exclusion Criteria

•Patients who cannot cooperate
•Patients who cannot understand or speak Danish.
•Patients with allergy to the medicines used in the study
•Patients with a daily intake of strong opioids (morphine, oxycodone, ketobe-midone, methadone, fentanyl) during the last 4 weeks
•Patients suffering from alcohol and/or drug abuse – based on the investiga-tor's assessment
•Rheumatoid arthritis
•BMI > 40
•Neuromuscular pathology in the lower limbs
•Pregnancy
Pregnancy testing will be performed prior to inclusion in women of child bearing potential

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypoth-esis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard cath-eter. ;Secondary Objective: not applicable;Primary end point(s): •Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC), from end of surgery until 12 PM on POD 2.;Timepoint(s) of evaluation of this end point: From end of surgery until 12 PM on post-operative day 2

Secondary Outcome Measures