A study investigating the effect on pain and morphine consumption of different pumpsettings for providing local anesthetics for a nerve block.

Phase 1

Conditions: Primary total knee arthroplasty
MedDRA version: 17.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2014-005642-22-DK

Lead Sponsor: Pia Jæger

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age > 18 years old
•Patients scheduled for total knee arthroplasty in spinal anesthesia
•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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

•Patients with allergy to the medicines used in the study
•Daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
•Rheumatoid arthritis
•BMI > 40
•Neuromuscular pathology in the lower limbs

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 analgesic effect of administering ropivacaine for an adductor canal block as re-peated intermittent boluses compared with a continuous infusion. ;Secondary Objective: Not applicable;Primary end point(s): Difference in total opioid consumption (PCA pump and any potential rescue or non-protocolled administration) between groups, from end of surgery until 12 PM on POD 2 .;Timepoint(s) of evaluation of this end point: Cummulative opioid consumption from end of surgery until 12 PM on POD 2, assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •VAS pain scores (0–100 mm) during 45 degrees active knee flexion analyzed using a line-ar mixed model <br>•VAS pain scores (0–100 mm) at rest analyzed using a linear mixed model <br>•Worst pain (VAS, 0–100 mm) during the TUG test <br>•Quadriceps strength assessed as MVIC in percentage of preoperative baseline values <br>•Time (seconds) to perform the Timed up and Go (TUG) test <br>•Number of patients able to perform the TUG test, using crutches<br>•6 min walk test performed using crutches <br>;Timepoint(s) of evaluation of this end point: VAS pain scores at rest and during knee flexion will be assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2.<br><br>Worst pain during the TUG test, the TUG test, quadriceps strength and the 6 min walk test will be assesseed at 12 PM on POD 1 and 2.