Primary total knee arthroplasty MedDRA version: 19.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Ropivacaine
Product Name: ropivacaine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Pia Jæger
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Pain 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. Ambulation and muscle strength will be assessed at 12PM on POD 1 and POD 2;Secondary end point(s): • VAS pain scores (0–100 mm) during 45 degrees active knee flexion analyzed using a linear mixed model with the inclusion of all time points. • VAS pain scores (0–100 mm) at rest analyzed using a linear mixed model with the inclusion of all time points. • Worst pain (VAS, 0–100 mm) during the TUG test on POD 1 and 2. • Quadriceps strength assessed as MVIC in percentage of preoperative baseline values on POD 1 and 2. • Time (seconds) to perform the TUG test on POD 1 and 2. • Number of patients able to perform the TUG test, using a high 4-wheel walker, on POD 1 and 2. • 6 min walk test performed on POD 1 and 2, using a high 4-wheel walker. As for the primary outcome, the secondary outcomes are also comparisons between the three groups: SB vs CC, SB vs SC and CC vs SC. | — |
Countries
Denmark
Contacts
Public ContactDepartment of anesthesia
Gentofte Hospital
Outcome results
None listed