The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijnbestrijding bij primaire totale knieprothese
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
functional outcome after total knee arthroplasty measured with a performance
battery consisting of three functional tasks: Timed-Up-And-Go test, Stair Climb
Task en Six Minutes Walk Test. These tests are done: . pre-operatively, 2. when
reaching discharge criteria, 3. three months post-operatively, 4. one year
post-operatively
Secondary outcome
length of stay, time to reach discharge criteria, quantity and quality of
mobilization during hospital stay, pain medication consumption postoperatively
(during hospital stay and after hospital discharge), painscores at rest and
during mobilization, patient satisfaction with analgesia and the fast track
protocol, range of motion of the operated knee, functional outcome of the knee
reported by the patient, fear of motion and quality of life.
Background summary
For an optimal and fast recovery after total knee arthroplasty (TKA), a fast
track rehabilitation protocol has been developed. The literature is not yet
conclusive about the optimal anesthetic technique for this protocol. The
optimal technique should support fast mobilization, by giving good pain
relieve, with minmal side effects such as nausea, drowsiness and muscle
weekness. Is pain relieve is optimal, the patient molizes fast and lenth of
stay is shortened. But does fast recovery lead to better functional outcome?
Study objective
The objective of this study is to determine whether either a femoral nerve
block (FNB) or local infiltration analgesia (LIA) is a better anesthetic
technique to achieve optimal functional outcome after one year in patients
receiving a total knee arthroplasty and following a fast track rehabilitation
protocol.
Study design
The study is designed as a prospective mono-centre observer blinded randomized
controlled trial.
Intervention
Patients will receive a total knee replacement under spinal anesthesia and
posterior capsule infiltration combined with either a femoral nerve block (FNB)
or local infiltration analgesia (LIA).
Study burden and risks
Patients participating in this study will not be subjected to any additional
risk other than the common risks for surgery of primary knee arthroplasty or
the standard used anesthetic techniques. The will not be admitted earlier or
longer to the hospital.
The patient will visit the hospital one extra time pre-operatively for baseline
measures. During this visit there will be extensive time for extra explanation
of the study. This will be better than doing the functional tests on the day of
the operation (for ethical, safety and logistical reasons). Patients will
receive an travel and parking costs reimbursement.
Furthermore the patients will visit the clinic at regular follow-up moments.
Patients will do the functional tests when in the clinic for regular follow-up.
The questionnaires and physical examinations of the knee will take 15 minutes
together. The functional battery will take 30 minutes in total for each visit.
Participating in this research will take some extra time and effort from the
patient but brings very little extra burden.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
• age 50-80 years
• ASA physical health classification I - II
• patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
• patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
• scheduled for fast-track protocol TKA
• patient plans to be available for follow-up through one year postoperative
• written informed consent
Exclusion criteria
• any contra-indication for regional anesthesia
• any contra-indication for spinal anesthesia
• traumatic osteoarthritis requiring TKA
• an active, local infection or systemic infection
• known hypersensitivity to amide-type local anesthetics
• known hypersensitivity to opioids
• a Body Mass Index (BMI) > 40 kg/m2
• inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
• scheduled for contralateral TKA within 1 year post-operative
• scheduled for another operation within 3 months post-operative
• physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
• chronic opioid analgesic therapy
• rheumatoid arthritis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-001008-13-NL |
| CCMO | NL43965.072.13 |