Knee Arthropathy, Postoperative Pain, Postoperative Complications
Conditions
Keywords
ERAS, pain, knee arthroplasty, joint pain, regional anaesthesia
Brief summary
Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
Detailed description
Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
Interventions
PROCEDURElocal infiltration analgesia
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
PROCEDUREregional-anaesthesiological catheter analgesia
Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either regional-anaesthesiological catheters preoperatively or are treatet with local infiltration technique perioperatively. For the purpose of this trial is would not be feasable to perform sham regional-anaesthesiological procedures and blinding of the treating physisican will not be possible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing elective, primary knee joint replacement in combined general anaesthesia
Exclusion criteria
* heart insufficiency NYHA \>2 * liver insufficiency \> CHILD B * evidence of diabetic polyneuropathy * severe adipositas BMI \>40 * patients \< 18 years * pregnancy * in case of police custody * participation in a paralleled interventional RCT in a time frame of 30 days * chronic opioid therapy \>3 months before scheduled surgery * allergy against medication required for surgery or anaesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to first mobilisation (standing) | up to 48h postoperatively | time from end of surgery until patients is able to stand |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to first mobilisation (walking) | up to 7 days postoperatively | time from end of surgery until patients is able to walk |
| complications | up to 7 days postoperatively | complications during perioperative care process (e.g. thrombosis, re-operation, infection) |
| time to achieve full joint mobility | up to 7 days postoperatively | time to achieve full joint mobility (0/0/90°) |
| patients satisfaction (11-point likert scale) | up to 7 days postoperatively | global satisfaction of patients |
| rescue pain medication | up to 7 days postoperatively | number of patients requiring rescue pain medication |
| pain medication perioperatively | up to 7 days postoperatively | pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics) |
| time to discharge | up to 14 days postoperatively | time to discharge from hospital |
| pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean) | up to 7 days postoperatively | mean pain intensity of patients |
Countries
Germany
Outcome results
None listed