Clinical trial NCT01973530: Comparison of Femoral Nerve Catheter and Adductor Canal Block With Steroid Adjuvant in Total Knee Replacement (TKR)
Official title: Comparison of the Analgesic Efficacy of Continuous Femoral Nerve Block and Adductor Canal Block With Steroid Adjuvant in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: femoral nerve block
adductor canal block
steroid
total knee replacement
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior analgesics and rehabilitation ability than continuous femoral nerve block for postoperative patients receiving total knee arthroplasty.

Detailed description: A total of 80 patients who will undergo total knee arthroplasty will be randomized into two groups:

Treatment groups Treatment details Femoral Group (40 patients) Continuous femoral nerve block (bolus: 0.5% Ropivacaine 10-15 ml ; infusion of 0.15 % Ropivacaine 4-6ml/h) Adductor Group (40 patients) Adductor canal block with steroid adjuvant (bolus: 0.5% Ropivacaine 10-15ml; Dexamethasone 4mg) (Total 80 patients will be recruited)

* All patients will receive single shot tibial nerve block with local anaesthetics (0.5% Ropivacaine 5-8ml) before surgery for analgesia of posterior knee.
* All patients will receive the same preemptive and postoperative multimodal medications for perioperative analgesia.
* All groups will receive standardized method of spinal anaesthesia and standardized method of intraoperative sedation for the surgery.
* Intravenous patient controlled analgesia (PCA) with morphine will be given for 48h to patient as rescue analgesia.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary osteoarthritis
* Scheduled for elective total knee arthroplasty
* Signed written informed consent
* Planned use of spinal anaesthesia
* Cognitive sound to use assessment tools

Exclusion Criteria:

* Patients refusing to give consents
* Scheduled for revision total knee replacement
* Patient outside range of 30 to 80 yrs old
* Non-chinese population
* Cognitive impairment/ inability to use the outcome assessment tools
* Contraindications to regional anesthesia
* severe cardiovascular disease (unstable angina, second or third degree heart block)
* pre-existing neurologic disease including psychiatric disorder
* drug abuser
* Pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
* Allergy or contraindication to drugs used in this study: morphine, Non-steroidal anti-inflammatory drugs (NSAID) such as ketorolac , diclofenac, dihydrocodeine, local anaesthetics (lignocaine, ropivacaine, bupivacaine), epinephrine
* Moderate or severe renal impairment (serum creatinine \> 160 micromol/l)

Primary outcomes:
measure: PCA morphine or pain rescuer consumption at 24h and 48h postoperative
timeFrame: 24h and 48h postoperative
measure: Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery
timeFrame: 6h,12h, 24h,48h, 72h after surgery
measure: Quadriceps strength at 24h, 48h, 72h postoperative
timeFrame: 24h, 48h, 72h postoperative
Secondary outcomes:
measure: Patient satisfaction score (0-4)
timeFrame: upon discharge
measure: Incidence of side effects and complications at postoperative day 0- 4 postoperative
timeFrame: postoperative period 0-96 hr postoperative
measure: Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay
timeFrame: upon discharge
measure: postoperative nausea or vomiting
timeFrame: 0-72h
measure: postoperative pruritis
timeFrame: 0-72h
measure: Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients
timeFrame: on call and every 8 hours after surgery for postoperative 24h
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Joint Replacement Center, Buddhist Hospital
Study officials:
affiliation: Queen Elizabeth Hospital, Hospital Authority
name: Eric So, FHKCA FHKAM
role: PRINCIPAL_INVESTIGATOR
References: