Comparison of Femoral Nerve Catheter and Adductor Canal Block With Steroid Adjuvant in Total Knee Replacement (TKR)

Phase 4

• Conditions: Osteoarthritis

• Registration Number: NCT01973530
• Lead Sponsor: Queen Elizabeth Hospital, Hong Kong

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.

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-10-31
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09
• Study Start: 2014-10
• Primary Completion: 2015-02
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery	6h,12h, 24h,48h, 72h after surgery
PCA morphine or pain rescuer consumption at 24h and 48h postoperative	24h and 48h postoperative
Quadriceps strength at 24h, 48h, 72h postoperative	24h, 48h, 72h postoperative	using dynamometer (measure in Newton/centimeter square)

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects and complications at postoperative day 0- 4 postoperative	postoperative period 0-96 hr postoperative
Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients	on call and every 8 hours after surgery for postoperative 24h
Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay	upon discharge
postoperative nausea or vomiting	0-72h
postoperative pruritis	0-72h
Patient satisfaction score (0-4)	upon discharge

Trial Locations

Locations (1)

Joint Replacement Center, Buddhist Hospital; 🇭🇰 Kowloon, Hong Kong