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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01973530
• Other study ID #: BHJRC_HK_TKR_Study_2014
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 25, 2013
• Last updated: September 8, 2014
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2014
• Source: Queen Elizabeth Hospital, Hong Kong
• Contact: Eric So, FHKCA FHKAM
• Phone: 29588888
• Email: sohke[@]ha.org.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• adductor canal block
Continuous adductor canal block and single shot posterior tibial nerve block under ultrasound guidance and using nerve stimulating needle (bolus: 0.5% Ropivacaine 10-15ml with dexamethasone 4mg ;with single shot posterior tibial nerve block (8-10ml 0.5% ropivacaine)
• femoral nerve block
Femoral nerve catheter inserted under ultrasound guidance using nerve stimulating needle administering ropivacaine bolus 10-15ml and infusing 0.2% ropivacaine at 4-6ml/h; plus a single shot posterior tibial nerve block under ultrasound guidance and use of nerve stimulating needle

Locations

Country	Name	City	State
Hong Kong	Joint Replacement Center, Buddhist Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCA morphine or pain rescuer consumption at 24h and 48h postoperative		24h and 48h postoperative	No
Primary	Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery		6h,12h, 24h,48h, 72h after surgery	No
Primary	Quadriceps strength at 24h, 48h, 72h postoperative	using dynamometer (measure in Newton/centimeter square)	24h, 48h, 72h postoperative	No
Secondary	Patient satisfaction score (0-4)		upon discharge	No
Secondary	Incidence of side effects and complications at postoperative day 0- 4 postoperative		postoperative period 0-96 hr postoperative	Yes
Secondary	Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay		upon discharge	No
Secondary	postoperative nausea or vomiting		0-72h	No
Secondary	postoperative pruritis		0-72h	No
Secondary	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	No