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

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Phase 4

Locations

Hong Kong

Study Type

Interventional

Intervention

adductor canal block

femoral nerve block

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring femoral nerve block, adductor canal block, steroid, total knee replacement

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Joint Replacement Center, Buddhist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

adductor canal block

continuous femoral nerve block

Arm Description

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 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

Outcomes

Primary Outcome Measures

PCA morphine or pain rescuer consumption at 24h and 48h postoperative

Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery

Quadriceps strength at 24h, 48h, 72h postoperative

using dynamometer (measure in Newton/centimeter square)

Secondary Outcome Measures

Patient satisfaction score (0-4)

Incidence of side effects and complications at postoperative day 0- 4 postoperative

Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay

postoperative nausea or vomiting

postoperative pruritis

Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients

Full Information

NCT ID

NCT01973530

First Posted

October 25, 2013

Last Updated

September 8, 2014

Sponsor

Queen Elizabeth Hospital, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01973530

Brief Title

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

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen Elizabeth Hospital, Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

femoral nerve block, adductor canal block, steroid, total knee replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

adductor canal block

Arm Type

Active Comparator

Arm Description

Arm Title

continuous femoral nerve block

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

adductor canal block

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

femoral nerve block

Intervention Description

Primary Outcome Measure Information:

Title

PCA morphine or pain rescuer consumption at 24h and 48h postoperative

Time Frame

24h and 48h postoperative

Title

Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery

Time Frame

6h,12h, 24h,48h, 72h after surgery

Title

Quadriceps strength at 24h, 48h, 72h postoperative

Description

using dynamometer (measure in Newton/centimeter square)

Time Frame

24h, 48h, 72h postoperative

Secondary Outcome Measure Information:

Title

Patient satisfaction score (0-4)

Time Frame

upon discharge

Title

Incidence of side effects and complications at postoperative day 0- 4 postoperative

Time Frame

postoperative period 0-96 hr postoperative

Title

Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay

Time Frame

upon discharge

Title

postoperative nausea or vomiting

Time Frame

0-72h

Title

postoperative pruritis

Time Frame

0-72h

Title

Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients

Time Frame

on call and every 8 hours after surgery for postoperative 24h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric So, FHKCA FHKAM

Phone

29588888

sohke@ha.org.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric So, FHKCA FHKAM

Organizational Affiliation

Queen Elizabeth Hospital, Hospital Authority

Official's Role

Principal Investigator

Facility Information:

Facility Name

Joint Replacement Center, Buddhist Hospital

City

Kowloon

Country

Hong Kong

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric So, FHKCA FHKAM

Phone

29588888

Ext

6202

sohke@ha.org.hk

First Name & Middle Initial & Last Name & Degree

Vincent Ho, FANZCA FHKCA

First Name & Middle Initial & Last Name & Degree

Wai Hong Yuen, FHKCOS FHKAM

First Name & Middle Initial & Last Name & Degree

John Wong, FHKCOS FHKAM

First Name & Middle Initial & Last Name & Degree

David Chong, FHKCA FHKAM

First Name & Middle Initial & Last Name & Degree

Eric So, FHKCA FHKAM

First Name & Middle Initial & Last Name & Degree

Loretta Leung, FHKCA FHKAM

First Name & Middle Initial & Last Name & Degree

Dennis Wan, FHKCA FHKAM

First Name & Middle Initial & Last Name & Degree

Grace Hui, FHKCA FHKAM

12. IPD Sharing Statement

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

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