OsteoarthritisPhase 4NCT01973530
Comparison of Femoral Nerve Catheter and Adductor Canal Block With Steroid Adjuvant in Total Knee Replacement (TKR)
A Phase 4 study testing adductor canal block and femoral nerve block in people with Osteoarthritis, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- adductor canal block and femoral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Joint Replacement Center, Buddhist Hospital
Kowloon
Eric So, FHKCA FHKAM, 29588888 ext. 6202, sohke@ha.org.hk
Vincent Ho, FANZCA FHKCA
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- adductor canal block, femoral nerve block
- Keywords
- femoral nerve block, adductor canal block, steroid, total knee replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal blockProcedure or surgery
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 blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block | Active comparator | 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) Receives: Procedure: adductor canal block |
| continuous femoral nerve block | Other | 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 Receives: Procedure: femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA morphine or pain rescuer consumption at 24h and 48h postoperative
Measured: 24h and 48h postoperative
Postoperative pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery
Measured: 6h,12h, 24h,48h, 72h after surgery
Quadriceps strength at 24h, 48h, 72h postoperative
using dynamometer (measure in Newton/centimeter square)
Measured: 24h, 48h, 72h postoperative
Secondary outcomes (6)
Patient satisfaction score (0-4)
Measured: upon discharge
Incidence of side effects and complications at postoperative day 0- 4 postoperative
Measured: postoperative period 0-96 hr postoperative
Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay
Measured: upon discharge
postoperative nausea or vomiting
Measured: 0-72h
postoperative pruritis
Measured: 0-72h
Haemastix on call and every 8 hours after surgery for postoperative 24hours for patients
Measured: on call and every 8 hours after surgery for postoperative 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startOct 2014
- Primary completionFeb 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Elizabeth Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hui Kit Man Grace, Queen Elizabeth Hospital, Hong Kong
- Investigators
- Eric So, FHKCA FHKAM, Principal investigator, Queen Elizabeth Hospital, Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973530
- Sponsor's protocol ID
- BHJRC_HK_TKR_Study_2014
- Status last verified
- Sep 2014
- First submitted
- 25 Oct 2013
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01973530
- Acronym / sponsor ID
- BHJRC_HK_TKR_Study_2014
- Conditions
- Osteoarthritis
- Keywords
- femoral nerve block, adductor canal block, steroid, total knee replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Queen Elizabeth Hospital, Hong KongUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adductor canal block | Active comparator | Procedure: adductor canal blockContinuous 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) |
| continuous femoral nerve block | Other | Procedure: femoral nerve blockFemoral 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adductor canal blockContinuous 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) | Procedure or surgery | adductor canal block |
| femoral nerve blockFemoral 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 | Procedure or surgery | continuous femoral nerve block |
Primary outcome
PCA morphine or pain rescuer consumption at 24h and 48h postoperative
Time frame: 24h and 48h postoperative
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
Quadriceps strength at 24h, 48h, 72h postoperative
Time frame: 24h, 48h, 72h postoperative
using dynamometer (measure in Newton/centimeter square)
6 secondary outcomes
Patient satisfaction score (0-4)
Time frame: upon discharge
Incidence of side effects and complications at postoperative day 0- 4 postoperative
Time frame: postoperative period 0-96 hr postoperative
Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay
Time frame: upon discharge
postoperative nausea or vomiting
Time frame: 0-72h
postoperative pruritis
Time frame: 0-72h
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric So, FHKCA FHKAM principal investigator
Queen Elizabeth Hospital, Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adductor canal block and femoral nerve block in people with Osteoarthritis, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric So, FHKCA FHKAM (29588888, sohke@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCA morphine or pain rescuer consumption at 24h and 48h postoperative (time frame: 24h and 48h postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.