Knee ArthroplastyNCT02166710
Effect of Adductor Canal Nerve Block Compared to a Simulated Block on Quadriceps Strength Following Knee Arthroplasty
A study testing Adductor canal femoral nerve block and Simulated nerve blockade in people with Knee Arthroplasty, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis. This major surgery is associated with a reduction in knee extensor muscle strength persisting several weeks after surgery. This decrease in strength correlates with poor functional recovery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Adductor canal femoral nerve block and Simulated nerve blockade
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective unilateral total knee arthroplasty
- Ability to complete the KOOS questionnaire
- American Society of Anesthesiologists (ASA) class 1-3
Who cannot join
- Contraindication to the adductor canal block (local infection, allergy to local anesthetics)
- Surgery to be performed under general anesthesia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Effect of Adductor Canal Femoral Nerve Block Compared to a Simulated Block on Knee Extensor Muscle Strength Following Total Knee Arthroplasty
Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis. This major surgery is associated with a reduction in knee extensor muscle strength persisting several weeks after surgery. This decrease in strength correlates with poor functional recovery. Its cause is multifactorial, including a deficit of the quadriceps activation, an acute postoperative atrophy of the muscle and an important limitation related to postoperative pain.
Peripheral nerve blocks using local anesthetics are frequently used for postoperative analgesia following TKA. Femoral nerve blockade reduces pain and opioid consumption and allows early passive mobilization after surgery. This block also facilitates functional recovery and allows early discharge from the hospital. However, blocks involving the proximal femoral nerve contribute to quadriceps weakness for the duration of nerve blockade. Quadriceps weakness, in turn, results in functional impairment and increases recovery time. A possible long-term quadriceps weakness associated with the femoral nerve block has even been suggested in a recently published abstract. Hence, there is a need for an alternative technique that could minimize postoperative pain as well as the femoral nerve block without causing weakness of the quadriceps muscle.
Read more
Femoral nerve block performed at the level of the adductor canal seems to be a promising alternative to the classic inguinal approach of the femoral nerve block. Studies comparing femoral nerve block performed at the canal adductor level to the inguinal approach reported a similar quality of analgesia, a reduction in motor block and a better functional recovery in the early postoperative period in the canal adductor block group. The long-term effect of femoral nerve block performed at the level of the adductor canal on knee extensor strength after surgery remains to be studied.
This study will assess knee extensor muscle strength (principally quadriceps muscle) at 24h, 48h and 6 weeks following TKA in patients having a femoral nerve block at the adductor canal level compared to a simulated block.
Hypothesis: The adductor canal block will allow superior recovery of knee extensor muscle strength when compared to a simulated block at 6 weeks after total knee arthroplasty.
Read the detailed description
On arrival in the operating room, patients will be randomly assigned to receive an adductor canal block under ultrasound guidance or a simulated block.
In the adductor canal block group, a 18 Gauge Tuohy needle will be inserted and its position in the adductor canal adjacent to the femoral artery will be confirmed using ultrasound guidance. Once the adequacy of the position is confirmed, the anesthesiologist will administer 15 mL of bupivacaine 0.25% with epinephrine in divided doses and examine the quality of its spread. A 20 Gauge polyamide catheter will be inserted at 2 cm in the space. The needle will then be withdrawn and the catheter will be fixed in place. Three mL of the same mixture of local anesthetics will be administered through the catheter and the anesthesiologist will observe the quality of its distribution.
In the simulated block group, the insertion of the Tuohy needle and the injection of 15 mL of bupivacaine 0.25% with epinephrine will be simulated. The insertion of the polyamide catheter, the withdrawal of the needle and the injection of local anesthetics through the catheter will also be simulated.
Surgery will be performed under spinal anesthesia. A standardized dose of bupivacaine and morphine will be administered for spinal anesthesia.
In both groups, an infusion of local anesthetics will be initiated on arrival in the recovery room and will continue for the first 48 hours. To preserve the blinding in the simulated block group, a Luer-lock connector and a 50 mL empty pouch of intravenous fluids will be affixed to the catheter to collect the infused local anesthetics. The empty pouch will be inserted under the opaque dressing. Patients in the adductor canal block will receive an infusion of bupivacaine 0.125% at 12 mL/h and patients in the simulated block group will have an infusion of the same medication but at an infusion rate of 1 mL/h. The infusion rate will be hidden from the patient. Multimodal analgesia will be used in all patients.
Patients will be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire before and 6 weeks following surgery.
Knee extensor muscle strength will be measured using a hand-held dynamometer pre-operatively and 24 hours, 48 hours and 6 weeks following surgery. Pain scores at rest and during strength assessment will be collected. Opioids consumption and side-effects attributable to analgesia will be recorded. Patients will be asked to rate their global satisfaction regarding the quality of analgesia 48 hours after surgery. Time to discharge will be recorded.
- Conditions
- Knee Arthroplasty
- Being tested
- Adductor canal femoral nerve block, Simulated nerve blockade
- Keywords
- Knee arthroplasty, Adductor canal block, Quadriceps strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal femoral nerve blockDevice
A 18 Gauge Tuohy needle will be inserted and its position will be confirmed using ultrasound guidance. Once the adequacy of the position is confirmed, the anesthesiologist will administer 15 mL of bupivacaine 0.25% with epinephrine in divided doses and examine the quality of its spread. A 20 Gauge polyamide catheter will be inserted at 2 cm in the space. The needle will then be withdrawn and the catheter will be fixed in place. Three mL of the same mixture of local anesthetics will be administered through the catheter and the anesthesiologist will observe the quality of its distribution. Bupivacaine 0.125% will be administered through the catheter using an infusion pump for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points.
Simulated nerve blockadeDevice
The insertion of the Tuohy needle and the injection of 15 mL of bupivacaine 0.25% with epinephrine will be simulated. The insertion of the polyamide catheter, the withdrawal of the needle and the injection of local anesthetics through the catheter will also be simulated. The infusion of bupivacaine 0.125% will also be simulated for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points.
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal femoral nerve blockade | Experimental | Patients will receive continuous adductor canal femoral nerve blockade for 48 hours with a catheter connected to a pump infusing bupivacaine 0.125% and multi-modal analgesia for pain management following total knee arthroplasty. Knee extensor muscle strength will be measured at different time-points prior and after surgery. Receives: Device: Adductor canal femoral nerve block |
| Simulated nerve blockade | Placebo comparator | Patients will receive a simulated continuous femoral nerve block at the level of the adductor canal for 48 hours with a catheter connected to a pump infusing bupivacaine 0.125% and multi-modal analgesia for pain management following total knee arthroplasty. Knee extensor muscle strength will be measured at different time-points prior and after surgery. Receives: Device: Simulated nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensor muscle strength
Will be measured using a hand-held dynamometer
Measured: 6 weeks after surgery
Secondary outcomes (8)
Knee extensor muscle strength
Will be measured using a hand-held dynamometer
Measured: 24 hours and 48 hours following surgery
Intensity of pain at rest
Will be assessed using a Visual Analog Scale (VAS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
Measured: Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Intensity of pain during extensor muscle strength assessment
Will be assessed using a Visual Analog Scale (VAS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable
Measured: Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Opioid consumption
Measured: 24 and 48 hours following surgery
Side-effects attributable to analgesia
The presence of nausea and emesis will be recorded
Measured: 24 and 48 hours following surgery
Global satisfaction regarding analgesia
Will be assessed using a scale from 1 to 10: 1 being totally dissatisfied and 10 being totally satisfied
Measured: 48 hours following surgery
Physical function in daily life
Will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Measured: Immediately prior to surgery and 6 weeks following surgery
Time to discharge from hospital
Measured: Patients will be followed for the duration of hospital stay, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166710
- Sponsor's protocol ID
- 14.093
- Status last verified
- Jan 2017
- First submitted
- 5 Jun 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams SR. In Response. Anesth Analg. 2018 Sep;127(3):e50-e51. doi: 10.1213/ANE.0000000000003571. No abstract available.
PubMed 29905615
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adductor Canal Femoral Nerve Block Compared to a Simulated Block on Knee Extensor Muscle Strength Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02166710
- Acronym / sponsor ID
- 14.093
- Conditions
- Knee Arthroplasty
- Keywords
- Knee arthroplasty, Adductor canal block, Quadriceps strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jun 2014 (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.
Total knee arthroplasty (TKA) is a frequent and effective surgery for knee osteoarthritis. This major surgery is associated with a reduction in knee extensor muscle strength persisting several weeks after surgery. This decrease in strength correlates with poor functional recovery. Its cause is multifactorial, including a deficit of the quadriceps activation, an acute postoperative atrophy of the muscle and an important limitation related to postoperative pain.
Peripheral nerve blocks using local anesthetics are frequently used for postoperative analgesia following TKA. Femoral nerve blockade reduces pain and opioid consumption and allows early passive mobilization after surgery. This block also facilitates functional recovery and allows early discharge from the hospital. However, blocks involving the proximal femoral nerve contribute to quadriceps weakness for the duration of nerve blockade. Quadriceps weakness, in turn, results in functional impairment and increases recovery time. A possible long-term quadriceps weakness associated with the femoral nerve block has even been suggested in a recently published abstract. Hence, there is a need for an alternative technique that could minimize postoperative pain as well as the femoral nerve block without causing weakness of the quadriceps muscle.
Femoral nerve block performed at the level of the adductor canal seems to be a promising alternative to the classic inguinal approach of the femoral nerve block. Studies comparing femoral nerve block performed at the canal adductor level to the inguinal approach reported a similar quality of analgesia, a reduction in motor block and a better functional recovery in the early postoperative period in the canal adductor block group. The long-term effect of femoral nerve block performed at the level of the adductor canal on knee extensor strength after surgery remains to be studied.
This study will assess knee extensor muscle strength (principally quadriceps muscle) at 24h, 48h and 6 weeks following TKA in patients having a femoral nerve block at the adductor canal level compared to a simulated block.
Hypothesis: The adductor canal block will allow superior recovery of knee extensor muscle strength when compared to a simulated block at 6 weeks after total knee arthroplasty.
Detailed description
On arrival in the operating room, patients will be randomly assigned to receive an adductor canal block under ultrasound guidance or a simulated block.
In the adductor canal block group, a 18 Gauge Tuohy needle will be inserted and its position in the adductor canal adjacent to the femoral artery will be confirmed using ultrasound guidance. Once the adequacy of the position is confirmed, the anesthesiologist will administer 15 mL of bupivacaine 0.25% with epinephrine in divided doses and examine the quality of its spread. A 20 Gauge polyamide catheter will be inserted at 2 cm in the space. The needle will then be withdrawn and the catheter will be fixed in place. Three mL of the same mixture of local anesthetics will be administered through the catheter and the anesthesiologist will observe the quality of its distribution.
In the simulated block group, the insertion of the Tuohy needle and the injection of 15 mL of bupivacaine 0.25% with epinephrine will be simulated. The insertion of the polyamide catheter, the withdrawal of the needle and the injection of local anesthetics through the catheter will also be simulated.
Surgery will be performed under spinal anesthesia. A standardized dose of bupivacaine and morphine will be administered for spinal anesthesia.
In both groups, an infusion of local anesthetics will be initiated on arrival in the recovery room and will continue for the first 48 hours. To preserve the blinding in the simulated block group, a Luer-lock connector and a 50 mL empty pouch of intravenous fluids will be affixed to the catheter to collect the infused local anesthetics. The empty pouch will be inserted under the opaque dressing. Patients in the adductor canal block will receive an infusion of bupivacaine 0.125% at 12 mL/h and patients in the simulated block group will have an infusion of the same medication but at an infusion rate of 1 mL/h. The infusion rate will be hidden from the patient. Multimodal analgesia will be used in all patients.
Patients will be asked to complete the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire before and 6 weeks following surgery.
Knee extensor muscle strength will be measured using a hand-held dynamometer pre-operatively and 24 hours, 48 hours and 6 weeks following surgery. Pain scores at rest and during strength assessment will be collected. Opioids consumption and side-effects attributable to analgesia will be recorded. Patients will be asked to rate their global satisfaction regarding the quality of analgesia 48 hours after surgery. Time to discharge will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal femoral nerve blockade | Experimental | Device: Adductor canal femoral nerve blockPatients will receive continuous adductor canal femoral nerve blockade for 48 hours with a catheter connected to a pump infusing bupivacaine 0.125% and multi-modal analgesia for pain management following total knee arthroplasty. Knee extensor muscle strength will be measured at different time-points prior and after surgery. |
| Simulated nerve blockade | Placebo comparator | Device: Simulated nerve blockadePatients will receive a simulated continuous femoral nerve block at the level of the adductor canal for 48 hours with a catheter connected to a pump infusing bupivacaine 0.125% and multi-modal analgesia for pain management following total knee arthroplasty. Knee extensor muscle strength will be measured at different time-points prior and after surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective unilateral total knee arthroplasty
- Ability to complete the KOOS questionnaire
- American Society of Anesthesiologists (ASA) class 1-3
Key exclusion criteria (2 listed)
- Contraindication to the adductor canal block (local infection, allergy to local anesthetics)
- Surgery to be performed under general anesthesia
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 femoral nerve blockA 18 Gauge Tuohy needle will be inserted and its position will be confirmed using ultrasound guidance. Once the adequacy of the position is confirmed, the anesthesiologist will administer 15 mL of bupivacaine 0.25% with epinephrine in divided doses and examine the quality of its spread. A 20 Gauge polyamide catheter will be inserted at 2 cm in the space. The needle will then be withdrawn and the catheter will be fixed in place. Three mL of the same mixture of local anesthetics will be administered through the catheter and the anesthesiologist will observe the quality of its distribution. Bupivacaine 0.125% will be administered through the catheter using an infusion pump for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points. | Device | Adductor canal femoral nerve blockade |
| Simulated nerve blockadeThe insertion of the Tuohy needle and the injection of 15 mL of bupivacaine 0.25% with epinephrine will be simulated. The insertion of the polyamide catheter, the withdrawal of the needle and the injection of local anesthetics through the catheter will also be simulated. The infusion of bupivacaine 0.125% will also be simulated for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points. | Device | Simulated nerve blockade |
Primary outcome
Knee extensor muscle strength
Time frame: 6 weeks after surgery
Will be measured using a hand-held dynamometer
8 secondary outcomes
Knee extensor muscle strength
Time frame: 24 hours and 48 hours following surgery
Intensity of pain at rest
Time frame: Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Intensity of pain during extensor muscle strength assessment
Time frame: Immediately prior to surgery and 24 hours,48 hours and 6 weeks following surgery
Opioid consumption
Time frame: 24 and 48 hours following surgery
Side-effects attributable to analgesia
Time frame: 24 and 48 hours following surgery
Global satisfaction regarding analgesia
Time frame: 48 hours following surgery
Physical function in daily life
Time frame: Immediately prior to surgery and 6 weeks following surgery
Time to discharge from hospital
Time frame: Patients will be followed for the duration of hospital stay, an average of 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Derived from this study: PubMed 29905615Williams SR. In Response. Anesth Analg. 2018 Sep;127(3):e50-e51. doi: 10.1213/ANE.0000000000003571. No abstract available.
Related trials for Knee Arthroplasty
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
Anxiety, Osteoarthritis
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.
François Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor canal femoral nerve block and Simulated nerve blockade in people with Knee Arthroplasty, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Feb 2017. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee extensor muscle strength (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166710, which also lists 1 linked publication.
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 1 Feb 2017.