OsteoarthritisPhase 3NCT02540070
Evaluation of Motor Sparing Knee Block to Infiltration Analgesia for Pain Following Knee Arthroplasty
A Phase 3 study testing Periarticular, Motor free and Motor free with dex in people with Osteoarthritis and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients undergoing primary total knee replacement will receive either motor sparing knee block to be performed by anesthesia or periarticular local anesthetic infiltration at the end of surgery by surgeons to assess pain relief as well as capacity to ambulate early. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee Arthroplasty, Pain Management
- What is being tested?
- Periarticular, Motor free and Motor free with dex
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Dec 2017
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females of 18-85 years of age, scheduled to undergo elective primary total knee arthroplasty.
- ASA Class I, II, III
- Good contralateral leg strength
Who cannot join
- ASA physical status 4 or above
- Patients who will need hospitalization due to reason other than the planned surgery.
- Psychiatric illnesses.
- Revision knee surgery
- Narcotic dependency
- Extraneous sources of chronic pain
Show all 10Show fewer
- Inability to provide informed consent.
- Allergy to any of the drugs used in the study.
- Contraindications to blocks and multimodal analgesia
- Wheel chair bound
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Hospital, London Health Sciences Centre
London, Ontario, N6A 5A5
Sugantha Ganapathy, FRCPC
James L Howard, FRCSC
About this study
Official title: Ultrasound Guided Motor Sparing Knee Blocks With or Without Dexmedetomidine for Postoperative Analgesia Following Knee Arthroplasty: a Randomized Double Blinded Study
Patients undergoing primary total knee replacement will receive either motor sparing knee block to be performed by anesthesia or periarticular local anesthetic infiltration at the end of surgery by surgeons to assess pain relief as well as capacity to ambulate early. The motor sparing knee block will be performed prior to surgery using ultrasonography and the effect of adding dexmedetomidine, an alpha 2 agonist to the injectate with regards to prolonging the duration of analgesia will be assessed.
Read the detailed description
This prospective randomised double blind study will be conducted on 90 patients undergoing primary total knee arthroplasties of American society of anesthesiologists physical status (ASA) 1-3 class. Patients will be educated regarding verbal rating score (0=no pain; 10= worst pain ever) and postoperative rehabilitation exercises by the physiotherapy. Preoperative motor power will be recorded by a physiotherapist in all patients. All patients will receive pre-operative multimodal analgesia with Tylenol, Naproxen, gabapentin and granisetron which will be continued for at least 5 postoperative days. Patients will be grouped according to the study arm as group 1 (periarticular infiltration of 100 ml of 0.3% ropivacaine with 30 mg of ketorolac, 10 mg morphine and 2.5µg/ml of epinephrine), group 2 (60 ml of 0.5% ropivacaine with 30 mg of ketorolac, 10 mg morphine and 2.5µg/ml of epinephrine) or group 3 (60 ml of 0.5% ropivacaine with 30 mg of ketorolac, 10 mg morphine and 1µg/Kg of dexmedetomidine).
Pre-procedural scan will identify suitable location to perform the three injections. The continuous adductor canal block will be performed under ultrasound guidance in the supine position with the leg in external rotation. The femoral artery is traced from the groin region under the Sartorius muscle until the superior geniculate artery is seen to take off from the femoral artery. This will mark the site of final catheter tip location. The probe will be rotated 900 and moved cephalad tracing the Sartorius and the femoral artery in the long axis till 8cms proximally which will be marked as the needle entry point. The intermediate cutaneous nerve of thigh usually travels as a dual nerve between the Sartorius and rectus femoris above the fascia lata which is identified at this point. Following sterile precautions, the skin will be anesthetized with 1% lidocaine and an 8 cm block needle will be inserted out of plane with the artery in short axis under the Sartorius. The needle will be initially directed laterally to lie above the fascia lata between the Sartorius and rectus femoris muscle and 5 ml of study drug will be injected while withdrawing the needle. The needle is then redirected to enter the fascia of the Sartorius to deliver an additional 5ml of the study drug. The needle is then advanced till the needle tip is seen to lie adjacent to the femoral artery under the Sartorius. Following this, the US probe is rotated to see the Sartorius in the long axis with the artery in the long axis underneath it. The needle is advanced hydrodissecting with 0.5% dextrose until the needle tip is positioned just proximal to the origin of the superior geniculate artery. A block catheter will be inserted 3cms beyond the tip of the needle under US guidance. Following this, 15 ml of test drug will be injected watching for confirmation of STUDY DRUG deposition around the artery. The final catheter tip location will be confirmed with color Doppler as well as pulse wave Doppler and is deemed adequately positioned if seen close to the artery. Following adductor canal block, sartorius will be traced to its origin at the anterior superior iliac spine and lateral cutaneous nerve of thigh will be blocked in the lacuna musculorum between the origin of Sartorius and tensor fascia lata muscle with 10 ml of the study drug. Following the anterior injections, an 8 cms block needle will be inserted near the medial femoral epicondyle under ultrasound guidance and 25 ml of test drug will be injected from the medial epicondyle to the lateral epicondyle between the bone and popliteal artery which constitutes posterior pericapsular injection. Hence, a total volume of 60 ml will be used.
All patients will be enrolled on an intention to treat analysis basis and the block characteristics will be documented on all the aspects of the knee joint by a blinded observer comparing it to the opposite side. Motor power will be tested with a hand held dynamometer before and 20 minutes after the performance of the blocks. Proprioception and vibration will be tested and documented by the same observer before and 20 minutes after the blocks. All patients will receive spinal anesthesia with 15 mg of hyperbaric bupivacaine for the surgery with titrated sedation intraoperatively to a Ramsay sedation score of 3 with propofol 9mg/ml and 1mg/ml of ketamine. The patients will be assessed for pain during rest and activity immediately after the effects of spinal anesthetic wears off (Bromage score of 1), every 2 hourly for 6 hours and at 6, 12 , 24, 36 and 48 AND 72 HOURS. All patients will be evaluated for their readiness to perform physiotherapy after full recovery FROM SPINAL ANESTHESIA (Bromage score of 1), lack of postural hypotension AS ASSESSED BY THE CAREGIVER AND THE PHYSIOTHERAPIST. The adductor canal catheter will be bolused with 10 ml of 0.2% ropivacaine once the patient reports >6/10 anterior knee pain and an infusion will be started at a basal rate of 6ml/Hr with patient controlled boluses (PCRA) of 4ml every 30 minutes as needed. Second rescue analgesia consists of oxycodone 5-10mg every 3-4 hourly. The predominant site of pain will be documented. All patients will be assessed for performance of "Timed up and Go" test at 6 postoperative hours and at discharge. Patients will be deemed to attain discharge readiness if pain and nausea are controlled on oral medications, absence of medical or surgical complications and are able to do five steps in the physiotherapy department. The number of patients that achieved the discharge criteria in each group prior to starting adductor canal infusion will be documented every 6 hourly. WOMAC scores will be collected from the orthopedic database pre-operatively and at three months postoperatively.
Block performance time, pain scores on movement and rest, time to first request and the frequency of analgesic consumption, site of predominant pain, total analgesic consumption every 12 hourly and time to first physiotherapy will be documented. Intraoperative sedation requirement and intraoperative hemodynamics will be obtained from the anesthetic record. Motor strength will be evaluated with a dynamometer for maximum voluntary isometric contraction (MVIC) at 6 hours after the initial block, at 1800 PM on the day of surgery and thereafter at 0800 AM and 1600 PM for the next 72 hours. Time from the block performance/ end of infiltration to the first rescue analgesia will be determined as the total block duration. The time from the arrival in PACU to the attainment of discharge criteria will be determined as the time to readiness for discharge. Patient satisfaction will be documented on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied. Adverse events such as local anesthetic toxicity, symptomatic bradycardia (HR≤ 40), Significant hypotension (< 90mmHg systolic), neurological deficits, respiratory insufficiency will be prospectively collected. The failure rate and the number of attempts will also be recorded.
- Conditions
- Osteoarthritis, Knee Arthroplasty, Pain Management
- Being tested
- Periarticular, Motor free, Motor free with dex, Ropivacaine, epinephrine
- Keywords
- Adductor canal Block, ultrasound, periarticular injections, Dexmedetomidine
- Medical subject headings
- Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeriarticularProcedure or surgery
Motor freeProcedure or surgery
Motor free with dexProcedure or surgery
RopivacaineDrug
epinephrineDrug
morphineDrug
KetorolacDrug
DexmedetomidineDrug
salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Periarticular | Active comparator | Patients in group 1 will receive periarticular infiltration of LA mixture (100 ml) consisting of 0.3% ropivacaine, 2.5 µg/mL of epinephrine, 10 mg of morphine and 30 mg of ketorolac at the end of surgery and sham injections of saline into the motor sparing knee blocks preoperatively. Receives: Procedure: Periarticular; Drug: Ropivacaine; Drug: epinephrine; Drug: morphine; Drug: Ketorolac; Drug: saline |
| Motor free | Experimental | Patients in group 2 will receive motor sparing knee blocks with 0.5% ropivacaine with 2.5 µg/mL of epinephrine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Sham injections of saline (100 ml) will be injected periarticularly at the end of surgery. Receives: Procedure: Motor free; Drug: Ropivacaine; Drug: epinephrine; Drug: morphine; Drug: Ketorolac; Drug: saline |
| Motor free with Dex | Experimental | Patients in group 3 will receive motor sparing knee blocks with 0.5% ropivacaine with 1 µg/Kg of dexmedetomidine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Patients in group 3 will receive sham injections of saline (100 ml) periarticularly at the end of surgery. Receives: Procedure: Motor free with dex; Drug: Ropivacaine; Drug: morphine; Drug: Ketorolac; Drug: Dexmedetomidine; Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
To note the duration of analgesia in the three different arms
Measured: 24 postoperative hour
Secondary outcomes (3)
pain scores on movement
Measured: every 4 hours up to 24 hours
pain scores at rest
Measured: every 4 hours up to 24 hours
discharge criteria
Measured: 6 and 18 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugantha Ganapathy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Sugantha Ganapathy, FRCPC, Principal investigator, LHSC, UWO, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540070
- Sponsor's protocol ID
- 104373
- Status last verified
- Aug 2015
- First submitted
- 17 Mar 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fowler SJ, Christelis N. High volume local infiltration analgesia compared to peripheral nerve block for hip and knee arthroplasty-what is the evidence? Anaesth Intensive Care. 2013 Jul;41(4):458-62. doi: 10.1177/0310057X1304100404.
PubMed 23808503Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
PubMed 23587874
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Motor Sparing Knee Blocks With or Without Dexmedetomidine for Postoperative Analgesia Following Knee Arthroplasty: a Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT02540070
- Acronym / sponsor ID
- 104373
- Conditions
- Osteoarthritis, Knee Arthroplasty, Pain Management
- Keywords
- Adductor canal Block, ultrasound, periarticular injections, Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 3 Sep 2015 (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.
Patients undergoing primary total knee replacement will receive either motor sparing knee block to be performed by anesthesia or periarticular local anesthetic infiltration at the end of surgery by surgeons to assess pain relief as well as capacity to ambulate early. The motor sparing knee block will be performed prior to surgery using ultrasonography and the effect of adding dexmedetomidine, an alpha 2 agonist to the injectate with regards to prolonging the duration of analgesia will be assessed.
Detailed description
This prospective randomised double blind study will be conducted on 90 patients undergoing primary total knee arthroplasties of American society of anesthesiologists physical status (ASA) 1-3 class. Patients will be educated regarding verbal rating score (0=no pain; 10= worst pain ever) and postoperative rehabilitation exercises by the physiotherapy. Preoperative motor power will be recorded by a physiotherapist in all patients. All patients will receive pre-operative multimodal analgesia with Tylenol, Naproxen, gabapentin and granisetron which will be continued for at least 5 postoperative days. Patients will be grouped according to the study arm as group 1 (periarticular infiltration of 100 ml of 0.3% ropivacaine with 30 mg of ketorolac, 10 mg morphine and 2.5µg/ml of epinephrine), group 2 (60 ml of 0.5% ropivacaine with 30 mg of ketorolac, 10 mg morphine and 2.5µg/ml of epinephrine) or group 3 (60 ml of 0.5% ropivacaine with 30 mg of ketorolac, 10 mg morphine and 1µg/Kg of dexmedetomidine).
Pre-procedural scan will identify suitable location to perform the three injections. The continuous adductor canal block will be performed under ultrasound guidance in the supine position with the leg in external rotation. The femoral artery is traced from the groin region under the Sartorius muscle until the superior geniculate artery is seen to take off from the femoral artery. This will mark the site of final catheter tip location. The probe will be rotated 900 and moved cephalad tracing the Sartorius and the femoral artery in the long axis till 8cms proximally which will be marked as the needle entry point. The intermediate cutaneous nerve of thigh usually travels as a dual nerve between the Sartorius and rectus femoris above the fascia lata which is identified at this point. Following sterile precautions, the skin will be anesthetized with 1% lidocaine and an 8 cm block needle will be inserted out of plane with the artery in short axis under the Sartorius. The needle will be initially directed laterally to lie above the fascia lata between the Sartorius and rectus femoris muscle and 5 ml of study drug will be injected while withdrawing the needle. The needle is then redirected to enter the fascia of the Sartorius to deliver an additional 5ml of the study drug. The needle is then advanced till the needle tip is seen to lie adjacent to the femoral artery under the Sartorius. Following this, the US probe is rotated to see the Sartorius in the long axis with the artery in the long axis underneath it. The needle is advanced hydrodissecting with 0.5% dextrose until the needle tip is positioned just proximal to the origin of the superior geniculate artery. A block catheter will be inserted 3cms beyond the tip of the needle under US guidance. Following this, 15 ml of test drug will be injected watching for confirmation of STUDY DRUG deposition around the artery. The final catheter tip location will be confirmed with color Doppler as well as pulse wave Doppler and is deemed adequately positioned if seen close to the artery. Following adductor canal block, sartorius will be traced to its origin at the anterior superior iliac spine and lateral cutaneous nerve of thigh will be blocked in the lacuna musculorum between the origin of Sartorius and tensor fascia lata muscle with 10 ml of the study drug. Following the anterior injections, an 8 cms block needle will be inserted near the medial femoral epicondyle under ultrasound guidance and 25 ml of test drug will be injected from the medial epicondyle to the lateral epicondyle between the bone and popliteal artery which constitutes posterior pericapsular injection. Hence, a total volume of 60 ml will be used.
All patients will be enrolled on an intention to treat analysis basis and the block characteristics will be documented on all the aspects of the knee joint by a blinded observer comparing it to the opposite side. Motor power will be tested with a hand held dynamometer before and 20 minutes after the performance of the blocks. Proprioception and vibration will be tested and documented by the same observer before and 20 minutes after the blocks. All patients will receive spinal anesthesia with 15 mg of hyperbaric bupivacaine for the surgery with titrated sedation intraoperatively to a Ramsay sedation score of 3 with propofol 9mg/ml and 1mg/ml of ketamine. The patients will be assessed for pain during rest and activity immediately after the effects of spinal anesthetic wears off (Bromage score of 1), every 2 hourly for 6 hours and at 6, 12 , 24, 36 and 48 AND 72 HOURS. All patients will be evaluated for their readiness to perform physiotherapy after full recovery FROM SPINAL ANESTHESIA (Bromage score of 1), lack of postural hypotension AS ASSESSED BY THE CAREGIVER AND THE PHYSIOTHERAPIST. The adductor canal catheter will be bolused with 10 ml of 0.2% ropivacaine once the patient reports >6/10 anterior knee pain and an infusion will be started at a basal rate of 6ml/Hr with patient controlled boluses (PCRA) of 4ml every 30 minutes as needed. Second rescue analgesia consists of oxycodone 5-10mg every 3-4 hourly. The predominant site of pain will be documented. All patients will be assessed for performance of "Timed up and Go" test at 6 postoperative hours and at discharge. Patients will be deemed to attain discharge readiness if pain and nausea are controlled on oral medications, absence of medical or surgical complications and are able to do five steps in the physiotherapy department. The number of patients that achieved the discharge criteria in each group prior to starting adductor canal infusion will be documented every 6 hourly. WOMAC scores will be collected from the orthopedic database pre-operatively and at three months postoperatively.
Block performance time, pain scores on movement and rest, time to first request and the frequency of analgesic consumption, site of predominant pain, total analgesic consumption every 12 hourly and time to first physiotherapy will be documented. Intraoperative sedation requirement and intraoperative hemodynamics will be obtained from the anesthetic record. Motor strength will be evaluated with a dynamometer for maximum voluntary isometric contraction (MVIC) at 6 hours after the initial block, at 1800 PM on the day of surgery and thereafter at 0800 AM and 1600 PM for the next 72 hours. Time from the block performance/ end of infiltration to the first rescue analgesia will be determined as the total block duration. The time from the arrival in PACU to the attainment of discharge criteria will be determined as the time to readiness for discharge. Patient satisfaction will be documented on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied. Adverse events such as local anesthetic toxicity, symptomatic bradycardia (HR≤ 40), Significant hypotension (< 90mmHg systolic), neurological deficits, respiratory insufficiency will be prospectively collected. The failure rate and the number of attempts will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periarticular | Active comparator | Procedure: Periarticular, Drug: Ropivacaine, Drug: epinephrine, Drug: morphine, Drug: Ketorolac, Drug: salinePatients in group 1 will receive periarticular infiltration of LA mixture (100 ml) consisting of 0.3% ropivacaine, 2.5 µg/mL of epinephrine, 10 mg of morphine and 30 mg of ketorolac at the end of surgery and sham injections of saline into the motor sparing knee blocks preoperatively. |
| Motor free | Experimental | Procedure: Motor free, Drug: Ropivacaine, Drug: epinephrine, Drug: morphine, Drug: Ketorolac, Drug: salinePatients in group 2 will receive motor sparing knee blocks with 0.5% ropivacaine with 2.5 µg/mL of epinephrine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Sham injections of saline (100 ml) will be injected periarticularly at the end of surgery. |
| Motor free with Dex | Experimental | Procedure: Motor free with dex, Drug: Ropivacaine, Drug: morphine, Drug: Ketorolac, Drug: Dexmedetomidine, Drug: salinePatients in group 3 will receive motor sparing knee blocks with 0.5% ropivacaine with 1 µg/Kg of dexmedetomidine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Patients in group 3 will receive sham injections of saline (100 ml) periarticularly at the end of surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and females of 18-85 years of age, scheduled to undergo elective primary total knee arthroplasty.
- ASA Class I, II, III
- Good contralateral leg strength
Key exclusion criteria (10 listed)
- ASA physical status 4 or above
- Patients who will need hospitalization due to reason other than the planned surgery.
- Psychiatric illnesses.
- Revision knee surgery
- Narcotic dependency
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 |
|---|---|---|
| Periarticular | Procedure or surgery | Periarticular |
| Motor free | Procedure or surgery | Motor free |
| Motor free with dex | Procedure or surgery | Motor free with Dex |
| Ropivacaine | Drug | Motor free, Motor free with Dex, Periarticular |
| epinephrine | Drug | Motor free, Periarticular |
| morphine | Drug | Motor free, Motor free with Dex, Periarticular |
| Ketorolac | Drug | Motor free, Motor free with Dex, Periarticular |
| Dexmedetomidine | Drug | Motor free with Dex |
| saline | Drug | Motor free, Motor free with Dex, Periarticular |
Primary outcome
Duration of analgesia
Time frame: 24 postoperative hour
To note the duration of analgesia in the three different arms
3 secondary outcomes
pain scores on movement
Time frame: every 4 hours up to 24 hours
pain scores at rest
Time frame: every 4 hours up to 24 hours
discharge criteria
Time frame: 6 and 18 postoperative hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Background: PubMed 23808503Fowler SJ, Christelis N. High volume local infiltration analgesia compared to peripheral nerve block for hip and knee arthroplasty-what is the evidence? Anaesth Intensive Care. 2013 Jul;41(4):458-62. doi: 10.1177/0310057X1304100404.
- Background: PubMed 23587874Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Sugantha Ganapathy, FRCPC principal investigator
LHSC, UWO, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Periarticular, Motor free and Motor free with dex in people with Osteoarthritis and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 10 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 15 Nov 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sugantha Ganapathy, FRCPC (519-685-8500 ext. 35115, Sugantha.Ganapathy@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: 24 postoperative hour). 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 NCT02540070, which also lists 2 linked publications.
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 15 Nov 2016.