Osteoarthritis,KneeNCT01042093
Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)
A study testing Ropivacaine, Toradol and Clonidine in people with Osteoarthritis,Knee, run by Towson Orthopaedic Associates.
Trial summary
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis,Knee
- What is being tested?
- Ropivacaine, Toradol and Clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and Women aged 30 to 85 years
- Voluntary, written informed consent given to participate in this clinical investigation
Who cannot join
- Pregnant or lactating women
- Presence of allergies or contraindication to any medications indicated in the study
- Contraindication to or failure of spinal anesthesia
- Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
- Patients with a diagnosis of inflammatory arthritis
- Previous major bone surgery in the operative knee
- Simultaneous, bilateral TKRs
About this study
Official title: Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.
The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.
Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.
Read the detailed description
Data Collection:
Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively.
Variables
Pre-operative Collection:
- Vital signs
- Hb/Hct
- Age
- Sex
- BMI
- WOMAC Score - Screen Failure at 36 or 12
- Visual Analog Scale (VAS)
Intra-operative Collection:
- Duration of surgery
- Tourniquet time
- Time of periarticular injection
Post-operative Collection:
- Pain Scores in the inpatient post-anesthesia care unit (PACU) using the 1- to 10- point Visual Analog Scale (VAS) an admission to unit, 1 hour, 2 hour, and on discharge.
- VAS pain scores every 8 hours on the Orthopaedic floor
- Use of supplementary narcotics
- Use of anti-emetics
- Serious Adverse Events (SAE) including deep vein thrombosis (DVT) formation, pulmonary embolism (PE), myocardial infarct or other serious cardiac event, excessive bleeding
- Length of hospital stay
- Requirement for inpatient rehabilitation versus discharge home
- Hours/Days to straight leg raise -POD 1, 2, 3 by MD on rounds.
- Days to independent ambulation
- Hemoglobin and Hematocrit levels on post-operative days one and two
- Presence/Absence of Bowel/Bladder Function
Data to be Collected by Physical Therapist: POD 1, 2, 3, Numerical Rating Scale (NRS) Pain with Ambulation
- Use of Assisted Devices
- Distance walked
- Range of Motion(ROM) (using Goniometer)- active and passive.
Treatment Periods Screening Visit Day 0 - Day of surgery Visit Day 1, 2, 3 (Post-operative days 1, 2, and 3) 6 Week visit in Office
- Conditions
- Osteoarthritis,Knee
- Being tested
- Ropivacaine, Toradol, Clonidine, Epinephrine
- Keywords
- Analgesia, postoperative pain, periarticular, arthroplasty, pain management
- Medical subject headings
- Osteoarthritis, Knee, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called periarticular injection
Ropivacaine 5mg/ml (49.25 ml)
ToradolDrug
Also called periarticular injection
Toradol 30mg/ml (1 ml)
ClonidineDrug
Also called periarticular injection
Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
EpinephrineDrug
Also called periarticular injection
Epinephrine 1 mg/ml (0.5 ml)
| Study group | Role | What they receive |
|---|---|---|
| ROP/EPI/TOR/CLO | Active comparator | Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) Receives: Drug: Ropivacaine; Drug: Toradol; Drug: Clonidine; Drug: Epinephrine |
| ROP/EPI/TOR | Active comparator | Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Receives: Drug: Ropivacaine; Drug: Toradol; Drug: Epinephrine |
| ROP/EPI/CLO | Active comparator | Ropivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) Receives: Drug: Ropivacaine; Drug: Clonidine; Drug: Epinephrine |
| ROP/EPI | Active comparator | Ropivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml) Receives: Drug: Ropivacaine; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain Scores During Hospitalization.
Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.
Measured: 2 days after surgery
Secondary outcomes (2)
Narcotic Consumption During Hospitalization
A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.
Measured: 4 days
Knee Society Pain Scores at 6 Week Follow-up Appointment
Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis,KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Towson Orthopaedic Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David F. Dalury, MD, Towson Orthopaedic Associates
- Investigators
- David F. Dalury, MD, Principal investigator, Towson Orthpaedic Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042093
- Sponsor's protocol ID
- 1113723
- Status last verified
- Sep 2013
- First submitted
- 4 Jan 2010
- Last updated
- 8 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multimodal Perioperative Analgesia Protocol With Periarticular Drug Injection in Total Knee Arthroplasty: A Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT01042093
- Acronym / sponsor ID
- 1113723
- Conditions
- Osteoarthritis,Knee
- Keywords
- Analgesia, postoperative pain, periarticular, arthroplasty, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Towson Orthopaedic AssociatesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Posted 8 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.
The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.
Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.
Detailed description
Data Collection:
Data will be collected from the patient's pre-operative office visit, up to six weeks post-operatively.
Variables
Pre-operative Collection:
- Vital signs
- Hb/Hct
- Age
- Sex
- BMI
- WOMAC Score - Screen Failure at 36 or 12
- Visual Analog Scale (VAS)
Intra-operative Collection:
- Duration of surgery
- Tourniquet time
- Time of periarticular injection
Post-operative Collection:
- Pain Scores in the inpatient post-anesthesia care unit (PACU) using the 1- to 10- point Visual Analog Scale (VAS) an admission to unit, 1 hour, 2 hour, and on discharge.
- VAS pain scores every 8 hours on the Orthopaedic floor
- Use of supplementary narcotics
- Use of anti-emetics
- Serious Adverse Events (SAE) including deep vein thrombosis (DVT) formation, pulmonary embolism (PE), myocardial infarct or other serious cardiac event, excessive bleeding
- Length of hospital stay
- Requirement for inpatient rehabilitation versus discharge home
- Hours/Days to straight leg raise -POD 1, 2, 3 by MD on rounds.
- Days to independent ambulation
- Hemoglobin and Hematocrit levels on post-operative days one and two
- Presence/Absence of Bowel/Bladder Function
Data to be Collected by Physical Therapist: POD 1, 2, 3, Numerical Rating Scale (NRS) Pain with Ambulation
- Use of Assisted Devices
- Distance walked
- Range of Motion(ROM) (using Goniometer)- active and passive.
Treatment Periods Screening Visit Day 0 - Day of surgery Visit Day 1, 2, 3 (Post-operative days 1, 2, and 3) 6 Week visit in Office
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ROP/EPI/TOR/CLO | Active comparator | Drug: Ropivacaine, Drug: Toradol, Drug: Clonidine, Drug: EpinephrineRopivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| ROP/EPI/TOR | Active comparator | Drug: Ropivacaine, Drug: Toradol, Drug: EpinephrineRopivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) |
| ROP/EPI/CLO | Active comparator | Drug: Ropivacaine, Drug: Clonidine, Drug: EpinephrineRopivacaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml) |
| ROP/EPI | Active comparator | Drug: Ropivacaine, Drug: EpinephrineRopivacaine 5mg/ml (49.25ml) Epinephrine 1 mg/ml (0.5 ml) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and Women aged 30 to 85 years
- Voluntary, written informed consent given to participate in this clinical investigation
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Presence of allergies or contraindication to any medications indicated in the study
- Contraindication to or failure of spinal anesthesia
- Known drug or alcohol abuse or psychologic disorder that could affect follow-up care or treatment outcomes
- Patients with a diagnosis of inflammatory arthritis
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 |
|---|---|---|
| RopivacaineAlso: periarticular injectionRopivacaine 5mg/ml (49.25 ml) | Drug | ROP/EPI, ROP/EPI/CLO, ROP/EPI/TOR, ROP/EPI/TOR/CLO |
| ToradolAlso: periarticular injectionToradol 30mg/ml (1 ml) | Drug | ROP/EPI/TOR, ROP/EPI/TOR/CLO |
| ClonidineAlso: periarticular injectionClonidine 0.1 mg/ml (0.08mg - 0.8 ml) | Drug | ROP/EPI/CLO, ROP/EPI/TOR/CLO |
| EpinephrineAlso: periarticular injectionEpinephrine 1 mg/ml (0.5 ml) | Drug | ROP/EPI, ROP/EPI/CLO, ROP/EPI/TOR, ROP/EPI/TOR/CLO |
Primary outcome
Numerical Rating Scale (NRS) Pain Scores During Hospitalization.
Time frame: 2 days after surgery
Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.
2 secondary outcomes
Narcotic Consumption During Hospitalization
Time frame: 4 days
Knee Society Pain Scores at 6 Week Follow-up Appointment
Time frame: 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David F. Dalury, MD principal investigator
Towson Orthpaedic Associates
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine, Toradol and Clonidine in people with Osteoarthritis,Knee, run by Towson Orthopaedic Associates.
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 2 inclusion and 7 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numerical Rating Scale (NRS) Pain Scores During Hospitalization. (time frame: 2 days after surgery). 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 8 Nov 2013.