Total Hip and Knee ArthroplastyPhase 4NCT02543801
A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
A Phase 4 study testing Liposomal Bupivacaine, Ropivacaine and Bupivacaine in people with Total Hip and Knee Arthroplasty, run by Kootenai Health.
Trial summary
This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Total Hip and Knee Arthroplasty
- What is being tested?
- Liposomal Bupivacaine, Ropivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2016to 21 Aug 2018
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)
Who cannot join
- Current use of opioid drugs
- Revision surgery
- Surgical complication (femoral fracture with implant insertion)
- Inability to provide Informed Consent
About this study
Official title: A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.
Read the detailed description
A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.
Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.
- Conditions
- Total Hip and Knee Arthroplasty
- Being tested
- Liposomal Bupivacaine, Ropivacaine, Bupivacaine, Clonidine, Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Exparel
Periarticular injection
RopivacaineDrug
Also called Naropin
Periarticular injection
BupivacaineDrug
Also called Marcaine
Included as an element of the Liposomal bupivacaine intervention periarticular injection
ClonidineDrug
Also called Duraclon
Included as an element of both interventions as a standard of care periarticular injection
KetorolacDrug
Also called Toradol
Included as an element of both interventions as a standard of care periarticular injection
EpinephrineDrug
Also called Adrenaline
Included as an element of both interventions as a standard of care periarticular injection
| Study group | Role | What they receive |
|---|---|---|
| Hip Cohort Liposomal Bupivacaine | Active comparator | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Receives: Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine |
| Hip Cohort Ropivacaine | Active comparator | Ropivacaine Clonidine Epinephrine Ketorolac Receives: Drug: Ropivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine |
| Knee Cohort Liposomal Bupivacaine | Active comparator | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Receives: Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine |
| Knee Cohort Ropivacaine | Active comparator | Ropivacaine Clonidine Epinephrine Ketorolac Receives: Drug: Ropivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome
Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated.
Measured: Starting post operatively and then every four hours up to 48 hours
Secondary outcomes (2)
Narcotic Consumption
Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours.
Measured: Starting immediately post operatively up to 48 hours
Length of Stay
Measured in hours
Measured: Start of surgery to hospital discharge up to 140 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start25 Jan 2016
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
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 Total Hip and Knee ArthroplastyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kootenai Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe Bowen, MD, Principal investigator, Kootenai Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543801
- Sponsor's protocol ID
- IRB2022
- Status last verified
- Oct 2019
- First submitted
- 21 Aug 2015
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02543801
- Acronym / sponsor ID
- IRB2022
- Conditions
- Total Hip and Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Kootenai HealthUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.
Detailed description
A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.
Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hip Cohort Liposomal Bupivacaine | Active comparator | Drug: Liposomal Bupivacaine, Drug: Bupivacaine, Drug: Clonidine, Drug: Ketorolac, Drug: EpinephrineLiposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac |
| Hip Cohort Ropivacaine | Active comparator | Drug: Ropivacaine, Drug: Clonidine, Drug: Ketorolac, Drug: EpinephrineRopivacaine Clonidine Epinephrine Ketorolac |
| Knee Cohort Liposomal Bupivacaine | Active comparator | Drug: Liposomal Bupivacaine, Drug: Bupivacaine, Drug: Clonidine, Drug: Ketorolac, Drug: EpinephrineLiposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac |
| Knee Cohort Ropivacaine | Active comparator | Drug: Ropivacaine, Drug: Clonidine, Drug: Ketorolac, Drug: EpinephrineRopivacaine Clonidine Epinephrine Ketorolac |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)
Key exclusion criteria (4 listed)
- Current use of opioid drugs
- Revision surgery
- Surgical complication (femoral fracture with implant insertion)
- Inability to provide Informed Consent
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 |
|---|---|---|
| Liposomal BupivacaineAlso: ExparelPeriarticular injection | Drug | Hip Cohort Liposomal Bupivacaine, Knee Cohort Liposomal Bupivacaine |
| RopivacaineAlso: NaropinPeriarticular injection | Drug | Hip Cohort Ropivacaine, Knee Cohort Ropivacaine |
| BupivacaineAlso: MarcaineIncluded as an element of the Liposomal bupivacaine intervention periarticular injection | Drug | Hip Cohort Liposomal Bupivacaine, Knee Cohort Liposomal Bupivacaine |
| ClonidineAlso: DuraclonIncluded as an element of both interventions as a standard of care periarticular injection | Drug | Hip Cohort Liposomal Bupivacaine, Hip Cohort Ropivacaine, Knee Cohort Liposomal Bupivacaine, Knee Cohort Ropivacaine |
| KetorolacAlso: ToradolIncluded as an element of both interventions as a standard of care periarticular injection | Drug | Hip Cohort Liposomal Bupivacaine, Hip Cohort Ropivacaine, Knee Cohort Liposomal Bupivacaine, Knee Cohort Ropivacaine |
| EpinephrineAlso: AdrenalineIncluded as an element of both interventions as a standard of care periarticular injection | Drug | Hip Cohort Liposomal Bupivacaine, Hip Cohort Ropivacaine, Knee Cohort Liposomal Bupivacaine, Knee Cohort Ropivacaine |
Primary outcome
Pain Score
Time frame: Starting post operatively and then every four hours up to 48 hours
Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated.
2 secondary outcomes
Narcotic Consumption
Time frame: Starting immediately post operatively up to 48 hours
Length of Stay
Time frame: Start of surgery to hospital discharge up to 140 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Total Hip and Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Active, not recruiting
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Arthritis Knee, Arthritis Hip
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
RecruitingObservational study
The Effect of Perioperative Nutritional Care on Recovery After Knee and Hip Replacement Surgery
Postoperative Outcomes, Postoperative Complications
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.
Joe Bowen, MD principal investigator
Kootenai Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivacaine, Ropivacaine and Bupivacaine in people with Total Hip and Knee Arthroplasty, run by Kootenai Health.
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 1 inclusion and 4 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 18 Oct 2019. 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.
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?
Yes. Results are posted in the registry (first posted 18 Oct 2019). 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?
Pain Score (time frame: Starting post operatively and then every four hours up to 48 hours). 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 18 Oct 2019.