Pain, PostoperativePhase 2NCT03001453
Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management
A Phase 2 study testing Liposomal Bupivacaine, 0.25% Bupivacaine with epinephrine and Saline in people with Pain, Postoperative, run by American Hip Institute at 2 sites in United States.
Trial summary
The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Liposomal Bupivacaine, 0.25% Bupivacaine with epinephrine and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Mar 2016
- Phase
- Phase 2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo primary unilateral total hip replacement
- Patients diagnosed with hip osteoarthritis
- Patients failed to improve with conservative measures
- Patients willing and able to sign informed consent
Who cannot join
- Revision total hip replacement
- Bilateral total hip replacement
- Birmingham hip resurfacing
- Patients with hepatic/kidney disease
- Patients with a known allergy to bupivacaine or other local anesthetics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Adventist Hinsdale Hospital
Hinsdale, Illinois, 60521
American Hip Institute
Westmont, Illinois, 60559
About this study
Official title: Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.
The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.
Read the detailed description
All surgeries were performed by the same orthopaedic surgeon. Two groups, one receiving Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine (LB group) and the other receiving bupivacaine with epinephrine (Control group), will be compared using post-operative pain scores, hospital length of stay, time to ambulation, falls, narcotic use, and narcotic-related adverse effects. Aside from hospital length of stay, all outcomes were recorded for up to 72 hours following surgery. An a priori power analysis was performed to calculate the total number of patients that needed to be enrolled to achieve a minimum 90% power, with the threshold of statistical significance set to 0.05. Based on a previous study reporting a mean oral opioid consumption of 57.04mg ± 25.6 at 24 hours post THR, a mean difference of 17.14mg was considered to be clinically significant. Thus, at least 26 patients were necessary in each group for an adequately powered assessment. The diagnosis for osteoarthritis was determined by patient history, physical examination, and imaging findings. Each patient received a thorough explanation of the protocol, and willing patients signed an informed consent form. All patients underwent a personal preoperative education program regarding pre, intra-, and post-procedural information including physical therapy, expectations, discharge goals, home therapy, and pain management. After written consent was collected, the form was sent to the hospital pharmacy for randomization. Envelopes were randomized, sealed, numbered, and given to the pharmacy staff, ultimately dispensing the envelopes to the nurse in the operating room in numerical order. The pharmacy documented the required information, selected medication, and drug accountability forms according to the contents of the envelopes.
A nurse delivered study drugs to the operating room in a sealed, non-descriptive envelope. During the standard anterior approach procedure, an anesthesiologist administered fentanyl or hydromorphone as needed for analgesia. The local anesthetics were administered after reduction of the implants. Patients in the LB group received 20cc liposomal bupivacaine, 40cc 0.25% bupivacaine with epinephrine, and 20cc of normal saline. Each patient in the control group received 60cc of 0.25% bupivacaine with epinephrine. Using a 20-gauge spinal needle, the local anesthetics were injected using a deep tissue administration technique. Structures innervated by the femoral nerve, superior gluteal nerve, or lateral femoral cutaneous nerve were considered suitable for injection. Throughout administration, frequent aspirations were performed to check for blood and minimize the risk of intravascular injection. The patients, surgical team, and floor staff was blinded to the local anesthetic drugs given.
During hospitalization, patients were observed, evaluated and treated according to postoperative protocols. Patients received opioids for pain management as needed, which was routinely documented by hospital staff. Opioids included fentanyl, hydromorphone, oxycodone, codeine, tramadol, morphine, and hydrocodone. All opioid dosages were converted into morphine equivalent dosages for analysis. Each patient began physical therapy within the first 24 hours postoperatively. Patients were discharged when they were able to begin self-care, their pain was controlled utilizing an oral regimen, and they were able to tolerate oral medication intake.
- Conditions
- Pain, Postoperative
- Being tested
- Liposomal Bupivacaine, 0.25% Bupivacaine with epinephrine, Saline
- Keywords
- Exparel, total hip replacement, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Exparel
266mg liposomal bupivacaine
0.25% Bupivacaine with epinephrineDrug
Also called Marcaine
0.25% bupivacaine with epinephrine
SalineDrug
Also called Saline solution
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine Receives: Drug: Liposomal Bupivacaine; Drug: 0.25% Bupivacaine with epinephrine; Drug: Saline |
| Bupivacaine with epinephrine | Active comparator | Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine Receives: Drug: 0.25% Bupivacaine with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Morphine Equivalent Consumption
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.
Measured: 72 hours postoperation, divided into six 12-hour periods
Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score
Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.
Measured: 72 hours post-operation, divided into six 12-hour periods
Time to Ambulation More Than 20 Feet (in Hours)
The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.
Measured: from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
Length of Stay (LOS, in Days)
Measured: From time of surgery until patient is discharged, an average of 1.5 days.
Number of Patients That Experienced a Fall
Measured: 72 hours postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Hip Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Domb, American Hip Institute
- Investigators
- Benjamin G Domb, MD, Principal investigator, American Hip Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001453
- Sponsor's protocol ID
- AHI-001
- Status last verified
- Jun 2018
- First submitted
- 8 Nov 2016
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Perets I, Walsh JP, Mu BH, Yuen LC, Ashberg L, Battaglia MR, Domb BG. Intraoperative Infiltration of Liposomal Bupivacaine vs Bupivacaine Hydrochloride for Pain Management in Primary Total Hip Arthroplasty: A Prospective Randomized Trial. J Arthroplasty. 2018 Feb;33(2):441-446. doi: 10.1016/j.arth.2017.09.013. Epub 2017 Sep 20.
PubMed 29033152
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.
- ClinicalTrials.gov ID
- NCT03001453
- Acronym / sponsor ID
- AHI-001
- Conditions
- Pain, Postoperative
- Keywords
- Exparel, total hip replacement, bupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- American Hip InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 26 Jul 2018
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 two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.
Detailed description
All surgeries were performed by the same orthopaedic surgeon. Two groups, one receiving Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine (LB group) and the other receiving bupivacaine with epinephrine (Control group), will be compared using post-operative pain scores, hospital length of stay, time to ambulation, falls, narcotic use, and narcotic-related adverse effects. Aside from hospital length of stay, all outcomes were recorded for up to 72 hours following surgery. An a priori power analysis was performed to calculate the total number of patients that needed to be enrolled to achieve a minimum 90% power, with the threshold of statistical significance set to 0.05. Based on a previous study reporting a mean oral opioid consumption of 57.04mg ± 25.6 at 24 hours post THR, a mean difference of 17.14mg was considered to be clinically significant. Thus, at least 26 patients were necessary in each group for an adequately powered assessment. The diagnosis for osteoarthritis was determined by patient history, physical examination, and imaging findings. Each patient received a thorough explanation of the protocol, and willing patients signed an informed consent form. All patients underwent a personal preoperative education program regarding pre, intra-, and post-procedural information including physical therapy, expectations, discharge goals, home therapy, and pain management. After written consent was collected, the form was sent to the hospital pharmacy for randomization. Envelopes were randomized, sealed, numbered, and given to the pharmacy staff, ultimately dispensing the envelopes to the nurse in the operating room in numerical order. The pharmacy documented the required information, selected medication, and drug accountability forms according to the contents of the envelopes.
A nurse delivered study drugs to the operating room in a sealed, non-descriptive envelope. During the standard anterior approach procedure, an anesthesiologist administered fentanyl or hydromorphone as needed for analgesia. The local anesthetics were administered after reduction of the implants. Patients in the LB group received 20cc liposomal bupivacaine, 40cc 0.25% bupivacaine with epinephrine, and 20cc of normal saline. Each patient in the control group received 60cc of 0.25% bupivacaine with epinephrine. Using a 20-gauge spinal needle, the local anesthetics were injected using a deep tissue administration technique. Structures innervated by the femoral nerve, superior gluteal nerve, or lateral femoral cutaneous nerve were considered suitable for injection. Throughout administration, frequent aspirations were performed to check for blood and minimize the risk of intravascular injection. The patients, surgical team, and floor staff was blinded to the local anesthetic drugs given.
During hospitalization, patients were observed, evaluated and treated according to postoperative protocols. Patients received opioids for pain management as needed, which was routinely documented by hospital staff. Opioids included fentanyl, hydromorphone, oxycodone, codeine, tramadol, morphine, and hydrocodone. All opioid dosages were converted into morphine equivalent dosages for analysis. Each patient began physical therapy within the first 24 hours postoperatively. Patients were discharged when they were able to begin self-care, their pain was controlled utilizing an oral regimen, and they were able to tolerate oral medication intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Drug: Liposomal Bupivacaine, Drug: 0.25% Bupivacaine with epinephrine, Drug: SalinePeriarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine |
| Bupivacaine with epinephrine | Active comparator | Drug: 0.25% Bupivacaine with epinephrinePeriarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo primary unilateral total hip replacement
- Patients diagnosed with hip osteoarthritis
- Patients failed to improve with conservative measures
- Patients willing and able to sign informed consent
Key exclusion criteria (5 listed)
- Revision total hip replacement
- Bilateral total hip replacement
- Birmingham hip resurfacing
- Patients with hepatic/kidney disease
- Patients with a known allergy to bupivacaine or other local anesthetics
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: Exparel266mg liposomal bupivacaine | Drug | Liposomal bupivacaine |
| 0.25% Bupivacaine with epinephrineAlso: Marcaine0.25% bupivacaine with epinephrine | Drug | Bupivacaine with epinephrine, Liposomal bupivacaine |
| SalineAlso: Saline solutionNormal saline | Drug | Liposomal bupivacaine |
Primary outcome
Patient Morphine Equivalent Consumption
Time frame: 72 hours postoperation, divided into six 12-hour periods
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.
Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score
Time frame: 72 hours post-operation, divided into six 12-hour periods
Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.
Time to Ambulation More Than 20 Feet (in Hours)
Time frame: from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.
Length of Stay (LOS, in Days)
Time frame: From time of surgery until patient is discharged, an average of 1.5 days.
Number of Patients That Experienced a Fall
Time frame: 72 hours postoperation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29033152Perets I, Walsh JP, Mu BH, Yuen LC, Ashberg L, Battaglia MR, Domb BG. Intraoperative Infiltration of Liposomal Bupivacaine vs Bupivacaine Hydrochloride for Pain Management in Primary Total Hip Arthroplasty: A Prospective Randomized Trial. J Arthroplasty. 2018 Feb;33(2):441-446. doi: 10.1016/j.arth.2017.09.013. Epub 2017 Sep 20.
- Individual participant dataSharing planned: No
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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.
Benjamin G Domb, MD principal investigator
American Hip Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Bupivacaine, 0.25% Bupivacaine with epinephrine and Saline in people with Pain, Postoperative, run by American Hip Institute at 2 sites in United States.
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 4 inclusion and 5 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Jul 2018). 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?
Patient Morphine Equivalent Consumption (time frame: 72 hours postoperation, divided into six 12-hour periods). The study lists 5 primary outcomes in all. 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 NCT03001453, 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 26 Jul 2018.