Osteoarthritis, HipPhase 4NCT03090152
Minimal Opioid Use After Total Hip Replacement (THR)
A Phase 4 study testing Periarticular injection (Deep injection), Periarticular injection (Superficial injection) and Bupivacaine in people with Osteoarthritis, Hip, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Periarticular injection (Deep injection), Periarticular injection (Superficial injection) and Bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 27 Sep 2019
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
- Planned use of regional anesthesia
- Planned posterolateral surgical approach
- Age Range 45-80
- Ability to follow study protocol
Who cannot join
- Any patient with age <45 or >80
- Any patient with planned anterior surgical approach
- Any patient with prior major ipsilateral hip surgery
- Any patient intending to receive general anesthesia
- Any patient with an ASA of IV
- Any patient with insulin-dependent diabetes
Show all 17Show fewer
- Any patient with hepatic (liver) failure (history of cirrhosis or elevated LFT's)
- Any patient with chronic renal (kidney) failure (formal diagnosis of renal disease of elevated creatinine)
- Any patient with history of gastric (stomach) ulcer
- Chronic opioid use (taking opioids for >3 mo duration on a daily basis)
- Chronic analgesic use (i.e. lyrica, gabapentin) for >3 mo duration
- Stress dose steroids
- Use of antidepressants
- Contraindications to aspirin
- Allergy to any of the medications (or adhesives) involved in the study protocol
- Dementia
- Non-English speakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study
Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. In a previous study done by the investigators' group, epidural patient controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more favorable pain profile with ambulation, but greater side effects compared to injection of a peri-articular cocktail. The use of opioid was greater in the peri-articular injection group (PAI). There was no difference in length of stay. In view of the controversy over opioid use, the investigators would like to develop an optimal opioid sparing pain management approach by comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain control while minimizing opioid use and side-effects.
Read the detailed description
Long acting narcotics or scheduled doses of narcotics are often used as part of a multimodal pain regimen. In this study, this is eliminated. Instead, it uses a cocktail of different drugs including intraoperative Ketamine use (NMDA receptor antagonist), intra-op Benadryl (to decrease excitation of nociceptors) and IV Tylenol. The narcotic free regimen starts preoperatively with the use of Aspirin,Clonidine patch, Cymbalta (Duloxetine), and is maintained both intraoperatively and post operatively. Baby ASA (81mg) is being used as an anti-inflammatory agent. A number of studies including the one by Morris et al. (2009), have shown via in vitro experiments that low dose aspirin decreases polymorphonuclear leukocyte and macrophage accumulation. It inhibits thromboxane making it an antithrombotic agent as well. The concern with aspirin has been major bleeding. Several studies in the orthopedic patient population using ≤81 mg of aspirin have shown that it does not increase bleeding (Cuellar, Mantz). At HSS, patients are routinely continued on baby aspirin when needed for its cardio protective effect. Devereaux in the POISE trial did show an increased risk of bleeding when ASA was given preoperatively at a dose of 200 mg. In our study, all patients will be given intravenous tranexamic acid which should mitigate against the risk of bleeding. Duloxetine is also being added. In a recent study done at HSS. Duloxetine was found to decrease the amount of opioid use and nausea. If found to be more effective with the use of EPCA vs. PAI or combination of the two, a new way of managing postop pain while minimizing Nnartcuoreti co fu Ssetu adsy per CDC recommendation will be helpful in managing patients post-operatively.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Periarticular injection (Deep injection), Periarticular injection (Superficial injection), Bupivacaine, Placebo
- Keywords
- Total Hip Replacement, Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular injection (Deep injection)Procedure or surgery
Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection)Procedure or surgery
Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
BupivacaineDrug
EPCA: Bupivacaine 0.06%.
PlaceboDrug
EPCA: Saline.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular Injection (PAI) | Active comparator | * Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it. Receives: Procedure: Periarticular injection (Deep injection); Procedure: Periarticular injection (Superficial injection); Drug: Placebo |
| Epidural Patient-Controlled Analg (EPCA) | Active comparator | * Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it. Receives: Drug: Bupivacaine |
| PAI + EPCA | Experimental | * Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it. Receives: Procedure: Periarticular injection (Deep injection); Procedure: Periarticular injection (Superficial injection); Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use
Oral morphine equivalents, cumulative
Measured: within 24 hours after surgery
Secondary outcomes (11)
Pain at Rest
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Measured: Postoperative Day 1,2,3,7,90
Pain With Activity
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Measured: Postoperative Day 1,2,3,7,90
Opioid Side Effects
via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.
Measured: Postoperative Day 1,2
Patient Satisfaction
via Likert scale. A higher score is a better outcome. the scale is from 0-10.
Measured: Postoperative Day 1,2,3,7
Post-operative Pain
via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.
Measured: Postoperative Day 1
Neuropathic Pain Assessed With S-LANSS
via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.
Measured: Postoperative Day 7, Postoperative Day 90
Quality of Recovery
Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome
Measured: Postoperative Day 1,2,3
Readiness for Discharge Time
When patient meets all readiness for discharge criteria
Measured: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
Blinding Assessment
What group do you think you were in
Measured: Assessed on day of discharge and on seventh post operative day
Opioid Consumption During the First 3 Days Post-op
Opioids consumed in the first 3 after surgery (cumulative consumption).
Measured: Postoperative day 0,1,2,3
No Opioids Consumed
Number of patients who did not consume any opioids
Measured: 0 to 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start8 Mar 2017
- Primary completion28 Jun 2019
- Study completion27 Sep 2019
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, HipStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kethy Jules-Elysee, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090152
- Sponsor's protocol ID
- 2016-0721
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2017
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03090152
- Acronym / sponsor ID
- 2016-0721
- Conditions
- Osteoarthritis, Hip
- Keywords
- Total Hip Replacement, Total Hip Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 27 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total hip arthroplasty can be associated with significant postoperative pain. Side effects of pain management may impair participation in physical therapy and slow readiness for discharge from the hospital. In a previous study done by the investigators' group, epidural patient controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more favorable pain profile with ambulation, but greater side effects compared to injection of a peri-articular cocktail. The use of opioid was greater in the peri-articular injection group (PAI). There was no difference in length of stay. In view of the controversy over opioid use, the investigators would like to develop an optimal opioid sparing pain management approach by comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain control while minimizing opioid use and side-effects.
Detailed description
Long acting narcotics or scheduled doses of narcotics are often used as part of a multimodal pain regimen. In this study, this is eliminated. Instead, it uses a cocktail of different drugs including intraoperative Ketamine use (NMDA receptor antagonist), intra-op Benadryl (to decrease excitation of nociceptors) and IV Tylenol. The narcotic free regimen starts preoperatively with the use of Aspirin,Clonidine patch, Cymbalta (Duloxetine), and is maintained both intraoperatively and post operatively. Baby ASA (81mg) is being used as an anti-inflammatory agent. A number of studies including the one by Morris et al. (2009), have shown via in vitro experiments that low dose aspirin decreases polymorphonuclear leukocyte and macrophage accumulation. It inhibits thromboxane making it an antithrombotic agent as well. The concern with aspirin has been major bleeding. Several studies in the orthopedic patient population using ≤81 mg of aspirin have shown that it does not increase bleeding (Cuellar, Mantz). At HSS, patients are routinely continued on baby aspirin when needed for its cardio protective effect. Devereaux in the POISE trial did show an increased risk of bleeding when ASA was given preoperatively at a dose of 200 mg. In our study, all patients will be given intravenous tranexamic acid which should mitigate against the risk of bleeding. Duloxetine is also being added. In a recent study done at HSS. Duloxetine was found to decrease the amount of opioid use and nausea. If found to be more effective with the use of EPCA vs. PAI or combination of the two, a new way of managing postop pain while minimizing Nnartcuoreti co fu Ssetu adsy per CDC recommendation will be helpful in managing patients post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periarticular Injection (PAI) | Active comparator | Procedure: Periarticular injection (Deep injection), Procedure: Periarticular injection (Superficial injection), Drug: Placebo* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. * Peri-articular injection in the operating room * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it. |
| Epidural Patient-Controlled Analg (EPCA) | Active comparator | Drug: Bupivacaine* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it. |
| PAI + EPCA | Experimental | Procedure: Periarticular injection (Deep injection), Procedure: Periarticular injection (Superficial injection), Drug: Bupivacaine* Aspirin and nerve pain medications including duloxetine and clonidine * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * Anesthetic, Antiemetic and peri-articular injection in the operating room * A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any patient with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
- Planned use of regional anesthesia
- Planned posterolateral surgical approach
- Age Range 45-80
- Ability to follow study protocol
Key exclusion criteria (17 listed)
- Any patient with age <45 or >80
- Any patient with planned anterior surgical approach
- Any patient with prior major ipsilateral hip surgery
- Any patient intending to receive general anesthesia
- Any patient with an ASA of IV
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 injection (Deep injection)Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata. | Procedure or surgery | PAI + EPCA, Periarticular Injection (PAI) |
| Periarticular injection (Superficial injection)Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure. | Procedure or surgery | PAI + EPCA, Periarticular Injection (PAI) |
| BupivacaineEPCA: Bupivacaine 0.06%. | Drug | Epidural Patient-Controlled Analg (EPCA), PAI + EPCA |
| PlaceboEPCA: Saline. | Drug | Periarticular Injection (PAI) |
Primary outcome
Opioid Use
Time frame: within 24 hours after surgery
Oral morphine equivalents, cumulative
11 secondary outcomes
Pain at Rest
Time frame: Postoperative Day 1,2,3,7,90
Pain With Activity
Time frame: Postoperative Day 1,2,3,7,90
Opioid Side Effects
Time frame: Postoperative Day 1,2
Patient Satisfaction
Time frame: Postoperative Day 1,2,3,7
Post-operative Pain
Time frame: Postoperative Day 1
Neuropathic Pain Assessed With S-LANSS
Time frame: Postoperative Day 7, Postoperative Day 90
Quality of Recovery
Time frame: Postoperative Day 1,2,3
Readiness for Discharge Time
Time frame: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
Blinding Assessment
Time frame: Assessed on day of discharge and on seventh post operative day
Opioid Consumption During the First 3 Days Post-op
Time frame: Postoperative day 0,1,2,3
No Opioids Consumed
Time frame: 0 to 24 hours post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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.
Kethy Jules-Elysee, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Periarticular injection (Deep injection), Periarticular injection (Superficial injection) and Bupivacaine in people with Osteoarthritis, Hip, run by Hospital for Special Surgery, New York at 1 site 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 5 inclusion and 17 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 27 Dec 2024. 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 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 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 27 Jul 2022). 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?
Opioid Use (time frame: within 24 hours 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 27 Dec 2024.