OsteoarthritisPhase 4NCT03119038
Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement
A Phase 4 study testing Bupivicaine + epinephrine, Bupivacaine and Ropivacaine in people with Osteoarthritis and Degenerative Joint Disease, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to clarify the efficacy of a multidrug versus single drug periarticular injection when only standard operative and postoperative pain management protocols used and the control group is exposed to what our investigators believe is the standard of care, single medication periarticular… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Degenerative Joint Disease
- What is being tested?
- Bupivicaine + epinephrine, Bupivacaine and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2016to 25 Oct 2022
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be male or female of any race
- Ages 18-80 years old
- Patients must have a primary hip arthroplasty by principal investigator or co-investigator
Who cannot join
- Allergy or intolerance to the study materials
- Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
- History of previous surgeries on the affected joint other ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 than arthroscopy (open surgeries)
- History of or current substance abuse or addiction
- History of or current psychiatric diagnosis
- Failure in collecting a required data point during study
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study
The purpose of this study is to clarify the efficacy of a multidrug versus single drug periarticular injection when only standard operative and postoperative pain management protocols used and the control group is exposed to what our investigators believe is the standard of care, single medication periarticular injection
Read the detailed description
Study Objectives The intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution will be compared to an injection of 30 mL of a 0.25% solution bupivacaine with ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 epinephrine and 30 mL 0.25% bupivacaine without epinephrine as an intraoperative periarticular joint injection protocol. The study's data collection timeline begins at the pre-operative clinic visit. Data collection continues through the patient's discharge after the surgical procedure and until the first year postoperative visit examination of joint range of motion and patient satisfaction questionnaires.
Primary Objectives:
The primary objective is to evaluate the efficacy of a multidrug versus bupivacaine intraoperative injection in decreasing total hip arthroplasty postoperative pain. To determine this, postoperative analgesic consumption will be collected for each patient and the value when converted to morphine equivalents will be compared between cohorts.
Analysis of morphine equivalent values at various postoperative time intervals (0-6 hours, 6-12 hours, 12-18, 18-24, then each postoperative day) and total morphine equivalent consumption for the entire length of stay will be performed between treatment cohorts.
Secondary Objectives:
To establish the improvement in postoperative pain relief provided by intraoperative periarticular injection of our multidrug protocol versus bupivacaine, other data points will be collected. The physical therapy milestones including time to first get out of bed, time to ambulation with or without assistance, time to climb stairs, and time to active straight leg raise will all be collected. The zero time point will be the end of the operation. Pain scale scores during physical therapy sessions with physiotherapists will also be recorded.
Resting visual analog scores for pain assessment will be collected as the patient representing their pain on a scale from 0 to 100 mm. The VAS values will be collected at various postoperative time values until discharge. The length of hospital stay will be collected as well. Opioid side effects will also be collected including over sedation, respiratory depression, urinary retention, and constipation. Other data collected will include operation time, wound complications, intraoperative blood loss, and postoperative drain output. At the 6 weeks postoperative visit, patient satisfaction questionnaires will be collected compared to preoperative visit values.
- Conditions
- Osteoarthritis, Degenerative Joint Disease
- Being tested
- Bupivicaine + epinephrine, Bupivacaine, Ropivacaine, Ketorolac, Clonidine Injection
- Keywords
- total hip, degenerative joint disease, osteoarthritis
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivicaine + epinephrineDrug
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine
BupivacaineDrug
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine without epinephrine
RopivacaineDrug
Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine
KetorolacDrug
Intraoperative periarticular injection of 30 mg
Clonidine InjectionDrug
Intraoperative periarticular injection of 100 mcg clonidine in a 100 mL 0.9% saline solution
| Study group | Role | What they receive |
|---|---|---|
| Combination Medication Injection | Active comparator | Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution Receives: Drug: Ropivacaine; Drug: Ketorolac; Drug: Clonidine Injection |
| Single Medication Injection | Active comparator | Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine and 30 mL 0.25% bupivacaine without epinephrine Receives: Drug: Bupivicaine + epinephrine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.
Narcotic usage
Measured: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Secondary outcomes (3)
Record time to achieve physical therapy milestones during inpatient physical therapy
Time to achieve physical therapy milestones
Measured: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Record VAS values during postoperative period
VAS values
Measured: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Length of hospital stay
Length of stay
Measured: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start30 Apr 2016 (estimated)
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Why it stopped: Investigator no longer actively pursuing this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Levine, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119038
- Sponsor's protocol ID
- ORA-15101602
- Status last verified
- Oct 2022
- First submitted
- 10 Apr 2017
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03119038
- Acronym / sponsor ID
- ORA-15101602
- Conditions
- Osteoarthritis, Degenerative Joint Disease
- Keywords
- total hip, degenerative joint disease, osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator no longer actively pursuing this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 30 Apr 2016 (estimated)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
The purpose of this study is to clarify the efficacy of a multidrug versus single drug periarticular injection when only standard operative and postoperative pain management protocols used and the control group is exposed to what our investigators believe is the standard of care, single medication periarticular injection
Detailed description
Study Objectives The intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution will be compared to an injection of 30 mL of a 0.25% solution bupivacaine with ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 epinephrine and 30 mL 0.25% bupivacaine without epinephrine as an intraoperative periarticular joint injection protocol. The study's data collection timeline begins at the pre-operative clinic visit. Data collection continues through the patient's discharge after the surgical procedure and until the first year postoperative visit examination of joint range of motion and patient satisfaction questionnaires.
Primary Objectives:
The primary objective is to evaluate the efficacy of a multidrug versus bupivacaine intraoperative injection in decreasing total hip arthroplasty postoperative pain. To determine this, postoperative analgesic consumption will be collected for each patient and the value when converted to morphine equivalents will be compared between cohorts.
Analysis of morphine equivalent values at various postoperative time intervals (0-6 hours, 6-12 hours, 12-18, 18-24, then each postoperative day) and total morphine equivalent consumption for the entire length of stay will be performed between treatment cohorts.
Secondary Objectives:
To establish the improvement in postoperative pain relief provided by intraoperative periarticular injection of our multidrug protocol versus bupivacaine, other data points will be collected. The physical therapy milestones including time to first get out of bed, time to ambulation with or without assistance, time to climb stairs, and time to active straight leg raise will all be collected. The zero time point will be the end of the operation. Pain scale scores during physical therapy sessions with physiotherapists will also be recorded.
Resting visual analog scores for pain assessment will be collected as the patient representing their pain on a scale from 0 to 100 mm. The VAS values will be collected at various postoperative time values until discharge. The length of hospital stay will be collected as well. Opioid side effects will also be collected including over sedation, respiratory depression, urinary retention, and constipation. Other data collected will include operation time, wound complications, intraoperative blood loss, and postoperative drain output. At the 6 weeks postoperative visit, patient satisfaction questionnaires will be collected compared to preoperative visit values.
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 |
|---|---|---|
| Combination Medication Injection | Active comparator | Drug: Ropivacaine, Drug: Ketorolac, Drug: Clonidine InjectionIntraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution |
| Single Medication Injection | Active comparator | Drug: Bupivicaine + epinephrine, Drug: BupivacaineIntraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine and 30 mL 0.25% bupivacaine without epinephrine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be male or female of any race
- Ages 18-80 years old
- Patients must have a primary hip arthroplasty by principal investigator or co-investigator
Key exclusion criteria (6 listed)
- Allergy or intolerance to the study materials
- Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
- History of previous surgeries on the affected joint other ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 than arthroscopy (open surgeries)
- History of or current substance abuse or addiction
- History of or current psychiatric diagnosis
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 |
|---|---|---|
| Bupivicaine + epinephrineIntraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine | Drug | Single Medication Injection |
| BupivacaineIntraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine without epinephrine | Drug | Single Medication Injection |
| RopivacaineIntraoperative periarticular injection of 300 mg of 0.5% ropivacaine | Drug | Combination Medication Injection |
| KetorolacIntraoperative periarticular injection of 30 mg | Drug | Combination Medication Injection |
| Clonidine InjectionIntraoperative periarticular injection of 100 mcg clonidine in a 100 mL 0.9% saline solution | Drug | Combination Medication Injection |
Primary outcome
Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.
Time frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Narcotic usage
3 secondary outcomes
Record time to achieve physical therapy milestones during inpatient physical therapy
Time frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Record VAS values during postoperative period
Time frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Length of hospital stay
Time frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bupivicaine + epinephrine, Bupivacaine and Ropivacaine in people with Osteoarthritis and Degenerative Joint Disease, run by Rush University Medical Center 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 27 Oct 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay. (time frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first). 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 Oct 2022.