Hip ArthropathyPhase 2NCT03977454
Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty
A Phase 2 study testing Nerve Block, Periarticular Injection (PAI) and Ropivacaine in people with Hip Arthropathy, run by Yale University at 1 site in United States.
Trial summary
This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Nerve Block, Periarticular Injection (PAI) and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 19 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective unilateral primary THA
- All surgical approaches
- American Society of Anesthesiologist (ASA) status I, II and III.
Who cannot join
- Patient refusal;
- Age less than 18 years
- Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team;
- Coagulopathy;
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital St Raphael
New Haven, Connecticut, 06511
About this study
Official title: Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study
This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).
Read the detailed description
To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes:
Primary outcome: Daily opioid consumption
Secondary outcomes:
Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays.
Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection.
When results were entered, the detailed description was updated to reflect the outcome measures used in the study.
- Conditions
- Hip Arthropathy
- Being tested
- Nerve Block, Periarticular Injection (PAI), Ropivacaine, Dex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockProcedure or surgery
Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.
- QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
- LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
Periarticular Injection (PAI)Procedure or surgery
Intraoperatively, the surgeon will perform PAI per standard of care with the medications:
- 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA
RopivacaineDrug
60 ml 0.2% ropivacaine
DexDrug
10 mg DEX/ 80 mg MPA
| Study group | Role | What they receive |
|---|---|---|
| Group 1 patients will receive nerve block per standard of care | Experimental | Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service.
1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and
2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. Receives: Procedure: Nerve Block; Drug: Ropivacaine |
| Group 2 will NOT receive any nerve blocks. | Active comparator | Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. Receives: Procedure: Periarticular Injection (PAI); Drug: Ropivacaine; Drug: Dex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Opioid Consumption
Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.
Measured: Up to 72 hours
Secondary outcomes (4)
Change in Pain Intensity While in Hospital
Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.
Measured: Up to 2 days
Length of Stay
The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital.
Measured: Up to 5 days
Harris Hip Score
The Harris Hip Score (HHS) assesses post operative conditions following hip surgery. The HHS uses a 100 point score wherethe scores are interpreted as follows: < 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent.
Measured: 2 weeks post operation
Brief Pain Inventory: Interference
The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference.
Measured: 2 weeks post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start11 Nov 2019
- Primary completion19 Jun 2021
- Study completion19 Jun 2021
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 Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinlei Li, MD PhD FASA, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977454
- Sponsor's protocol ID
- 2000025198
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2019
- Last updated
- 23 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study
- ClinicalTrials.gov ID
- NCT03977454
- Acronym / sponsor ID
- 2000025198
- Conditions
- Hip Arthropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 19 Jun 2021 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Posted 23 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).
Detailed description
To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes:
Primary outcome: Daily opioid consumption
Secondary outcomes:
Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays.
Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection.
When results were entered, the detailed description was updated to reflect the outcome measures used in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 patients will receive nerve block per standard of care | Experimental | Procedure: Nerve Block, Drug: RopivacaineNerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service. 1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and 2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI. |
| Group 2 will NOT receive any nerve blocks. | Active comparator | Procedure: Periarticular Injection (PAI), Drug: Ropivacaine, Drug: DexIntraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective unilateral primary THA
- All surgical approaches
- American Society of Anesthesiologist (ASA) status I, II and III.
Key exclusion criteria (4 listed)
- Patient refusal;
- Age less than 18 years
- Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team;
- Coagulopathy;
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 |
|---|---|---|
| Nerve BlockNerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service. 1. QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA 2. LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA | Procedure or surgery | Group 1 patients will receive nerve block per standard of care |
| Periarticular Injection (PAI)Intraoperatively, the surgeon will perform PAI per standard of care with the medications: 1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA | Procedure or surgery | Group 2 will NOT receive any nerve blocks. |
| Ropivacaine60 ml 0.2% ropivacaine | Drug | Group 1 patients will receive nerve block per standard of care, Group 2 will NOT receive any nerve blocks. |
| Dex10 mg DEX/ 80 mg MPA | Drug | Group 2 will NOT receive any nerve blocks. |
Primary outcome
Daily Opioid Consumption
Time frame: Up to 72 hours
Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.
4 secondary outcomes
Change in Pain Intensity While in Hospital
Time frame: Up to 2 days
Length of Stay
Time frame: Up to 5 days
Harris Hip Score
Time frame: 2 weeks post operation
Brief Pain Inventory: Interference
Time frame: 2 weeks post operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hip Arthropathy
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SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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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.
Jinlei Li, MD PhD FASA principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nerve Block, Periarticular Injection (PAI) and Ropivacaine in people with Hip Arthropathy, run by Yale University 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 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 23 Sep 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 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 23 Sep 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?
Daily Opioid Consumption (time frame: Up to 72 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 23 Sep 2022.