SurgeryEarly Phase 1NCT03774966
IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?
A Early Phase 1 study testing Adductor Canal Block + Catheter & IPACK block and Adductor canal block + catheter in people with Surgery and Acute Pain, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Acute Pain
- What is being tested?
- Adductor Canal Block + Catheter & IPACK block and Adductor canal block + catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 28 May 2019
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee replacement without contraindications to regional blocks
Who cannot join
- Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
About this study
Official title: Do Patients Who Receive the IPACK and Adductor Canal Catheter Have Better Outcomes Than Patients Receiving the Adductor Canal Catheter Alone for Total Knee Replacements?
This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only.
Read the detailed description
Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant post-operative pain. Poor pain control in the post-operative period has contributed to delays in early mobility and rehabilitation, an important part of recovery that is best started as soon as possible after surgery. Regional techniques in general have helped manage post-operative pain as well as minimize narcotic use. The application of femoral and sciatic nerve blocks has been shown to decrease opioid use; however, they were associated with adverse events such as quadriceps weakness and falls post-operatively. This led to the development of the adductor canal block (ACB) which has gained favor for providing superior analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle. Recently, adding local anesthetic to the interspace between the popliteal artery and posterior capsule of the knee (IPACK) blocks have been used to help address pain in the posterior part of the knee that is not well covered by the adductor canal block alone. While the sciatic nerve block is also an option to cover this area, it is associated with foot drop which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of practice is the ACB. The investigators hope to show with this study that adopting this novel block will help with post-operative pain control, decrease length of hospital stay, and increase distance walked during physical therapy.
- Conditions
- Surgery, Acute Pain
- Being tested
- Adductor Canal Block + Catheter & IPACK block, Adductor canal block + catheter
- Keywords
- total knee arthroplasty, regional block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block + Catheter & IPACK blockProcedure or surgery
Adductor Canal Block + Catheter \& IPACK block
Adductor canal block + catheterProcedure or surgery
Adductor canal block + catheter
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block + Catheter | Active comparator | Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine Receives: Procedure: Adductor canal block + catheter |
| Adductor Canal Block + Catheter & IPACK | Experimental | Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine. Receives: Procedure: Adductor Canal Block + Catheter & IPACK block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in milligram morphine equivalents
Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.
Measured: 4 days
Secondary outcomes (2)
Visual analog pain scores
Pain scores will be assessed postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded every 4 to 6 hours by the nurse monitoring the subject.
Measured: 4 days
Distance ambulated during physical therapy
Distance (meters) ambulated during physical therapy will be recorded for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start12 Feb 2019
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Boyd, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774966
- Sponsor's protocol ID
- 18-001490
- Status last verified
- Feb 2020
- First submitted
- 4 Dec 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.
PubMed 28283810Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
PubMed 29026354
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients Who Receive the IPACK and Adductor Canal Catheter Have Better Outcomes Than Patients Receiving the Adductor Canal Catheter Alone for Total Knee Replacements?
- ClinicalTrials.gov ID
- NCT03774966
- Acronym / sponsor ID
- 18-001490
- Conditions
- Surgery, Acute Pain
- Keywords
- total knee arthroplasty, regional block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 13 Dec 2018 (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.
This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only.
Detailed description
Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant post-operative pain. Poor pain control in the post-operative period has contributed to delays in early mobility and rehabilitation, an important part of recovery that is best started as soon as possible after surgery. Regional techniques in general have helped manage post-operative pain as well as minimize narcotic use. The application of femoral and sciatic nerve blocks has been shown to decrease opioid use; however, they were associated with adverse events such as quadriceps weakness and falls post-operatively. This led to the development of the adductor canal block (ACB) which has gained favor for providing superior analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle. Recently, adding local anesthetic to the interspace between the popliteal artery and posterior capsule of the knee (IPACK) blocks have been used to help address pain in the posterior part of the knee that is not well covered by the adductor canal block alone. While the sciatic nerve block is also an option to cover this area, it is associated with foot drop which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of practice is the ACB. The investigators hope to show with this study that adopting this novel block will help with post-operative pain control, decrease length of hospital stay, and increase distance walked during physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block + Catheter | Active comparator | Procedure: Adductor canal block + catheterAdductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine |
| Adductor Canal Block + Catheter & IPACK | Experimental | Procedure: Adductor Canal Block + Catheter & IPACK blockAdductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total knee replacement without contraindications to regional blocks
Key exclusion criteria (1 listed)
- Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder
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 |
|---|---|---|
| Adductor Canal Block + Catheter & IPACK blockAdductor Canal Block + Catheter \& IPACK block | Procedure or surgery | Adductor Canal Block + Catheter & IPACK |
| Adductor canal block + catheterAdductor canal block + catheter | Procedure or surgery | Adductor Canal Block + Catheter |
Primary outcome
Opioid consumption in milligram morphine equivalents
Time frame: 4 days
Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.
2 secondary outcomes
Visual analog pain scores
Time frame: 4 days
Distance ambulated during physical therapy
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 28283810Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.
- Results publication: PubMed 29026354Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
- 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 Early Phase 1 study testing Adductor Canal Block + Catheter & IPACK block and Adductor canal block + catheter in people with Surgery and Acute Pain, run by University of California, Los Angeles 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 1 inclusion and 1 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 19 Feb 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 consumption in milligram morphine equivalents (time frame: 4 days). 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 NCT03774966, which also lists 2 linked publications.
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 19 Feb 2020.